Chapter 1 To V (2) - Merged

“A STUDY TO ASSESSTHE EFFECTIVENESS OF HELFER
SKIN TAP TECHNIQUE ON PAIN REDUCTION AMONG

INFANTS DURING INTRAMUSCULAR VACCINATION
AT SELECTED PEDIATRIC HOSPITALS,
HYDERABAD”
BY
KUMBHAM NIHARIKA
VIJAY MARIE COLLEGE OF NURSINGBEGUMPET,
HYDERABAD 16, TELANGANA
KNR UNIVERSITY OF HEALTH SCIENCES
WARANGAL, TELANGANA
JULY 2023
DECLARATION BY THE CANDIDATE
I hereby declare that this dissertation thesis entitled “A study to assess the
effectiveness of Helfer Skin Tap Technique on pain reduction among infants
during intramuscular vaccination at pediatric hospitals, Hyderabad” is a
Bonafide and genuine research carried out by me under the guidance of Sr.
Nirmala. Pulipati, Professor, HOD of Child Health Nursing, Vijay Marie
College of Nursing, Hyderabad.
DATE: Signature of the Candidate

Place: Hyderabad kumbham Niharika
Vijay Marie College of Nursing
Begumpet, Hyderabad.
ABSTRACT
A True experimental study to evaluate the effectiveness of “A study to assess

the effectiveness of Helfer Skin Tap Technique on pain reduction among
infants during intramuscular vaccination at pediatric hospitals, Hyderabad”.
Study was conducted by Kumbham Niharika at Vijaya Marie College of
Nursing, Hyderabad, in partial fulfilment of the requirement for the degree of
M.Sc. Nursing. Kaloji sNarayana Rao University of Health Sciences,
Warangal, Telangana. During the year 2021-2022.
The objectives of the study were:
 To assess the level of pain among infants during Intra muscular

Vaccination in experimental group at selected in paediatrics hospitals
 To assess the level of pain among infants during intra muscular
vaccination in control group at selected in paediatrics hospitals.
 To determine the effectiveness of Helfer Skin Tap Technique among
infants during Intra muscular vaccination in reducing pain in
experimental group.
 To compare the level of pain among infants during Intra muscular
vaccination after receiving Helfer Skin Tap Technique in experimental
and control group.
 To find out the association between level of pain among infants during
intra muscular vaccination with Helfer Skin Tap Technique with their
selected demographic variables.
The conceptual framework adopted for the study was Wall And Malzack’s
Gate Control Theory. It was modified to suit the purpose of the study.
The research design adopted for the present study is True experimental post-
test control group design only design and During Intra Muscular Vaccination
dependent variables. The study was conducted at selected pediatric hospitals
in Hyderabad. The population for the present study was infants age 1 month –
12 month old in selected pediatric hospital, Hyderabad. The size of the
sample was sixty (thirty control and thirty experimental).
For the present study, the tool was administered consisting of demographic
variables and Modified FLACC Pain Scale after validating its content with
various experts in the field of Child Health Nursing to assess the effectiveness
of Helfer Skin Tap Technique on pain reduction among infants during Intra
Muscular vaccination at selected pediatric hospital, Hyderabad.
To find out the feasibility and reliability of the tool, a pilot study was conducted
from 22nd July 2022 to 27 July 2022 at Vijay Marie hospital, Khairatabad,
Hyderabad. The tool was found to be feasible and applicable to the main
study. The main study was conducted at Niloufer children’s Hospital, Red
Hills, Lakdikapul, during a specified period from 8th Aug 2022 to 16 Aug
2022. Data collected from sixty infants were organized, tabulated, and
analyzed with the help of descriptive and inferential statistics, and the findings
were interpreted.
MAJOR FINDINGS OF THE STUDY:
In control group majority of Infants developmental stage 30(100%) of infants

were between 1-6 months, 9(30%) were male, 21 (70%) were female, weight
of the baby 26 (86.6%) were between 3.6-4.5kg , 2(6.7%) were between 4.6-
5.5kg, 2(6.7%) were between 5.6-6.5kg ,educational status of father 2(6.7%)
were illiterate, 2(6.7%) had primary education,10(33.3%) had secondary
education,16(53.3%) were graduates, educational status of mother 3(10%)
were illiterate,10(33.3%) had primary education,11 (36.3%) had secondary
education,6(20%) were graduates, occupation of father2(6.7%) were
government employee,19 (63.3%) were private employee, 7(23.3%) were
business ,2(6.7%) were labour, occupation of mother 2(6.7%) were
government employee,10 (33.3%) were private Employee, 8(26.7%) were
business ,10(33.3%) were Housewife, type of delivery 14 (46.6%) were
Normal vaginal delivery ,12(40%) were LSCS, 2(6.7%) were vacuum2(6.7%)
were forceps, frequency of IM vaccination 3(10%) were1 ST Dose , 21(70%)
were 2nd Dose ,6(20%) were 3rd Dose vaccination
In Experimental group majority of Infants developmental stage 30 (100%)

infants were between 1month-6months, 11(36.7%) were male, 19(63.3%)
were female, weight of the baby 4(13.3%) were between 3.6-4-5kg
16(53.3%) were between 4.65.5kg,10(33.4%) were between 5.6-
6.5kg,education of father 4(13.3%) were illiterate ,10(33.3%) had primary
edcuation,5(16.7%) had secondary education 11(36.7%) were graduates,
education of mother 4(13.3%) were illiterate,10 (33.3%) had primary
education,5(16.7%) had secondary education,11(36.7%) were graduates
,occupation of father4(13.3%) were government employee, 16(53.3%)were
private Employee,8(26.7%) were business,2(6.7%) were labour, occupation of
mother1(3.3%)were government employee,11(36.7%),private
Employee,9(30%)were business,9(30%) were labour, type of
delivery10(33.3%) were normal vaginal delivery,15(50%) were
LSCS,3(10%)were vacuum,2(6.7%)were forceps, frequency of IM
vaccination2(6.7%)were 1st Dose,10(33.3%) were2nd Dose 18(60%) were 3rd
Dose of vaccination.
In control group majority of infants 23(76.67%) were relaxed and comfortable,

4(13.33%) had mild pain, 2(6.67%) had moderate pain 1(3.33%) experienced
severe pain.
Where as In experimental group majority of infants 27(90%) were relaxed and

comfortable, 2(6.67%) had moderate pain and 1(3.33%) experienced severe
pain.
The “t” test value in the control group before 1.57 and during 1.98 1st minute
0.28 and 5th minute 2.04 and 10th minute 1.90 and in the experimental group
before 10.20 during 8.77 and 1st minute 7.75 and 5th minute 5.20 and 10th
minute 2.52 is higher than the table value at 29 df, showing that Helfer Skin
Tap Technique on pain reduction among infants during intra muscular
vaccination between the control and experimental group is significant Helfer
Skin Tap Technique was effective reducing the pain.
Chi-square value will be computed to find out the association between level of
pain among infants during intra muscular vaccination with their selected
demographic variable in experimental group and control group.
The study leads to the following conclusions:
The following conclusions were drawn on the basis of the findings of the
study.
1. The main conclusion drawn from the present study was that most of the
infants had were, Relaxed and Comfortable, had Mild Pain, Moderate
Pain, and Severe Pain.
2. After receiving the Helfer Skin Tap Technique, level of pain during
intramuscular vaccination among infants was improved significantly.
3. It is thus concluded that the Helfer Skin Tap Technique is effective in
reducing pain during intra muscular vaccination.
The Study has drawn the following recommendations:
In the light of the findings listed above and the personal experience of the
investigator following suggestions are put forth:
1. The similar study can be conducted in large group of population.

2. The similar study can be conducted in all age group of children.
3. A study to can be conducted to assess the effectiveness of Helfer Skin
Tap Technique on pain reduction among children under going various
type of vaccination.
TABLE OF CONTENT
CHAPTER CONTENT PAGE

NO
I INTRODUCTION 1-8
9-13
 Need for the study
14
 Statement of the problem
14
 Objectives of the study
15
 Operational definition
16
 Hypothesis
17
 Research variables
17
 Assumptions of the study
18
 Limitations of the study
18-20
 Conceptual framework of the study
21
 Epilogue
22
II REVIEW OF LITERATURE
 Studies related to pain experience by 24-28
infants during immunization
 Studies related to Helfer Skin Tap

29-32
technique in reducing pain among
infants during intra muscular
vaccination.
 Studies related to effectiveness of 32-36
various interventions on reduction of
pain among Infants during intra muscular

vaccination.
37-38
III RESEARCH METHODOLOGY
39
 Research approach
39- 41
 Research design
42
 Setting of the study
43
 Population
44
 Sample technique
44
 Criteria for sample collection
45
 Development of the tool
45-47
 Description of the tool
48
 Validity
48
 Reliability
49
 Pilot study
50
 Data collection procedure
50-51
 Plan for data analysis
51
 Epilogue
IV DATA ANALYSIS AND INTERPRETATION 52-55
Section 1:
Frequency and percentage distribution of
infants according to their demographic

56-73
variables in experimental group and control
group.
Section 2:Assess the levels of pain among
74-77
infants during intra muscular vaccination in
experimental group and control group.
Section 3:
Mean and standard deviation to find out
significant difference between level of pain
among infants during intra muscular vaccination 78-80
in experimental group and control group.
Section 4:
Effectiveness of Helfer Skin Tap Technique
among infants during intra muscular vaccination 81-83
in experimental group and control group.
Section 5:
chi - square value will be computed to find out
the association between level of pain among 84-86
infants during intra muscular vaccination with
their selected demographic variable in
V SUMMARY,LIMITATION AND 87-88

RECOMMENDATION
89
 Summary
89-91
 Hypothesis
92-94
 Findings
 Discussion 94-96
 Implication 97-99
 Limitation 99
 Recommendations 100
 Conclusions 100
REFERENCE 101-108
APPENDICES
LIST OF TABLES
S NO TITLE PAGE NO
Frequency and percentage distribution of infants
1 56
according to their Developmental Stage.
2 58
according to their Gender of the Baby
3 60
according to their Weight of the Baby
4 62
according to their Educational status of father
5 64
according to their Educational status of mother
6 66
according to their Occupations of the father
7 68
according to their Occupations of the mother
8 70
according to their Type of Delivery
9 72
according to their Frequency of IM vaccination.
Frequency and Percentage of intra muscular
10 74
vaccination among infants in experimental group
Frequency and Percentage of intra muscular
11 76
vaccination among infants in control group.
Mean, standard deviation in experimental and
12 78
control group.
Comparison of pain level during intramuscular
13 vaccination among infants in experimental group 81
by using unpaired ‘t’ test.
Comparison level of pain among infants During
14 82
intra muscular vaccination pain in control group
by using paired ‘t’ test
Comparison of pain of intramuscular

vaccination pain between experimental and
15 83
control group of infants during intramuscular
vaccination by using unpaired ‘ t’ test
Association of selected demographic variable
with pain level of infants during intra muscular
16 85
vaccination in experimental group and control
group.
LIST OF FIGURES
PAGE
S.NO TITLE
NO
1 Conceptual frame work based on Gate Control theory 20
2 Schematic Representation of research methodology 41
Percentage distribution of infants according to their

3 57
Developmental Stage.
Percentage distribution of infants according to their Gender
4 59
of the Baby
Percentage distribution of infants according to their Weight
5 61
of the baby
6 63
Educational status of father
7s 65
Educational status of mother
8 67
Occupations of the father.
9 69
Occupations of the mother
Percentage distribution of infants according to their Type of
10 71
delivery
11 73
frequency of IM vaccination
Percentage distribution level of pain during intra muscular
12 75
vaccination among infants in experimental group.
Percentage distribution level of pain during Intra muscular
13 77
vaccination among infants in control group
14 Mean, Standard Deviation in experimental group 79
15 Mean, Standard Deviation in Control group 80

APPENDICES
PAGE
APPENDICES TITLE
NO
A Content validation certificate II
Level requesting opinion and suggestions of
B III-IV
experts to validate tool
C Letter seeking experts for content validity of tool V-VI
D Certificate of training VII
Letter requesting permission to conduct pilot study
E VIII
at Vijay Marie hospital, Khairtabad, Hyderabad
Letter requesting permission to conduct main study
F at Niloufer hospital, Red Hills, Lakdikapul, IX
Hyderabad
G Criteria check list for validation of tool X- XII
H List of experts in the field of medicine XII-XIV
Informed consent form XV-
I
XVIII
J Certificate of editing English XIX
Tool used for the study XX-
K
XXV
Procedure of experimentation XXVI-
L
XXXI
Master Data Sheet XXXII-
M
XXXV
ACKNOWLEDGEMENT
“Let us come before him with thanksgiving.”
Psalms 95:2
My heart overflows with gratitude towards God the Almighty for strengthening,
guiding, and directing me all through my project by imparting the light of his
wisdom and helping me to unearth the knowledge through the study.
Every step I took in my thesis marked the Lord's invisible but palpable
presence. It is my privilege to express my deepest gratitude in thanking all
who have contributed to the successful completion of this endeavour.
This thesis is the fruitful culmination of the valuable guidance and assistance
of several people to whom the investigator recalls there with a grateful heart
and will always be indebted.
My sincere thanks to Rev. Sr. Nirmala. P, Principal and H.O.D, Vijay Marie
College Of Nursing, Begumpet, Hyderabad-for being the pillar of support
throughout my nursing career and enabling me to accomplish this goal. I fall
short of words to express my gratitude to you, Sister, for all you have been to
me.
My humble gratitude and regards to you for being my project guide and for
your guidance, suggestions, timely support, encouragement, and advice
throughout the study.
"Cherish your vision and dreams as they are the children of your soul and
blueprints of your ultimate achievements"- the motto of Rev. Sr. Anne
Ponnattil -Professor, H.O.D of Medical-Surgical Nursing, Vijay Marie College
Of Nursing. Her beauty of spirit & hope for a better future has inspired my
dreams to come true. I am grateful to owe my thanks to you, sister, for
everything you have done for me.
Heartfelt gratitude and respect for my co-guides, Ms. Swetha Gunti. M.Sc.
(N), Associate professor, Child Health Nursing Vijay Marie College of Nursing,
for their constant guidance, encouragement, patience, and motivation that has
been a source of inspiration.
I thank all the faculty of Vijay Marie College of Nursing for their valuable help,
guidance, and contributions. I would also like to express my gratitude to the
non-teaching staff of the college for their support. I thank the experts in the
Medical-Surgical Nursing field for their valuable suggestions and guidance in
validating the tool.
My thanks to the nursing superintendents of Vijay Marie Hospital, Khairtabad,

and Niloufer Hospital, Red Hills, Lakdikapul, Hyderabad. For permitting me to
conduct the pilot and the main study.
I am highly indebted to Mrs. Rani and Mr. Moses for all the technical support
and prayers. A word of special thanks to my friends and classmates for their
timely help and cooperation during the study.
This acknowledgment is incomplete without thanking all the staff nurses

working at Vijay Marie hospital, Khairtabad, Hyderabad, and Niloufer Children
Hospital, Red Hills Lakdikapul, Hyderabad. My heartfelt thanks go to everyone
for their enthusiastic engagement and cooperation during the project.
A special thank you to all my well-wishers and those who have directly or
indirectly helped me with their constant support and encouragement, without
which this endeavor would not have been possible.
A particular thanks to my family members, especially my husband, who

provided me with constant support and encouragement, without which this
project would have been impossible to finish.
“We give thanks to you, O God, we give thanks, for your name is near.
We recount our wonderful deeds."
Psalm 75:1
Ms.KUMBHAM
NIHARIKA
1
INTRODUCTION
“A BABY IS BORN WITH A NEED FOR LOVE AND NEVER OUTGROWS

IT”.
“FRANK AND CLARK”
Pain is a frequent and disagreeable sensation for children and adults. Every
child has a perception of pain. Routine immunizations are the most frequent
painful medical procedure during childhood. Healthcare professionals try to
provide vaccines to infants with a less painful experience at their comfort
level. Skin tapping is one of the methods which keeps the muscles relaxed
and thus reduces pain while administering IM vaccination. The present study
aimed to reduce the pain level of infants who receive the vaccination.[1]
Child survival is a field of public health concerned with reducing child

mortality. Child survival interventions are predesigned to address the most
common causes of child mortality, such as contagious diseases. Among
children under the age of 5 alone, an estimated- 5.6 million children die each
year, mostly from preventable causes. In developing countries, with the
introduction of low-cost immunization child mortality rates related to
contagious diseases abate.[2]
2
The infant mortality rate was an indicator used to monitor progress toward the
Fourth Goal of the Millennium Development Goals. The prevalence of infant
mortality rate globally reported is 4.2 million. In India, it was 37.8 per 1000 live
birth. Diphtheria contributed to 20% of infant deaths, pertuss is contributed to
2% of fatal illness.80% of death occurs globally due to Tetanus among
unvaccinated children.[3]
Vaccinations are the safest and most effective way to prevent illness and
death. Vaccination prevents approximately 2.5 million deaths every year.
However, despite the success of vaccinations in preventing morbidity and
mortality, some countries struggle to maintain high levels of vaccination
updates. For example, In the year 2016 only 69% of Indian children aged 19–
35 months had fully completed a combined series of childhood vaccinations.[4]
The Centres for Disease Control and Prevention recommends vaccinations to

prevent 17 life-threatening diseases; consequently, adherence to the
recommended vaccination schedule means children will receive an average of
18–24 injections by the time they are two (2) years old. Adhering to
vaccination gives protection against so many diseases. Some parents may
delay or refuse childhood vaccinations for a variety of reasons. Few common
parental reasons for refusing childhood vaccinations include questioning
vaccination safety, distrust of the government, and concern about
contraindications.[5]
An intramuscular injection is common, yet a complex technique used to

deliver medication and vaccination deep into the larger muscles in the body.
The intramuscular injection route provides faster drug absorption than the
subcutaneous route because the muscle has greater vascularity. Several
factors influence a person's experience of pain during intramuscular
injection.For example-anxiety, culture, age, gender, and expectation of pain
3
relief. These factors may increase or decrease the perception of pain during
intramuscular injection.[6]
A pain-producing stimulus sends an impulse across a peripheral nerve fiber.

The pain fiber enters the spinal cord and travels one of several routes until
ending within the gray matter of the spinal cord. There the pain message
interacts with inhibitory nerve cells and prevents the pain stimulus from
reaching the brain to the cerebral cortex. Once a pain stimulus reaches the
cerebral cortex, the brain interprets the quality of pain and processes
information about experience, knowledge, and cultural associations in the
perception of pain.[7]
The most appropriate sites for IM injections are the vastus lateralis
(anterolateral thigh) for infants and toddlers and the deltoid muscle for
pediatric patients three (3) years and older. The proper selection of the
injection site depends on the patient's age, muscle mass, medication volume
and viscosity .[8]
Vaccinations in Infants and Children:
The vaccines recommended for routine immunization by the Centers for

Disease Control and Prevention (CDC) in all children from birth through age 6
years are discussed below. [1]
For more detailed information, including
exceptions and other considerations. Unless otherwise stated, the vaccines
listed below are administered via intramuscular (IM) injection. IM
administration in the anterolateral thigh muscle is preferred in neonates,
infants, and small children. IM administered in the deltoid muscle is preferred
in young children (eg, aged 4-6 years) who are normal in weight.[8]
Hepatitis B vaccine (HepB):
4
 Minimum age: Birth
 3 doses
The first dose of monovalent
 HepB before hospital discharge*
 Second dose with monovalent or combination vaccine at age 1 or 2
months
 Third dose at age 6-18 months
 If the mother is HBsAg-positive, also administer hepatitis B immune
globulin (HBIG) 0.5 mL within 12 hours of birth
 If the mother’s HBsAg status is unknown, also administer HBIG to
infants weighing < 2 kg within 12 hours of birth; determine the mother’s
HBsAg status as soon as possible, and, if the mother is HBsAg-
positive, also administer HBIG in infants weighing ≥2 kg as soon as
possible, but no later than age 7 days.
Diphtheria, tetanus, acellular peruses vaccine (DTaP):
 Minimum age: 6 weeks

 Doses at ages 2 months, 4 months, 6 months, and 12-15 months
 Final dose at age 4-6 years
 If the fourth-dose DTaP vaccine was administered 4 months or more
after the third dose, at an appropriate age, it can be counted as valid
and need not be repeated after the recommended 6-month interval
between doses 3 and 4.
Haemophilus influenza type b vaccine (Hib):

 2- or 3-dose primary series and 1 booster dose (dose 3 or 4 depending
on the vaccine used for primary series) at age 12-15 months
 Doses at ages 2 months, 4 months, 6 months (brand dependent), and
a booster at 12-15 months.
5
Pneumococcal vaccine 13-valent (PCV13):

 Doses at ages 2 months, 4 months, 6 months, and 12-15 months
 See the CDC’s full vaccines and immunizations guidelines for updated
(2015) scheduling considerations.
 In 2015, the Advisory Committee on Immunization Practices provided
recommendations on the pneumococcal polysaccharide
vaccine (PPSV23) and the pneumococcal conjugate vaccine (PCV13),
summarized as follows:
 The ACIP currently recommends that an effective dose of PCV13 be
followed by a dose of PPSV23 in persons aged 2 years or older who
are at a higher risk for pneumococcal disease because of underlying
medical conditions.
 Children with an immune-compromising condition or functional or
anatomic asplenia should receive a second dose of PPSV23 5 years
after the first PPSV23 dose.
Inactivated poliovirus vaccine (IPV):

 4 doses administered IM (may administer SC or IM in deltoid in older
children)
 Doses at ages 2 months, 4 months, 6-18 months, and age 4-6 years
 Influenza vaccine minimum age: 6 months for the trivalent inactivated
vaccine (TIV) and the quadrivalent inactivated vaccine (brand
dependent).
 Influenza virus vaccine quadrivalent, intranasal age range: 2 through
49 years
6
The Advisory Committee on Immunization Practices (ACIP) recommended the
return of the intranasal flu vaccine in the United States for the 2018-2019
season based on positive results from a US study in children aged 2 years to
younger than 4 years that evaluated the shedding and antibody responses of
the H1N1 strain in the live attenuated influenza vaccine (LAIV). The study
showed that the new 2017-2018 H1N1 LAIV post-pandemic strain
(A/Slovenia) performed significantly better than the 2015-2016 H1N1 LAIV
post-pandemic strain (A/Bolivia), which was associated with lower
effectiveness and was not recommended during the prior two seasons.
Measles, mumps, and rubella vaccine (MMR):
 Minimum age: 12 months

 Administer by SC into the outer aspect of the arm
 Two-dose series at ages 12-15 months and 4-6 years
Varicella virus vaccine:

 Administer by SC injection into the outer aspect of the upper arm or the
anterolateral thigh
 Two-dose series at ages 12-15 months and 4-6 years
Hepatitis A vaccine (HepA):

 Two-dose series beginning at ages 12-23 months; a second dose is
given 6-18 months later.

The following clinical practice guidelines were released in 2015 by Help
Eliminate Pain in Kids.[8]

 No aspiration should be used during intramuscular vaccine injections in
individuals of all ages.
7
 Inject the most painful vaccine last (rather than first) during vaccine
injections in individuals of all ages.
 Breastfeeding should be used during vaccine injections in children
aged 2 years and younger.
 Holding should be used (rather than the child lying supine) during
vaccine injections in children aged 3 years and younger.
 Sitting upright should be used (rather than the individual lying supine)
during vaccine injections in children aged 3 years and older and adults.
 Apply topical anesthetics before vaccine injections in children aged 12
years and younger.
 Give sucrose solution before vaccine injections in children aged 2
years and younger.
 Educate parents about pain management before the day of vaccination
and on the day of vaccination.
 Educate children aged 3 years and older about pain management on
the day of vaccination.
 Parents should be present during vaccine injections in children aged 10
years and younger.
Injection for vaccination is the most common source of iatrogenic pain in

childhood. It is administered repeatedly to almost all children throughout
infancy, childhood, and adolescence. The pain associated with such injections
is a source of distress for children, their parents, and those administering the
injection. If not addressed, this pain can lead to pre-procedural anxiety in the
future, needle fear, and health care avoidance with vaccination schedules. It
is estimated that up to 25% of adults have a fear of needles, with most fear
developing in childhood. About 10% of the population avoids vaccination and
other needle procedure because of pain.[9]
Innovative Evidenced Based Nursing interventions for minimizing pain during

childhood vaccination can help to prevent distress, development of needle
fear, and subsequent healthcare avoidance behaviours such as non-
8
adherence with the vaccination schedule. A positive experience during
vaccine injection also maintains and promotes trust in healthcare providers.[10]
Helfer Skin Tap Technique is tapping over the intramuscular site with the
palmer aspect of the finger 16 times before and three(3) counts during the
procedure. Skin tapping in the area close to the site of an immunization
injection will activate the A-beta neuron that closes the gate. Transmission of
pain signals arising from the injection site will, therefore, be inhibited at the
level of the spinal cord. The proximity of the tapping and injection site would be
expected to facilitate gating for the appropriate spinal neurons.[11]
NEED FOR THE STUDY
“KINDNESS TO CHILDREN, LOVE FOR CHILDREN, GOODNESS TO

CHILDREN. THESE ARE THE ONLY INVESTMENTS THAT NEVER FAIL.”
HENRY DAVID THOREAU
Pain is a common and existing sensation for children and adults. Every child
has his or her perception of pain.[12] Routine Immunization is the most frequent
painful medical procedure during childhood. The world health organization
estimates that 12 billion injections are given annually, out of which
approximately 5% are childhood vaccination. Vaccine injections are the most
common reason for iatrogenic pain in childhood. With the steadily increasing
number of recommended vaccination, there has been a concomitant increase
in concern regarding the adequacy of pain management.[13]
9
There are twelve billion intra-muscular injections administered annually
throughout the world. Intramuscular injections may be an unpleasant
experience for the child. Pain management throughout any invasive
procedure may be a challenge to the health care delivery systems. Injections
are the most frequently used medical procedure, with an estimated 12 billion
administered throughout the world on an annual basis. A conservative
estimate of the average number of injections ranged from 0.9 to 8.5 per
person per year (Kermode, 2000), with a median of 1.5 injections per person
per year.[14] An estimated 25 million children under the age of 1 year did not
receive vaccines which is the highest number-2009.In 2021, the number of
entirely unvaccinated children increased by 5 million in 2019. In 2021, about
81% of infants worldwide (105 million infants) received the vaccination.[15]
In 2021, 18.2 million infants did not receive an initial dose of the DTP vaccine,
pointing to a lack of access to immunization and other health services, and an
additional 6.8 million were partially vaccinated. Of the 25 million, more than
60% of these children live in 10 countries: Angola, Brazil, the Democratic
Republic of the Congo, Ethiopia, India, Indonesia, Myanmar, Nigeria,
Pakistan, and the Philippines.[15]
A fundamental principle of responsible medical care is not-‘do not hurt’, but

‘do not harm’ since pain is harmful to children, and caregivers are committed
to preventing harm to their patients. [15]
Dr.BindhuMathew (2019) Conducted one group posttest design study The

total sample size was 70 children between 0 to 12 months. Gate control
theory of pain was the conceptual framework adopted and the standardized
FLACC Pain scale was used to assess the pain level of children. Results: The
result reveals that the majority (57%) of children have experienced mild pain
with the technique of Helfer Skin Tap Technique in children. There was no
significant association between the variables under study and the pain score
10
obtained. The study explores a method namely Helfer Skin Tap Technique for
minimizing the pain experienced during vaccination in infants. [17]
G. BHUVANESWARI, (2018) Conducted an experimental study at the

Primary Health Centre at Neamam. The study samples infants who are
receiving vaccinations intra-muscular injection. The total sample size was 60,
and each sample for the control and experimental groups selected a
convenient sampling technique. Each patient was administered repeated
intramuscular injections at Vastus Lateralise. The pain level with the
administration of intramuscular during vaccination injection of traditional
technique was compared with a pain level with Helfer Skin Tapping
Technique. The tool developed and used for the data collection were socio-
demographic variables and assessment, Universal pain scale Neonatal Infant
pain scale (NIPS) was used to assess the level of pain perception. Results:
The pain perception of patients in terms of the pain level of traditional
technique was found to be significantly higher than the pain level of Helfer
skin, tapping Technique, and the experimental group decreased level of pain
and show the significance at the level of P<0.05 in the pooled standard
deviation of the t’s test. Conclusion: The finding of the study help to determine
the effect of Helfer Skin Tap Techniques in reducing pain during intramuscular
injection. This cane is implemented by the health personnel while
administering the injection. Reduction in pain during intra muscular injection
would enhance the case of immunization. [16]
DPT vaccine generates more pain due to the presence of an inactivated

whole-cell component of pertussis. Most Whole cell Pertussis vaccines are
available in combination with diphtheria (D) and tetanus (T) vaccines,
containing aluminum salts as an adjuvant and, thiomersal as a preservative.
Immunization with Whole cell Pertussis vaccines is more effective and
inexpensive than cellular pertussis.[18]
11
Many parents worry about baby shots and fever after vaccines .some believe
there is a link between ingredients in vaccines and autism. Ever since
vaccinations were developed, there have been risks, including the risk of
developing the disease or serious side effects. But most vaccine side effects
are very mild and severe one quite rare. The use of childhood vaccinations
has essentially ended several childhood diseases that otherwise resulted in
hospitalization or death.[15]
Failure to get babies vaccinated can result in new epidemics of diseases that
can be harmful- even deadly. For example, before the measles vaccine, 3 to 4
vaccine people in the united states got measles each year 48000 were
hospitalized and 400 to 500 died annually. Diphtheria
was one of the most common childhood causes of death in school-age
children. About 4 million people got chicken pox each year in the united
states, over 10,500 o those people were hospitalized and about 100 to 150
people died from pertussis, or whooping cough, an illness that makes it
difficult to breathe, killed 8,000 people annually before the vaccine was
developed. [15]
While baby shots are proven to protect children against diseases, there are
also confirmed ways to soothe a newborn or baby after vaccinations. Here are
some shot soothers that work best.Providing pain relief is considered a most
basic human right, so it is the responsibility of the nurse to use the most
effective approach to pain control. Nurses are ethically and legally responsible
for managing pain and relieving suffering. Effective pain management not only
reduces physical discomfort but also improves the quality of life.
A therapeutic procedure like Helfer's skin-tapping techniques can be an

important emotional outlet for the children as they let out feelings that they are
unable to express. Ideally tapping the skin is relaxation of the muscle, so an
12
experienced caregiver can help the child to expose the feeling and explores
strategies for coping with distress. Pain management is one of the main facets
of nursing care, where nurses need to be competent. Pain management
during an invasive procedure is a challenge to direct care providers. Helfer
Skin Tap Technique offers a painless injection experience. In Helfer Skin Tap
Technique rhythmic tapping before injection over the skin at the site of
injection keeps the muscle relaxed and stimulates large diameter fibers.[18]
Helfer Skin Tap Technique, one of these techniques, was developed by nurse
Joanne Kieffer Heifer to reduce pain associated with IM injections. In 1998 Mr.
Joanne Kieffer Heifer attempted to alleviate pain due to IM injections by
developing the Helfer Skin Tap Technique Tapping over the intramuscular
injection site with the palmer aspect of the finger 16 times before and 3 counts
during the administration of IM vaccination to infants and continue the tapping
till needle is removed.
The most challenging role of treatment providers is serving children to

appropriately assess and treat their pain. Finding the study will help to
determine the effect of Helfer Skin Tap Techniques in reducing pain during
intramuscular injection. This can be implemented by the health personnel
while administering an injection. Reduction in pain during vaccination. Infants
undergo many painful procedures in different clinical environments.
The investigator during her clinical experience observed the level of pain
among children during Intramuscular vaccination is being given. So she was
indented to apply this technique.
Considering all the above facts motivated the investigator to conduct this
study to determine the effectiveness of the Helfer Skin Tap Technique on
reducing vaccination pain in infants who are receiving intramuscular
vaccination. [15]
13
STATEMENT OF THE PROBLEM:
A Study to Assess the Effectiveness of Helfer Skin Tap Technique on Pain

Reduction Among Infants During Intramuscular Vaccination at selected
pediatric hospitals, Hyderabad.
OBJECTIVES OF THE STUDY:
1. To assess the level of pain among infants during Intramuscular

Vaccination in the experimental group at selected pediatric hospitals.
2. To assess the level of pain among infants during intramuscular

vaccination in the control group at selected pediatric hospitals.
3. To determine the effectiveness of the Helfer Skin Tap Technique

among Infants during Intramuscular vaccination in reducing pain in the
experimental group.
4. To compare the level of pain among infants during Intramuscular

vaccination after receiving Helfer Skin Tap Technique in the
experimental and control group.
5. To find out the association between post-test levels of pain among

infants during intramuscular vaccination with the Helfer Skin Tap
Technique with their selected demographic variables.
OPERATIONAL DEFINITION:
14
ASSESS:
To examine for evaluation and/or quality improvement.
In this study, an assessment is used to see the Effectiveness Helfer Skin Tap
Technique on pain reduction among infants during intramuscular vaccination.
EFFECTIVENESS:
A change is a result or consequence of an action or other cause.
In this study, the Helfer Skin Taps Technique is used to see the effectiveness
among infants during intramuscular vaccination.
HELFER SKIN TAPS TECHNIQUE:
In this study, Tap over the intramuscular injection site with the palmer aspect
of the finger 16 times before and 3 counts among infants during the
administration of intramuscular vaccination and continue the tapping till the
needle is removed.
PAIN:
Pain is an unpleasant sensory and Emotional Experience associated with

actual or potential tissue damage.
In this study, It refers to the behavioral expression of an infant during and after
intramuscular vaccination as measured by the FLACC pain scale by the
investigator.
15
INTRA MUSCULAR VACCINE:
In this study, Intramuscular injections are a common yet complex technique

used to deliver medication deep into the large muscles of the body
Infants who are receiving Intramuscular vaccination at Vastus Lateralis.
INFANTS:
In this study,It is considered to designate the human young from birth to 12

months. Refers to the infant in the age group between 1 month and -12
months who are given intramuscular vaccination at Vastus Lateralise at the
selected pediatric hospital.
RESEARCH HYPOTHESIS:
H1: There will be a significant difference in the reduction of pain during

intramuscular vaccination among infants receiving Helfer Skin Tap Technique
in the experimental group.
H2: There will be a significant association between the effectiveness of the

Helfer Skin Tap Technique in pain reduction among infants with their selected
demographic variables.
RESEARCH VARIABLE:
16
A variable represents a measurable attribute that changes or varies across
the experiment whether comparing results between multiple groups, multiple
people, or even when using a single person in an experiment conducted over
time.
Dependent variables:
Level of pain among infants during intramuscular vaccination.

Independent variables:
Helfer Skin Tap Techniqueamong infants during intramuscular vaccination.
DEMOGRAPHIC VARIABLES:
The characteristics and attributes of the study subjects are:
 Developmental stage
 Gender of the baby
 Weight of the baby
 Education status of the father
 Education status of the mother
 Occupation of the father
 Occupation of the mother
 Type of delivery
 Frequency of IM vaccination
ASSUMPTION:
The study assumes that:

 Infants who are selected for the study will have a decrease in the level
of pain during vaccination with the Helfer Skin Tap Technique.
 Helfer Skin Tap Techniquewill help decrease pain among infants during
intramuscular vaccination.
17
 Helfer Skin Tap Techniquemay be accepted as an intervention for
reducing pain among infants during intramuscular vaccination.FLACC
pain scale will be effective in assessing the level of pain in infants.
DELIMITATIONS:
The study is delimited to:
1. Infants who are between the age1 month to 12 months old.

2. Infants who are given intramuscular vaccination at the Vastus Lateralis site.
CONCEPTUAL FRAMEWORK OF THE STUDY:
A conceptual framework is the conceptual underpinning of the study. It is a

group o concepts and a set of proportions that spells out the relationship
between them.A conceptual framework is used in research to outline possible
courses of action or to present a preferred approach to an idea or thought. It
can act like maps that give coherence to empirical inquiry. Because
conceptual frameworks are potentially so dose to empirical inquiry, they take
different forms depending upon the research question or problem, a
Conceptual framework is a group of concepts that are broadly defined and
systematically organized to provide a focus, a rationale, and a tool for
integration and interpretation of information.
“Conceptual framework represents a less formal attempt at organizing

phenomenon than theory and deals abstractions that are assembled by the
relevance to common theme”. [19]
Polit and Hungle, 2003.
18
“A conceptual framework can be defined as a set of concepts those
assumptions that integrated them into a meaningful configuration.” [20]
Fawcett, 1980.
The development of a conceptual framework is a fundamental process

required for conducting actual research because it guides each stage.
The study aimed to assess the effectiveness of A Study to Assess the
Effectiveness of the Helfer Skin Tap Techniqueon Pain Reduction Among
Infants During Intramuscular Vaccination at selected hospitals. Hyderabad.
The conceptual framework for this study was derived from the Gate Control
Theory of pain.
GATE CONTROL THEORY OF PAIN:
Helfer Skin Tap Techniqueon Pain Reduction Among Infants During

Intramuscular Vaccination. by reducing the pain response in 1965, Meizack
and Wall introduced the Gate Control Theory of pain, which is still the
dominant theory accepted today (Melzack& Wall, 1965). [21]
APPLICATION OF GATE CONTROL THEORY OF PAIN:
Gate Control Theory of pain: The Gate Control Theory provides a Multi-
dimensional understanding of the complex phenomenon of pain and multiple
influences. Meizack and Wall proposed that the pain signal is transmitted from
the peripheral nervous system to the central nervous system in the central
nervous system the signal to modulated by a gating system in the dorsal horn
of the spinal cord before it reaches the brain, thus, the pain perception can be
increased or decreased depending on influences on the gating system.
19
Stimulation of pain receptors: venous procedures stimulate pain receptors
in the control group there are more stimulations of pales receptors due to
disruption in the continuity of the skin during an intravenous procedure in the
experimental group the is less stimulation of free nerve endings because of
Helfer Skin tap Technique.
Traveling of pain impulses: In the control group pain impulses will be

conducted straight away by A δ and c fibers, which reach the gate of pain and
open the gate, In an experimental group where the infants receive Helfer Skin
Tap Techniquein pulse conducted by fast conducting A & β large fibers which
reach the gate of pain very quickly.
Gating mechanism: Pain impulses, during the intravenous procedure, are

varied through the spinal nerve, which travels through A δ and c fibers, small
diameter and slows conducting myelinated fibers and reach the pain gate and
open the gate us the infants perceive pain Impulses due to Helfer Skin Tap
Technique through fast conducting myelinated A β fibers which superimpose
small fibers and close the pain, and also β endorphin which is released from
interneuron's at spinal cord level which also close the gate of pain thus infants
perceive less pain
20
Stimulation of
Stimulation of Stimulation of
IV Procedure Intervention
Pain receptors
Pain receptors Pain receptors
Selected Variables
 Development
al stage
 Gender of the Gate is Opened Gate
baby
 Weight of the is Closed
baby Less Stimulation Less Pain
Experimental Group Infants receiving Perception
 Education Helfer Skin Tap Free Nerve Ending
Technique
status of the
father
 Education
status of the
mother IV Procedure
 Occupation
of the father
Infants not More Stimulation
 Occupation More Pain
receiving Helfer
Free Nerve Perception
of the mother Control Group Skin Tap
Technique Ending
 Type of
delivery
 Frequency of Gate is opened Gate is Opened
IM
Fig 1: CONCEPTUAL FRAMEWORK ACCORDING TO (WALL AND MALZACK’S GATE CONTROL) APPLIED ON
INFANTS FOR PAIN DURING INTRAMUSCULAR VACCINATION
20
EPILOGUE:
This chapter deals with the need for the study of the Effectiveness of Helfer
Skin Tap Technique on Pain Reduction Among Infants During Intramuscular
Vaccination, Statement of the Problem, Objectives of the study, Operational
Definitions, Assumptions, Variables, Delimitations, Hypothesis, and
Conceptual Framework of the study.
21
22
CHAPTER-2
REVIEW OF LITERATURE
The term “review of the literature” refers to the initial summary of research on
a topic of interest often prepared to put a research problem in context or as
the basis for an implementation project. A review of the literature is a key step
in the research process. [22]
It refers to the process in which the investigator or
reader examined the strength and witness of the appropriate scholarly
publication for literature.[23]
The literature review is based on an extensive survey of books, journals, and

international Nursing indicates. It provides the basis for future investigation,
justifies the need for the study reveals constraints of data collection, and
establishes a comprehensive study of scientific knowledge in a professional
discipline, and from which valid theories may be developed.[22]
The related studies are presented under the following headings:

1. Studies related to pain experienced by infants during immunization.
(10)
2. Studies related to Helfer Skin Tap Technique in reducing pain among
infants during Intramuscular vaccination. (10)
3. Studies related to the effectiveness of various interventions on the
reduction of pain among Infants during intramuscular vaccination. (10)
23
SECTION I-STUDIES RELATED TO PAIN EXPERIENCED BY AN INFANT
DURING IMMUNIZATION:
Dr.Bindhu Mathew (2019) Conducted one group post-test design study The
theory of pain was the conceptual framework adopted, and the standardized
obtained. The study explores a method, namely Helfer Skin Tap Technique-
minimizing the pain experienced during vaccination in infants.[17]
G. BHUVANESWARI, (2018) Conducted an experimental study in Primary

Health Centre at Neamam. The study samples infants who are receiving
vaccinations intra-muscular injection. The total sample size was 60, and each
sample for the control and experimental groups was selected as a convenient
sampling technique. Each patient was administered repeated intramuscular
injections at Vastus Lateralise. The pain level with the administration of
intramuscular during vaccination injection by traditional technique was
compared with a pain level with Helfer Skin Tapping Technique. The tool
developed and used for the data collection were socio-demographic variables
and assessment, Universal pain scale Neonatal Infant pain scale (NIPS) was
used to assess the level of pain perception. Results: The pain perception of
patients in terms of the pain level of traditional technique was found to be
significantly higher than the pain level of Helfer skin, tapping Technique, and
the experimental group decreased level of pain and show the significance at
the level of P<0.05 in the pooled standard deviation of the t’s test. Conclusion:
The findings of the study help to determine the effect of Helfer Skin Tap
Techniques in reducing pain during intramuscular injection. This cane is
24
implemented by the health personnel while administering the injection.
Reduction in pain during intramuscular injection would enhance the case of
immunization. [16]
Therese A Mary (2018) Conducted an experimental study that analyzed the

efficacy of HST vs routine technique on the reduction of pain, in patients who
were administered IM injection in a government general hospital, in
Puducherry. A simple random sampling technique (lottery method) was used,
wherein, 25 subjects were first administered IM injection using HST followed
by routine technique. In the study, the pain level endured by subjects was
examined concerning four variables, i.e., pain, systolic and diastolic blood
pressure, and pulse rate. The result showed that the perception of pain
intensity was less when the IM injection was administered using Helfer Skin
Tap Technique when compared with the routine technique, thereby
concluding that the skin tapping method can be implemented during the
administration of an intramuscular injection. [24]
Sr. Serena (2018) Conducted a quasi-experimental study to assess the effect

of rhythmic skin tapping technique to reduce procedural pain during IM
injections in St. John Medical College Hospital, Bangalore. The result showed
that the skin rhythmic tapping technique is an effective method in reducing
pain during IM injections, as one-third of the patient had no pain with IM
administration. [25]
Sivapriya(2018) Conducted an experimental study that assessed the pain

level endured by neonates during the administration of IM injection, along with
performing the Helfer Skin Tap Technique. They concluded that a significant
decrease was observed in the pain score on the administration of IM injection
with the Helfer Skin Tap Technique(p < 0.05) and control and experimental
group. [26]
25
Vathani G, Kumari. M. J, (2017) Conducted a randomized controlled trial in
JIPMER, Puducherry to assess the effectiveness of the Helfer Skin Tap
Techniqueon pain reduction among the patients receiving an intramuscular
injection. The patients who were getting analgesics and intramuscular
injections in OPD, casualty, and trauma wards and both men and women
between the age group of 21-60 years were selected as samples. The
purposive sampling technique was used to select the patient and the simple
random sampling technique was used to allocate 67 patients each in the
experimental group and control group. The level of pain was measured by
using Numerical Pain Rating Scale. The study findings revealed that there
was an effective pain reduction among patients who received Helfer Skin Tap
Techniquethan the routine group (M±SD= 0.67±1.17 at p<0.001). [27]
Taddio (2016) Conducted a Descriptive study at a child health center in

Canada to find the pain response among 100 children (3-15yrs) during
intramuscular vaccination. The result revealed that the two third of children
(M±SD=6.1±2.9) and one-quarter of adolescents acknowledged some degree
of needle fear (M±SD=4.34±1.78). Furthermore, 5% of parents reported
avoiding or delaying their child’s immunization due to their child’s needle fear.
Parents trusted information provided by physicians, making family physicians
an important source of information for pain management. [28]
Mukash K (2016) Conducted in Canada to assess the pain response of

infants during immunization using a slow standard of care injection versus
rapid pragmatic technique among 113 infants(4-6 months). The intervention
given for the slow standard of care group is slow aspiration before injection
and then slow withdrawal. In the pragmatic group, no aspiration was done,
and rapidly inject the vaccine and withdraw the needle. Immediately infant
26
pain was measured by the modified behavior pain scale (MBPS) and visual
analog scale. The study result reveals that the mean MBPS score was higher
for the standard group. (M±SD=6.21±2.7) compared to the pragmatic group
(M±SD=4.61±2. .45,t=7.8,p<0.001). [29]
Johnston Celeste C, Mary Ellen, (2016) Conducted an observational study

to assess the Acute pain response in infants in the multidimensional
description in Adelaide, Australia. Fourteen infants who were undergoing
routine immunization were studied from a multidimensional perspective. The
measures of data observed were heart rate, crying, body movement,
posturing and voice spectrograph, and pain level measured by the visual
analog scale. There was wide variability between infants on the measures,
especially on the cry spectrographs, although facial expression was
consistent across infants. The study result shows that initially, the heart rate
dropped (90 beats/min), a long, high-pitched cry followed by a sharp increase
in heart rate (160 beats/min). Low-pitched, but dysphonated cries, less body
rigidity, but still facial expression were of pain. Finally, in the second half of
the minute response, heart rate remind elevated(170 beats/min), cries were
lower pitched, more rhythmic, with a rising-falling pattern, and mostly
phonated, and body posturing returned to normal. It suggested that facial
expression may be consistent across- infant indicators of pain
(M±SD=7.4±3.1). [30]
Celeblugiea A, et al., (2015) Conducted an experimental study in Turkey to

compare the pain response of children who receive intramuscular vaccination
(IM vaccination in deltoid muscle versus the pain response of those who
receive IM vaccination in the vastus lateralis). A total of 185 infants were
randomly assigned to one of the two study groups. The deltoid group and the
vastus lateralis group were vaccinated respectively in the deltoid muscle and
the vastus lateralis. The result indicated that the pain response of infants was
similar in each group. The crying duration of children who received the vastus
27
lateralis(M±SD=3.56±1.95) vaccination was shorter than that of the deltoid
group (M±SD=5.6±1.93) procedure. [31]
Piira T, Champion-D, and Bustos T,(2014) Conducted an observational

study in Australia to determine infant pain response during immunization
injection and the proximal influences of parental and nurse coping statements
within the treatment. Pain responses in 93 infants receiving an immunization
injection were video recorded and coded using the Neonatal Facial coding
System recorded. Parent and nurse vocalization was recorded using the
Child-Adult medical procedure interaction Scale. A Multiple regression
analysis evaluated the influences on NFCS scores and found a parental
coping-promoting statement in the 30 seconds before the injection to have a
moderate effect on facial pain response (M±SD=5.64±2.6) during
immunization, infants had the strongest facial pain effect(M±SD=7.64±3.6)The
finding suggests that parental behavior in the treatment room has a key role in
influencing how infants respond to painful procedure (t=6.7, p<0.05). [32]
Patricia C. Parkin,(2014) Conducted an experimental study to determine the

order of vaccine Injection and Infant Pain Response in an outpatient pediatric
clinic in Toronto, Ontario, Canada. A randomized clinical trial was properly
used. A total of 120 infants participated and received the DPTaP-Hib vaccine
first, and 60 received the PCV first. Infant characteristics did not differ
between groups. Overall mean (SD) pain scores per infant after receiving both
vaccine injections were significantly lower when DPTaP-Hib was administered
first compared with when PCV was administered first (MBPS score, 7.6 [1.5]
vs 8.2 [1.5], P=.037; parent VAS score, 4.2 [2.3] vs 5.6 [2.6], P=.003). When
given first, the DPTaP-Hib vaccine caused significantly less pain (P<0.001)
than the PCV, as assessed by the MBPS, VAS, and crying.[33]
28
SECTION II-STUDIES RELATED TO HELFER SKIN TAP TECHNIQUEIN
REDUCING PAIN DURING INTRAMUSCULAR VACCINATION:
Maj Sivapriya and Col Leena Kumari, (2015) Conducted a true

experimental study at tertiary care hospital in Lucknow among 100 newborn
babies. The purposive Sampling technique was used to select the eligible
population and simple random is used to allocate the subject into the
experimental and control group. The neonatal Infant Pain scale (NIPS) was
used to assess the pain level of the newborn. The collected data was
analyzed using descriptive and inferential statistics. A study finding high light
that 86% of neonates in the experiment had mild pain, and only 14%
perceived moderate pain during the IM injection by using the Helfer Skin Tap
Technique. Neonates in the control group (86%) had severe pain, and only
14% perceived moderate pain during IM injection by using the routine
technique. There is a significant decrease in pain score between the
administration of IM injection with the Helfer Skin Tap Technique(z=4.003 at
P<0.05). This study explored the effect of the Helfer Skin Tap Techniqueon
the skin before and during IM injection for pain reduction. [34]
Maria Therese1 and Suriya Devi, (2015) Conducted an experimental study

to assess the effectiveness of the Helfer Skin Tap Techniqueand routine
technique on pain reduction among infants receiving the intramuscular
injection at Government General Hospital, Puducherry by simple random
sampling technique (lottery method), 25 infants were first assigned for
intramuscular injection using Helfer Skin Tap Techniqueand other 25 Infants
were first assigned for intramuscular injection using without Technique. . It
was indicated that the perception of pain intensity is less when an
intramuscular injection is administered using Helfer Skin Tap Technique(t=4.9,
p<0.05). [35]
29
Jose, Rose Mary, (2013), conducted a true experimental study at Manipal
college of nursing, to determine the skin tap technique in pain reduction
during the DPT vaccination. A post-test-only control group design was
adopted for the study. A purposive sampling technique was used to select the
sample. random allocation of treatment using the chit method non-
replacement technique. The sample size was sixty; thirty each in the
experimental and control group. The study revealed that 24(80%) infants had
mild pain responses in the experimental group whereas only 84% of the
control group experienced moderate and severe pain. There was a significant
difference (t=7.14 at p<0.001) in the level of pain between the experimental &
control group. [36]
Toddio A, et al., (2014) Conducted a quasi-experimental study in Canada to

determine the effectiveness of physical intervention in reducing pain during
intramuscular injection among 66 children (6-18 yrs age) who participated in
this study. The method used was tapping the skin close to the injection site
before and during the injection. The result revealed that there is a significant
reduction of pain before (M±SD=2.5±0.7) and during vaccine administration
(M±SD=1.5±0.53, P=0.03). The findings of the study suggest that the
relaxation of muscles will help in reducing injection pain (t=4.2, p<0.01). [13]
Taddio A, and Goldbach M, (2014), conducted a randomized controlled trial

was undertaken to assess the effects of age, gender, and holding on pain
response during infant immunization in a pediatric health center, in Canada.
Infants aged 2 to 6 months have been positioned either supine (SUP) on the
examination table or held (HLD) by a parent during routine immunization in a
community pediatric office. There was no difference between the SUP
(M±SD=4.16±1.9) and HLD(M±SD=4.15±1.89) infants in the duration of
crying, facial grimacing, or visual analog scale (VAS) pain scores. Similarly,
gender did not affect pain response. In contrast, 2-month-old infants displayed
more pain during immunization than did 4 or 6-month-old infants.[13]
30
.
Happens. A and Mc Grathp,(2012) Conducted a meta-analysis was done to
evaluate the effectiveness of physical and procedural interventions for
reducing pain and related outcomes during vaccination. A total of 31 studies
were analyzed. This study result concluded that acute infant distress was
diminished during intramuscular injection without aspiration (n=313). Injecting
the most painful vaccine last during vaccinations reduced acute infant distress
(n=196). Simultaneous injections reduced acute infant 19 distress compared
with sequential injections (n=172). Less infant distress during the acute and
recovery phases combined occurred with vastus lateralis vs deltoid injections
(n=185). Skin-to-skin contact in neonates (n=736) reduced acute distress.
Skin tapping near the injection site before and during vaccination reduced the
infant's acute distress (n=107). Holding after vaccination (n=417) reduced
infant distress during the acute and recovery phases combined. Self-reported
fear was reduced for children positioned upright (n=107). Non-nutritive
sucking (n=186) reduced acute distress in infants. [38]
Saleena Shah, Asha Narayanan, (2012) Conducted a quasi-experimental

study to assess the effect of the Helfer rhythmic skin tap technique on
procedural pain among patients receiving the intramuscular injection at
orthopaedic wards in Govt. Medical College Kozhikode, Kerala. A total of 82
patients were selected in the age group between 20-30 years, who were
receiving Inj. voveran. A simple random sampling technique was used to
allocate the patient to intervention and routine groups. The patient pain level
was measured by using Numerical Pain Intensity Scale and Visual Analogue
scale. Data were analyzed by SPSS. The study result reveals that there was a
significant reduction in pain perception of patients receiving IM injections with
the Helfer Rhythmic skin tap technique(t=25.5,p<0.01). [39].
31
Swathi John (2018) ,conducted an experimental group study to assess the
Helfer tap technique on infants. The skin was tapped rhythmically with the
middle, ring, and little finger of the dominant hand counting one to 16 times. It
was found to be effective in reducing pain (p < 0.05) as compared with routine
treatment. [40].
Amira Ahmad(2018) conducted a quasi-experimental and only analyzed the

efficacy of HST on pain intensity as perceived by the patient receiving IM
Injection. A quasi-experimental research design was used where 100 patients
were collected by purposing sampling technique and conducted at medical
and surgical units at Main Mansoura University Hospital. Each patient was
administered repeated IM injections at the gluteal site. The results showed
that the pain perception of patients in terms of the pain level of the traditional
technique was found to be significantly higher than the pain level of the Helfer
skin tapping Technique and thereby concluding that the Skin tapping
technique was effective in reducing the pain level of patients. [41]
SECTION III-STUDIES RELATED TO THE EFFECTIVENESS OF VARIOUS

INTERVENTIONS ON REDUCTION OF AMONG INFANTS DURING
INTRAMUSCULAR VACCINATION PAIN.
Romanò CL, and Cecca E, (2015), Conducted an experimental study to

determine the effectiveness of tactile stimulation on pinprick pain among
infants during immunization in the primary health centre in Mumbai. The pain
level was measured by the Modified Behavioral Pain Scale (MBPS). A total of
212 infants receiving DTaP-IPV-Hib and PCV immunization were randomly
assigned to two groups of 106 patients each. During the injection procedure,
multiple blunt plastic pins are pressed onto the skin at the injection site before
and during the penetration of the injection needle into the skin. There was a
significant reduction of pain in the treatment group compared with the control
32
group after immunization (Modified Behavioural Pain Scale (MBPS):
(5.16±1.37 v/s 1.90±1.27). This study explored the effect of tactile stimulation
over the skin on pain reduction during immunization. [31]
Michel J. R & Whitney F. W,(2014) Conducted an experimental study to

know the effectiveness of applying manual pressure to reduce pain during
intramuscular injection in a child health center in Haryana. A total of 212
children aged 4-6 yrs participated in the study. The first group was given an
injection in a conventional way that is without manual pressure being applied
before the injection. The second group was given an injection with manual
pressure applied before the injection for each sample. The samples with
manual pressure applied before injections reported Lower pain
(M±SD=1.32±0.77) intensity scores, while those without the application of
manual pressure before injections reported higher pain intensity scores
(M±SD=6.7±2.6). Study finding shows that applying manual pressure to an
injection site before performing an injection could be an effective means of
decreasing pain intensity. [42]
Sparks L, (2014), was conducted a randomized study of 105 children aged 4

to 6 years undergoing immunization with diphtheria-tetanus-pertussis (DTP)
who were randomized to one of three treatments: light stroking of the skin
near the injection site, bubble blowing by the child, or standard care. The pain
was measured with the 10-point self-report voucher scale. No statistical
difference was found between light stroking and bubble blowing, although
numerically less pain was reported in the light stroking group (1.89 versus
2.00). Both treatments together resulted in less pain than the control group
(2.89,p = 0.013). The study findings depict that distraction makes the child to
be engaged, the group receiving light touch may have been at an advantage
because the intervention did not require the child to attend to the activity. [9]
33
Manal Abuelkheir,(2014), was conducted a randomized control trial was
done to evaluate the effectiveness of a topical eutectic mixture of local
anesthetic (EMLA) cream in reducing the pain associated with vaccination
injections. Eligible children were randomly assigned to receive either EMLA or
placebo cream. The Modified Behavioral Pain Scale (MBPS) was used to
assess baseline and post-vaccination pain scores, while a visual analog scale
(VAS) was used to assess pain at the time of the needle prick and the end of
the injection. A total of 107 children were enrolled in the EMLA group and 109
children in the placebo group. The difference between the pre-and post-
vaccination MBPS scores was significantly lower in the EMLA group than in
the placebo group (2.56-1.96 versus 3.95-2.20). The VAS scores at the time
of the needle prick and after the injection were significantly lower in the EMLA
group compared with the placebo group (1.60-1.67 versus 3.24-2.01; 3.29-
2.27 versus 4.86-2.20). The study results show that the application of EMLA
cream can be effectively incorporated as a routine pain-relieving intervention
during routine vaccination. [43]
Mitra SavabiEsfahani, (2014), was conducted a randomized clinical trial was

conducted among ninety-six infants. The sample was allocated randomly to
three groups (breastfeeding, massage, and control groups). The study
population comprised all infants, accompanied by their mothers to health
centres in Isfahan for vaccination of hepatitis B and DPT at 6 months of age
and MMR at 12 months of age. Data was gathered using a questionnaire and
checklist [neonatal infant pain scale (NIPS)]. the study showed that the three
groups had no statistically significant difference in terms of demographic
characteristics like age, gender, and weight (P > 0.05). The mean pain scores
in the breastfeeding group, massage therapy, and control group were 3.4, 3.9,
and 4.8 (P < 0.05). Differences between the group, massage therapy and
breastfeeding (P = 0.041), breastfeeding group and control (P = 0.001), and
massage therapy and control groups (P = 0.002) were statistically significant.
The results of the study denote that breastfeeding during vaccination has
more analgesic effects than massage therapy. [44]
34
Gitanjali Zore, and Regina Dias, (2014), conducted an experimental, one-
group pre-test and the post-test study was conducted in J. Hospital Mumbai to
evaluate the effectiveness of manual pressure application & muscle relaxation
therapy on intramuscular injection. Fifty patients in the age group of 15 - 55
years who receive IM injection benzathine penicillin in cardiology OPD were
selected by non-probability convenient sampling technique. The study finding
shows that manual pressure is effective in the management of pain. In the
pre-test, most 39(78%) subjects had a moderate response followed by
11(22%) subjects with a severe response none of the subjects were in no or
mild response. The post-intervention score revealed that 47(94%) subjects
were in mild responses. [45]
(Chung JW, Ng WM, Wong TK, 2013) Conducted a randomized control trial
was performed to determine the effect of the application of Manual pressure
over the injection site on pain. 74 participants between 18 to 20 years of age
were participating in an immunization vaccination campaign. The left and right
arms of the participants were randomized to receive an intramuscular injection
of the hepatitis B vaccine with and without the application of pressure at the
injection site. A mechanical pressure detection device was placed between
the participant’s arm and the investigator’s thumb. Manual pressure was
applied in a standardized way to the deltoid region of the participant’s arm for
10 seconds before the delivery of the vaccination. Pain intensity is measured
by the 10-point pain intensity verbal rating scale. The mean pain score was
lower (M±SD=2.3±0.90) among patients who received manual pressure
before injection. The mean score was higher for perceived pain intensity for
both control conditions (M±SD=6.1±2.1,p<0.001). [46]
Vathani G et (2018) conducted an experimental study to assess the

effectiveness of HST on pain reduction among patients receiving
intramuscular injection, Tramadol, by using an experimental approach. A
simple random sampling technique was used. The findings of the study
35
revealed that among 134 patients, the post-test pain score in the study group
and control group (0.67±1.17 vs. 4.95±1.77) were found to be statistically
highly significant at p<0.010). [27].
Serena, (2010) conducted a quasi-experimental study (one group pre-test

and post-test design) was conducted on 60 patients in Karnataka, India to
assess the effectiveness of the Helfer Skin Tap Techniqueon pain concerning
intramuscular injection. The study revealed that the unpaired t-test was
significant at p < 0.001. the present study also revealed that the effectiveness
of the Helfer Skin Tap Techniquehas produced a statistically highly significant
in reducing pain during intramuscular injection among infants at a correlation
of p<0.05. [25].
Shimmy, (2010) conducted a randomized control trial in Chandigarh to

assess the skin tap technique on pain during intramuscular injection among
adult patients receiving an intramuscular analgesic injection. It was observed
that the mean pain score of the control group was 2.94±1.68 and the
experimental group was 2.08±1.26. The difference t-4 at df – 198 was
statistically significant (p<0.05). It was concluded that perception of pain
intensity is less when intramuscular injections are administered using the skin
tap technique. In this study, it was found that the perception of pain intensity is
less when intramuscular injections are administered using Helfer Skin Tap
Technique rather than a routine technique. [47].
36
37
CHAPTER III
RESEARCH METHODOLOGY
This chapter on research methodology deals with the description of the

research approach, research design, setting, population, sample, and
sampling technique, inclusion and exclusion criteria for sampling development
and description of the intervention, the procedure for data collection, plan for
data analysis an ethical consideration, problems faced during data collection.
This chapter also deals with the description and various steps adopted to
collect and organize data for the study. Research methodology is a systematic
way to solve the research problem. "Research methodology defines the way
pertinent information is gathered to answer the question or analyze" [48]
Polit &Hungle1995.
The research methodology enables the researcher to project a blueprint for

the research undertaken. It is considered the backbone or structure of the
study. The methodology is a systematic theoretical analysis of the methods
applied to a field of study. The selection of research design is an important
step in research as it is closely related to the overall framework for conducting
the study. This gives the investigator the structure and strategy of
investigation.
The problem under study was to assess the effectiveness of the Helfer Skin
Tap Technique on pain reduction during intra-muscular vaccination among
infants in selected pediatric hospitals, in Hyderabad.
38
This chapter includes the research approach, research design, the setting of
the study, variables, population, sample size, sampling technique, sample
collection, development and description of the tool, validity, pilot study, data
collection procedure, inclusion and exclusion criteria for sampling and ethical
considerations, problems faced during data collection. This chapter also deals
with a plan for data analysis, description, and various steps adopted to collect
and organize data for the study.
RESEARCH APPROACH:
The selection of research is the basic procedure for research inquiry. The
research approach helps the researcher to determine what data to collect and
how to analyze it. It also suggests a possible conclusion to be drawn from the
data. Research approaches are plans and procedures for research that span
the steps from broad assumptions to detailed methods of data collection,
analysis, and interpretation. Three research approaches are advanced: (a)
qualitative, (b) quantitative, and (c) mixed method. The investigator chose the
“Quantitative Approach” based on the problem and objectives to be
accomplished. In this study, the effectiveness of the Helfer Skin Tap
Techniqueon Pain reduction during Intramuscular Vaccination Among infants.
RESEARCH DESIGN:
The researcher not only selects a qualitative, quantitative, or mixed-methods

study to conduct; the inquirer also decides on a type of study within these
three choices. Research designs are types of inquiry within qualitative,
quantitative, and mixed methods approach that provide specific direction for
procedures in research design.[49]Research Design is the overall plan for
addressing a research question, including specifications for enhancing the
study’s integrity. It is a blueprint for the conduct of the study that maxims
control over factors that could interfere with the desired outcomes of the
study.In this study, the effectiveness of the Helfer Skin Tap Technique on
39
Pain reduction during Intramuscular Vaccination Among infants, the
investigator has selected the True experimental post-test control group
design.
Considering all the above factors and the availability of time for data
collection, the researcher selected the True experimental post-test control
group design in which the effectiveness of the Helfer Skin Tap Technique is
assessed on the experimental and control group.
Research Design Notation:
GROUP INTERVENTION POST-TEST
X O1
Experimental Group
- O2
Control Group
KEY:
E-Experimental group
X- Helfer Skin Tap Technique
C- Control group
O1- Post test
O2- Post test
40
Selected Variables POPULATION
 Developmental Infants age 1month-12months old who came for

stage immunization room
 Gender of the
baby
SAMPLE
 Weight of the baby
 Education status
60 Infants age 1month-12months old
of the father Niloufer Hospital ,Red Hills,Hyderabad

 Education status
of the mother
 Occupation of the TOOL
father MODIFIED FLACC PAIN SCALE
 Occupation of the
mother
 Type of delivery Non probability Convenient Sample Technique
 Frequency of IM
vaccination
Experimental Group Control Group
Manipulation (Helfer Skin No Manipulation

Tap Technique)
Data Collection
FLACC PAIN SCALE
Observations No
Pain Relief
Pain
Findings
Figure 2: Schematic Representation of Research Design
41
RESEARCH VARIABLES:
A variable is defined as an attribute of a person or object that varies, that

takes on different values. These are which vary and which are not constant. It
is the focus of the study that reflects the empirical aspects of the concepts
being studied, the investigator measures the value. [49]
Dependent Variable:
The dependent variable is the effect of the presumed cause of the
independent variable. It is an outcome variable. In this study, the dependent
variable is Intra Muscular Vaccination.
Independent Variable:
An independent variable is that which results in an effect on the dependent
variable. In this study, Helfer Skin Tap Technique is the independent variable.
SETTING OF THE STUDY:
The setting refers to the physical location and condition in which data
collection takes place in the study. The setting is the specific place where data
collection will occur. The investigator selected pediatric hospitals in
Hyderabad. The selected pediatric hospitals for the present study were Vijay
Marie Hospital, Khairtabad, and Niloufer children’s Hospital, Red Hills
Lakdikapul, respectively.The first hospital was Vijay Marie Hospital,
Khairtabad, located at a distance of about 4 km. It is a 200 bedded hospital
with a total of around 80 nurses.The second hospital was Niloufer children’s
Hospital, Red hills, Lakdikapul, which is located at a distance of about 5.6 km
from the institution. It is a 500 bedded hospital with a total of around 200
nurses.The investigator obtained prior permission and conducted the study in
the respective setting.
42
POPULATION:
The population is the aggregation of all the units in which a researcher is
interested. In other words, the population is the set of people or entities to
which the results of the research are to be generalized. [49]
Target Population:
A target population consists of the total number of people or objects which are
meeting the designated set of criteria. It is the aggregate of all the cases with
a certain phenomenon about which the researcher would like to generalize.
[60] In the present study, the target population is infants 1 month to -12
months in selected pediatric hospitals, in Hyderabad.
Accessible Population:
It is an aggregate of cases that conform to designated criteria and are also
accessible to the investigator as a tool of subjects for the study. In the present
study, the accessible population was Infants 1 month -12 months admitted to
Niloufer children’s hospital, Red Hills, Lakdikapul. [49]
SAMPLE AND SAMPLE SIZE:
A smaller part of the population is selected in such a way that the individuals
in the sample represent (as nearly as possible) the characteristics of the
population. It is a subset of a population selected to participate in a research
study.[62]For this study, the sample included infants 1 month and -12 months
from selected pediatric hospitals. The sample size for this study was arbitrarily
decided to be sixty (thirty to be the control group and thirty in the experimental
group) infants 1 month -12 months in selected pediatric hospitals. Factors like
the nature of the study, availability of the sample, time, expense, and
materials needed were considered while deciding the sample size.
43
SAMPLING TECHNIQUE:
Sampling refers to the process of selecting representative units of a

population for study in research. It is the process of selecting a subset of a
population to obtain information regarding a phenomenon in a way that
presents the entire population. [63]
was used for selecting subjects for the
present study. It is a convenient sampling technique procedure in which the
required numbers of sampling units are selected randomly from the
population.
CRITERIA FOR SAMPLE COLLECTION:
In sampling criteria, the researcher specifies the character of the population

under the study by detailing the inclusion and exclusion criteria. Inclusion
criteria are characteristics that each sample element must possess to be
included in the sample. Exclusion criteria are characteristics that could
confound or contaminate the results of the study therefore, such participants
are excluded from the study. [49]
Inclusion criteria:
The study includes:

1. Infants1month -12months age group
2. Infants receiving Intra Muscular vaccination at the vastus lateralis site
Exclusion criteria:
The study excludes:

1. Infants who are receiving other than intra-muscular vaccination
44
2. Infants of the mother who are not willing to give consent to participate
in this study
DEVELOPMENT AND DESCRIPTION OF THE TOOL:
Data collection tools or instruments are the vehicles that could best obtain the
data pertinent to the study at the time adds to the body of knowledge in the
discipline. Tool development is a complex and time-consuming process. It
consists of defining the construct to be measured, formulating the items,
assessing the items for content validity, estimating the reliability, and
conducting a pilot study. [65]
The tool used for the research study was demographic variables, and pain
assessment by using a modified FLACC pain scale to assess the level of pain
intra-muscular vaccination among infants in selected pediatric hospitals. The
tool was prepared after an extensive review of the literature search,
discussion with an expert’s guide, and also based on the experience of the
investigator. The other steps involved in the final preparation of the tool were
the development of criteria, content validation of the tool, pretesting the tool,
reliability testing of the tool, and preparation of the final draft. Pain
Assessment Scale using FLACC pain scale used the initial and final levels of
assessment.
Description of the tool:
POLIT (1999) states data collection is the instrument that measures the
variables of the study accurately and sensitively.
45
DATA COLLECTION INSTRUMENT:
It consists of two sections
SECTION A: DEMOGRAPHIC VARIABLE:
Comprises of questions to select demographic variables. It consists of items

seeking background information that includes the infant's developmental
stage, gender of the baby, the weight of the baby, education of the mother,
education of the father, occupation of the father, occupation of the mother,
type of delivery, and Frequency of vaccine.
SECTION B:
MODIFIED FLACC PAIN SCALE:
FLACC pain scale. The FLACC Scale was Developed by Sandra Merkel,
Voepol-Lewis T., et al., (1997). It consists of characteristics like Face, leg,
Activity, Cry, and consol ability which is measured to assess pain level for
infants between the ages of 6-14 wks. Each criterion was assigned a score of
0,1 or 2. The FLACC pain scale had marked from 0 to 10, where 0 indicates
relaxed and comfortable and 10 indicate severe pain. The interpretation of the
FLACC pain rating scale had a score of 0 (relaxed and comfortable), 1-3 (mild
pain), 4-6 (moderate pain), and 7-10 (severe pain). FLACC scale had an
established inter-rater reliability value of 0.88.
46
SECTION B-MODIFIED FLACC PAIN SCALE:
BEHAVIOUR BEFORE DURING AFTER

FINDING (5MINUTES
1stmi 5thmin 10th
) nute ute min
ute
FACE
(Restful face, neutral expression)

0-Relaxed
(Tight facial muscles, Furrowed brow,
1-Grimace chin, jaw)
LEGS
(No muscular rigidity, occasional

0-Relaxed Random movements of legs)
(Tense, straight arms, rigid and/or rapid
1-Flexed/Extended extension, flexion)
ACTIVITY
0-Lying quietly normal Regular, rhythmic respirations

position, moves easily
1-squirming, shifting back (Head movement, back, and forth,

and forth, tense aggression)
2-Arched, rigid, or jerking Head banging, shivering , breath-holding,

gasping or sharp intake of breaths, severe
splinting.
CRY
0-No cry (Quiet , not crying )
1-Whimper (Mild moaning, intermittent)
2-vigorous crying (loud scream, shrill, continuous)
CONSOLABILITY
O-Content ,relaxed
1- Reassured by touching
,hugging or being talked to
distractible
2- Difficiult to console or Pushing away caregiver, resisting care or

comfort comfort measures
47
INTERPRETATION:
0 – Relaxed and comfortable
1 -3 Mild pain
4 – 6 Moderate pain
7 -10 – Severe pain
CONTENT VALIDITY:
Validity refers to the degree to which an instrument measures what it is

intended to measure. To obtain the content validity of the tool. The tool with
objectives, operational definitions, and criteria was submitted to five nursing
experts and three medical experts in the field of child health nursing. The
experts were requested to check for relevance, adequacy, and
appropriateness in the tool. A few items were modified, and thereby content
validity was ascertained.
RELIABILITY:
According to Polit and Beck (2008) - Reliability refers to the accuracy and
consistency of information obtained in the study.The reliability of an
instrument is the degree of consistency with which it measures the attribute it
is supposed to be measuring. In this study, the correlation coefficient was
computed by using Karl Pearson's split-half method among six. The obtained
value is 1 which indicates that the tool was reliable.
48
PILOT STUDY:
A pilot study is a small-scale version or trial run designed to test the methods
to be used in a larger, more rigorous study, which is sometimes referred to as
the parent study. The purpose of the pilot study was to assess the
practicability, feasibility to plan for the study, and appropriateness of the
statistical analysis of data. [50] For the present study, the investigator
selected “Vijay Marie Hospital, Khairtabad,” which is similar to the study
area.A period of 7 days was allotted for conducting the pilot study.Formal
permission was obtained from the concerned authorities i.e., the Medical
Director, Head of the departments, and Nursing Superintendent, to conduct
the pilot study. It was conducted from 22.7.2022 to 27.7.2022. The
investigator conducted a pilot study on six preterm infants who fulfilled the
inclusion criteria and were chosen by the Simple random sampling technique.
The subjects were selected from pediatric hospitals. The investigator has
obtained consent from the parents about their willingness to allow the Infants
1month – 12 months to undergo Helfer Skin Tap Techniqueand include them
in the studyData analysis was done using descriptive and inferential statistics.
The analysis showed a significant difference regarding in level of pain intra
muscular vaccination infants in selected pediatric hospitals. The study was
found to be feasible and practicable, and the pilot study did not show any
flaws in the research design.
ETHICAL ISSUES:
The study objectives, intervention, and data collection procedures were

approved by the research and ethical committees of the institution. The pilot
and the main study were conducted after obtaining approval from the
authorities of the respective hospitals. The purpose and other details of the
study were explained and consent was obtained from the parents of the study
participants of Vijay Marie Hospital, Khairtabad, and Niloufer children’s
Hospital. Red Hills, Lakdikapul. Assurance was given to the parents of the
49
study subjects about the anonymity and confidentiality of the data collected
from them. Thus, the ethical issues were insured in the study.
DATA COLLECTION PROCEDURE:
Data collection is the gathering of information needed to address the research

problem. The investigator collected data at Vijay Marie Hospital, Khairtabad,
and Niloufer children’s Hospital. Red Hills, Lakadikapul, during a specified
four weeks period. Prior permission from authorities was sought and obtained.
Sixty infants were selected as per the above-mentioned criteria.
The samples were randomly allotted to the control and experimental group by
Simple random sampling technique. The structured questionnaire was
administered to obtain demographic variables. Conduct a pre-test on the first
day to assess the Level of the pain intramuscular vaccination with help of pain
assessment by using a modified FLACC pain scale among both the control
and experimental group. Helfer Skin Tap Technique was applied only for the
experimental group for 1 minute, 5 minutes, and 10 minutes thrice a day. The
control group received routine care at Niloufer children’s hospital. The
alternative day post-test Intramuscular vaccination scores were assessed by
using the pain assessment using a modified PLACC scale for both
experimental and control groups. All the subjects were very cooperative, and
the investigator expressed her gratitude for their cooperation.
PLAN FOR DATA ANALYSIS:
Data analysis is the systematic organization synthesis of research data and

testing research hypotheses by using obtained data. It was planned to
analyze and interpret data with the help of descriptive and inferential statistics.
The data was edited, coded, and entered on an excel sheet. It was analyzed
50
using SPSS version 19, and the probability of led than 0.05 was considered
significant. The data analysis was organized under the following sections:
Section 1:
Frequency and percentage distribution of infants according to their
demographic variables in the experimental group and control group.
Section 2:
Assess the level of pain among infants during intra-muscular vaccination
in the experimental group and control group.
Section 3:
Mean and standard deviation to find out the significant difference between the
level of pain among infants during intramuscular vaccination in the
experimental group and the control group.
Section 4:
Effectiveness of Helfer Skin Tap Technique during intra muscular vaccination
among infants in experimental group and control group.
Section 5:
chi-square value will be computed to find out the association between the
level of pain among infants during intramuscular vaccination with their
selected demographic variable in the experimental group and control group.
EPILOGUE:
This chapter dealt with the research approach, research design, research
variables, setting of the study, population, sample and sample size, sampling
technique, criteria for sample collection, development and description of the
tool, scoring, content validity, reliability, pilot study, ethical issues, and
procedure for data collection and plan for data analysis.
51
52
CHAPTER – IV
ANALYSIS AND INTERPRETATION
Data analysis is the phase of the study that includes classifying, coding, and
tabulating information needed to perform quantitative or qualitative analyses
according to the research design and appropriate to the data. Data analysis
follows a collection of information and precedes its interpretation or
application. It is the categorizing, ordering, manipulating, and summarizing of
the data to obtain answers to research questions. The purpose of the analysis
is to reduce data to an intelligible and interpretable form so that the relations
of research problems can be suited and tested. It also involves the objective
material in possession of the researcher and her subjective reactions and
desire to derive from data the inherent meanings in that relation to the
problem. To avoid making conclusions or interpretations from insufficient or
invalid data, the final analysis must be anticipated in detail, when plans are
being made for collecting, information.
This the chapter deals with the analysis and interpretation of data regarding
the effectiveness of Helfer Skin Tap Technique on pain reduction among
infants during intra muscular vaccination in selected pediatric hospitals. Data
was collected from sixty infants with a standardized tool to assess the level of
pain. Analysis and interpretation were made with the help of descriptive and
inferential statistics to meet the objective of the studies and to test the
hypothesis.
53
The obtained data from the sample was categorized and analyzed according
to the objectives of the study. The data were interred into excel sheets and
analyzed using SPSS 19 version. The results are presented in tables and
figures appropriately.
 To assess the pre-test level of pain among infants during

Intramuscular Vaccination in the experimental and control group.
 To determine the effectiveness of the Helfer Skin Tap Technique
among infants during Intramuscular vaccination in reducing pain in the
experimental group.
 To assess the level of pain among infants during Intramuscular
Vaccination in the experimental and control group.
 To compare the level of pain among infants during Intramuscular
 To find out the association between levels of pain among infants during
intramuscular vaccination with the Helfer Skin Tap Technique with their
selected demographic variable.
ORGANIZATIONOF THE DATA:
The data collected from the infants were tabulated, analysed, interpreted, and
the findings obtained were presented in the form of graphs under sections as
follows:
54
Section1:
Frequency and percentage distribution of infants according to the

demographic variables in the experimental group and control group.
Section2:
Assess the levels of pain among infants during intra-muscular vaccination in

the experimental group and control group.
Section3:
Mean and standard deviation to find out the significant difference between the
level of pain among infants during intra muscular vaccination in the
Section4:
Effectiveness of Helfer Skin Tap Technique among infants during intra-

muscular vaccination in the experimental group and control group.
Section5:
chi - the square value will be computed to find out the association between
the level of pain among infants during intramuscular vaccination with their
55
SECTION I: FREQUENCYAND PERCENTAGE DISTRIBUTION OF
INFANTSACCORDING TO THE DEMOGRAPHIC VARIABLES IN THE
EXPERIMENTAL GROUP AND CONTROL GROUP.
In research, there is a need to know the demographic variable of the study,

since the findings and interpretations are restricted to a particular study only.
The demographic variables of 60 infants in selected pediatric hospitals are
presented in table no 3 in terms of frequency and percentage. Demographic
variables included in the study were: Developmental stage Gender of the
baby, Weight of the baby, Education status of the Father, Education status of
the mother, Occupation of Father, Occupation of Mother, Type of delivery,
Frequency of IM Vaccination.
Table – 1: Frequency and percentage distribution of infants according

to their Developmental stage.
(n=30+30)
CONTROL EXPERIMENTAL
BACKGROUND Percentage Percentage
Frequency Frequency
VARIABLE (%) (%)
1. Developmental stage
a. 1 -6 months 30 100 30 100
b. 7 –1 Year 0 0 0 0
TOTAL 30 100 30 100
Table 1: Shows that the majority of infants in the control group 30(100%) of
infants were between 1 -6 months, , 0(0%), were 7months-1year, whereas, in
the experimental group, 30 (100%) infants were between 1month-6months, 0
(0%) were 7months-1year.
56
DEVELOPMENTAL STAGE
100
P 110 100
E
R 90
C
70
E Control
N
50 Expermental
T
A 0
30
G
E 0
10
1-6 month
7-1 year
Figure 3: Percentage distribution of Infants according to their

developmental age.
57
Table 2: Frequency and percentage distribution of Infants according to
their Gender.
(n=30+30)
GENDER Percentage Percentage
Frequency Frequency
(%) (%)
a. Male 9 30 11 36.7
b. Female 21 70 19 63.3
TOTAL 30 100 30 100
Table 2: Represents that majority of infants in control group 9 (30%) infants

were male and 21 (70%) were female, whereas in experimental group11
(36.7%) infants were male, 19 (63.3%) were female.
58
GENDER
80
70
P 70 63.3
E
60
R
C 50
E 36.7 control
40
N 30 experimental
T 30
A
20
G
E 10
0
MALE FEMALE
Figure 4: Percentage distribution of Infants according to their gender.
59
.
Table 3: Frequency and percentage distribution of infants according to

their weight of the baby.
(n=30+30)
Weight of the Frequency Percentage Frequency Percentag
baby (%) e (%)
a.3.6-4.5kg 26 86.6 4 13.3
b. 4.6-5.5kg 2 6.7 16 53.3
c. 5.6-6.5kg 2 6.7 10 33.4
d. >6.5kg 0 0 0 0
TOTAL 30 100 30 100
Table 3:Depictesthat majority of infants in control group 26 (86.6%) were

3.6-4.5kg,2(6.7%) were 4.6-5.5kg, 2(6.7%)were 5.6-6.5kg. whereas, in the
experimental group 4(13.3%) were3.6-4.5kg, 16(53.3%) were4.6-5.5kg, 10
(33.4%) were 5.6-6.5kg.
60
WEIGHT OF THE BABY
P 86.6
90
E 80
R 70
C 60 53.3
E 50 control
40 33.4
N experimental
T 30
13.3
A 20 6.7 6.7
0 0
10
G 0
E 3.6-4.5kg 4.6-5.5kg 5.6-6.5kg >6.5kg
61
Figure 5: Percentage distribution of Infants according to weight of the
baby.

their educational status of the father.
(n=30+30)
Educational CONTROL EXPERIMENTAL

status of father Frequency Percentage Frequency Percentag
(%) e (%)
a .illiterate 2 6.7 4 13.3
b. Primary 2 6.7 10 33.3
c. Secondary 10 33.3 5 16.7
d. Graduate 16 53.3 11 36.7
TOTAL 30 100 30 100
Table 4: Shows that majority of infants in control group 2 (6.7%) were

illiterate,2 (6.7%) were primary, 10 (33.3%) were secondary,16(53.3%) were
graduate. whereas, in the experimental group 4 (13.3%) were illiterate,
10(33.3%) were primary , 5 (16.7%) were secondary were 11(36.7%)
graduate.
62
EDUCATIONAL STATUS OF FATHER
P 60 53.3
E
R 50
C 36.7
40 33.3 33.3
E control
30
N experimental
16.7
T 20 13.3
A 6.7 6.7
10
G
E 0
illiterate primary secondary graduate

educational status of father
63
.

their educational status of mother.
(n=30+30)
Educational CONTROL EXPERIMENTAL
status of mother
Frequency Percentage Frequency Percenta
(%) ge (%)
a. Illiterate 3 10 4 13.3
b. Primary 10 33.3 10 33.3
c. Secondary 11 36.7 5 16.7

d. Graduate 6 20 11 36.7
TOTAL 30 100 30 100
Table 5:Shows that majority of infants in control group 3 (10%) were

illiterate,10 (33.3%) were primary, 11 (36.3%) were secondary,6(20%)were
graduate. whereas, in the experimental group 4 (13.3%) were illiterate,
10(33.3%) were primary , 5 (16.7%) were secondary were
11(36.7%)graduate.
64
EDUCATIONAL STATUS OF MOTHER
40 36.7 36.7
P 33.333.3
35
E
R 30
C 25 20
E control
20 16.7
N 13.3 experimental
T 15 10
A 10
G
E 5
0
illiterate primary secondary graduate
Figure 7: Percentage distribution of Infants according to their of

educational status of mother.
65
their occupation of father.
(n=30+30)
Occupation of
Father CONTROL EXPERIMENTAL
Frequency Percentage Frequency Percentage
(%) (%)
a. Government 2 6.7 4 13.3
Employee
b. Private 19 63.3 16 53.3
Employee
c. Business 7 23.3 8 26.7
d. Labour 2 6.7 2 6.7
TOTAL 30 100 30 100
Table 6: Shows that majority of infants in control group 2 (6.7%) were

Government Employee,19 (63.3%) were private Employee, 7 (23.3%) were
Business,2(6.7%)were Labour. whereas, in the experimental group 4 (13.3%)
were Government Employee, 16(53.3%) were private Employee , 8 (26.7%)
were Business , 2(6.7%)were Labour.
66
OCCUPATION OF
FATHER
70 63.3
P 60 53.3
E
50
R
C
40
E control
N 26.7
30 experimental
T 23.3
A 20 13.3
G
E 10 6.7 6.7
2.8
0
government private business labour
employee employee

occupation of father.
67
their occupation of mother.
(n=30+30)
Occupation of
Mother CONTROL EXPERIMENTAL
Frequency Percentage Frequency Percentage
(%) (%)
a. Government 2 6.7 1 3.3
Employee
b. Private 10 33.3 11 36.7
Employee
c. Business 8 26.7 9 30
d. Housewife. 10 33.3 9 30
TOTAL 30 100 30 100
Table 7:Shows that in the control group 2 (6.7%) were Government

Employee,10 (33.3%) was private Employee, 8 (26.7%) were
Business,10(33.3%) were Housewife. whereas, in the experimental group 1
(3.3%) were Government Employee, 11(36.7%) were private Employee, 9
(30%) were Business, 9(30%)were Housewife.
68
OCCUPATION OF MOTHER
40
36.7
P 35 33.3 33.3
E 30 30
30 26.7
R
C 25
E
20
N control
T 15 experimental
A 10
6.7
G
3.3
E 5
0
government private business house wife
employee employee

occupation of Mother.
69
their Type of Delivery.
(n=30+30)
Type of Delivery CONTROL EXPERIMENTAL

Frequency Percentage Frequency Percentag
(%) e (%)
Normal 14 46.6 10 33.3
LSCS 12 40 15 50
Vaccum 2 6.7 3 10
Forceps 2 6.7 2 6.7
TOTAL 30 100 30 100
Table 8: shows that majority of infants in control group 14 (46.6%) were

Normal,12 (40%) were LSCS, 2 (6.7%) were Vaccum,2(6.7%)were Forceps.
whereas, in the experimental group 10 (33.3%) were Normal, 15(50%) were
LSCS , 3 (10%) were Vaccum , 2(6.7%)were Forceps.
70
TYPE OF DELIVERY
60
P 50
E 50 46.6
R 40
40
C 33.3
E 30
30 control
N experimental
T 20
A 10
10 6.7 6.7
G
E 0
Normal LSCS Vaccum Forceps
Figure 10: Percentage distribution of Infants according to their Type of

delivery.
71
their Frequency of IM Vaccination.
(n=30+30)
Frequency of IM
Vaccination Percentage Percentage
Frequency Frequency
(%) (%)
a. I Dose 3 10 2 6.7
b. II Dose 21 70 10 33.3
c. III Dose 6 20 18 60
TOTAL 30 100 30 100
Table 9: Shows that majority of infants in control group 3(10%) were I Dose
,21(70%) were II Dose, 6(20%) were III Dose, whereas in the experimental
group 2 (6.7%) were Dose, 10(33.3%) were II Dose, 18(60%) were III Dose.
72
FREQUENCY OF IM VACCINATION
P 60
80 70
E
R
C 60 33.3
E Control
N 40
6.7 20 Experimental
T
20 10
A
G
E 0
I Dose II Dose III Dose
Figure 12: Percentage distribution of infants according to their

Frequency of IM Vaccination.
73
SECTION II: ASSESS LEVEL OF PAIN INTRA MUSCULAR VACCINATION
AMONG INFANTS IN EXPERIMENTAL AND CONTROL GROUP.
Table 10: Frequency and Percentage of intra muscular vaccination
among infants in experimental group
(n = 30)
FLACC Level of pain Experimental group

Pain scale (Before During (after)
5minutes)
1st 5th 10th
minute minute minute
F % f % f % f % f %
0 Relaxed and 27 90 1 3.33 1 3.33 10 33.33 26 86.67
Comfortable
1–3 Mild pain - - 6 20 11 36.67 15 50 4 13.33
4–7 Moderate 2 6.67 19 63.33 18 60 5 16.67 - -

Pain
8 – 10 Severe pain 1 3.33 4 13.33 - - - - -
Table 10: Shows that majority of infants in experimental group 27(90%) infants
were relaxed and comfortable. During vaccination in experimental group
19(63.33%) infants experienced moderate pain. On post assessment at 1st
74
minute in experimental group 18(60%) infants had moderate pain. 5 th after the
vaccination in experimental group 15(50%) infants had mild pain,
10(33.33%)infants relaxed and comfortable. 10th after the vaccination 26(86.6%)
infants were relaxed and comfortable.
LEVEL OF PAIN IN EXPERIMENTAL

GROUP
100
90 86.67
90
P 80
E
70
R 63.33 60
C 60
E 50
50
N
36.67
T 40
33.33
A 30
G 20 16.67
E 20
13.33 13.33
10 6.67
0 3.33 3.33 3.33 0 0 0 0
0
Before(5minutes) During 1 st minute 5th minute 10th minute
Relaxed and comfortable Mild pain Moderate pain Severe pain
75
Figure 12: Percentage distribution level of pain during intra muscular
vaccination among infants in experimental group.
76
Table 11: Frequency and Percentage of intra muscular vaccination
among infants in control group.
(n = 30)
FLACC Level of pain Control group

Pain scale (Before During (after)
5minutes)
1st 5th 10th
F % f % f % f % f %
0 Relaxed and 23 76.67 - - - - - - 6 20
Comfortable
1–3 Mild pain 4 13.33 - - - - 16 53.33 24 80
4–7 Moderate 2 6.67 3 10 18 60 14 46.67 - -

Pain
8 – 10 Severe pain 1 3.33 27 90 12 40 - - - -
Table 11: shows that majority of infants where as in control group23 (76.77%)
infants were relaxed and comfortable. where as in control group most of the
infants 27(90%) experienced severe pain, only 3(10%) infants experienced
moderate pain. where as in control group12(40%) infants had severe pain. where
as in control group 16(53.33%) infants had mild pain&14(46.67%) infants had
moderate pain. where as in control group 6(20%)infants were relaxed and
comfortable and 24(80%)infants experienced mild pain.
77
LEVEL OF PAIN IN CONTROL
100
GROUP
90 90
80
P 80 76.67
E
70
R 60
C 60
53.33
E 46.67
50
N 40
T 40
A
30
G 20
E 20 13.33 10
6.67
10 3.33 0 0 0 0 0 0 0 0
0 Before(5minutes) During 1 st minute 5th minute 10th minute
Relaxed and comfortable Mild pain Moderate pain Severe pain
Figure 13: Percentage distribution level of pain during Intra muscular

vaccination among infants in control group.
78
SECTION III: MEAN AND STANDARD DEVIATION TO FIND OUT SIGNIFICANT DIFFERENCE BETWEEN LEVEL OF
PAIN AMONG INFANTS DURING INTRAMUSCULAR VACCINATION IN EXPERIMENTAL GROUP AND CONTROL
GROUP
Table 12: Mean Standard Deviation and mean difference in experimental and control group.
Group Experimental Group Control Group

thth h
Before During 1st 5th 10th Before During 1st 5th minute 10th
minute minute Minute minute minute
Mean 0.66 5.30 4.15 1.91 0.30 0.93 8.65 6.43 3.63 1.87
SD 1.89 1.74 1.51 1.12 1.78 1.24 2.05 24.1 1.33 1.21
Table 12:Depicts that majority of infants, in experimental group with Helfer Skin Tab Technique before mean is 0.66, SD 1.89, and
during mean is 5.30, SD 1.74 and mean 1st minute is 4.15, SD 1st minute 1.51. And mean 5th minute is 1.91, SD 1.12 and mean
10th minute is 0.30, SD 1.78 .where as in control group before mean is 0.93,SD 1.24, and during mean is 8.65, SD 2.05 and mean
1st minute is 6.43, SD 24.1 and 5th minute mean is 3.63, SD 1.33 and mean 10th minute is 1.87,SD 1.21.
79
EXPERIMENTAL GROUP
6
5.3
P
E 5 4.15
R
C 4
E
N 3 Mean
1.89 1.91 1.78
T 1.74 SD
A 2 1.51
1.12
G 0.66
E 1 0.3
0
Before During 1 st 5th 10th
Figure 14: Mean, Standard Deviation in Experimental group.
80
CONTROL GROUP
30
24.1
25
P
E
R 20
C
E
15 Mean
N
T SD
A 10 8.65
G 6.43
E
5 3.63
0.93 2.05 1.87 1.21
1.24 1.33
0
Before During 1 st minute 5th minute 10th
minute
Figure 15: Mean, Standard Deviation in Control group.
81
SECTION IV: EFFECTIVENESS OF HELFER SKIN TAP
TECHNIQUEAMONG INFANTS DURING INTRA MUSCULAR
VACCINATION IN EXPERIMENTAL GROUP AND CONTROL GROUP
H1: There will be a significant difference in reduction of pain during

intramuscular vaccination among infants receiving Helfer Skin Tap Technique
in experimental group.
Table 13: Comparison of pain level during intramuscular

vaccination among infants in experimental group by using unpaired
‘t’test
n=30
S. No Experimental Mean± SD Calculated Table Value

group ‘t’value
1 Before 0.66±1.89
(5minutes) 10.20 2.05
2 During 5.30±1.74 8.77
3 1stminute 4.15±1.51 7.75 2.05
4 5th minute 1.91±1.12 5.20 2.05

5 10thminute 0.30±1.78 2.52 2.05
Table13: Describes that infants in experimental group mean is 0.66 and SD

1.89 before 5 minutes and the calculated “t” value is 10.20. Mean 5.30 and
SD 1.74 during and the calculated “t” value is 8.77. Mean 4.15 and SD 1.51,
1st minute and the calculated “t” value is 7.75. Mean 1.91 and SD 1.12, 5 th
minute and the calculated “t” value is 5.20. Mean 0.30 and SD 1.78, 10 th
minute and the calculated “t” value is 2.52.as the calculated t value are
greater than the table value hence Helfer Skin Tap Technique was effective in
82
reducing pain during intramuscular vaccination among infants. Hence sated
Hypothesis H1 is accepted
Table14: Comparison level of pain among infants During intra

muscular vaccination pain in control group by using paired ‘t’ test
n=30
S.No Control group Mean ±SD Calculated ‘t’ Table value

value
1 Before(5minutes) 0.93±1.24 1.57 2.05
2 During 8.65±2.05 1.98
2.05
3 1st minute 6.43±24.1 0.28 2.05
4 5th minute 3.63 ± 1.33 2.04 2.05
5 10th minute 1.87±1.21 1.90 2.05
Table 14: Describes that infants in control group mean Mean is 0.93 and SD
1.24 before 5th minutes and the calculated “t” value is 1.57. Mean 8.65 and
SD 1.74 during and the calculated “t” value is 1.98. Mean 6.43 and SD 24.1,
1st minute and the calculated “t” value is 0.28. Mean 3.36 and SD 1.33, 5 th
minute and the calculated “t” value is 2.04. Mean 1.87 and SD 1.21, 10 th
minute and the calculated “t” value is 1.90.
83
Table 15: Comparison of pain of intramuscular vaccination pain between
experimental and control group of infants during intramuscular
vaccination by using un paired ‘ t’ test.
(n = 30 + 30)
Experimental group Control group Calculated Table

't' value value
Mean ±SD Mean± SD
5.30 ± 1.74 8.65 ± 2.05 7.45 3.46
During
1st minute 4.15 ±1.51 6.43 ± 24.1 3.48 3.46
5th minute 1.91 ±1.12 3.63 ± 1.33 7.81 3.46

10thminute 0.30±1.78 1.87 ± 1.21 4.36 3.46
Over all Mean 3.13 ± 1.41 5.14± 7.92 7.51 3.46
And SD
Table 15: Indicate that there was a significant difference in the pain level of infants
in the experimental group and control group (over all M± SD=3.13± 1.41)5.14 ±
7.92,t=3.46). During the intramuscular vaccination in experimental group infants
experienced moderate pain (5.30 ± 1.74)where as in control group experienced
(8.65 ±2.05) severe pain.1stminute the experimental group infants had mild pain
(4.15±1.51) where as in control group infants had moderate pain (6.43±24.1), at
5thminute in experimental group infants experienced mild pain(1.91±1.12) where
as in control group infants experienced moderate pain (3.63± 1.33) at10thminute in
experimental group infants were relaxed and comfortable(0.30 ±1.78) where as in
control group infants experienced mild pain(1.87 ±1.21). It can be concluded that
Helfer Skin Tap Technique was effective in reducing the pain perception in
experimental group compared to control group during and after intra muscular
vaccination.
Hence, the stated Hypothesis H1 is accepted.
84
SECTION V: CHI - SQUARE VALUE WILL BE COMPUTED TO FIND OUT
THE ASSOCIATION BETWEEN LEVEL OF PAIN AMONG INFANTS
DURING INTRA MUSCULAR VACCINATION WITH THEIR SELECTED
DEMOGRAPHIC VARIABLE IN EXPERIMENTAL GROUP AND CONTROL
GROUP.
H2: There will be significant association between level of pain among infants
during intra muscular vaccination scores with their demographic variables.
Table 16: Association of selected demographic variable with pain level

of infants during intra muscular vaccination in experimental group and
control group.
85
S. No CONTROL GROUP EXPERIMENTAL GROUP
LEVEL LEVEL
CHI- TABLE CHI-
DEMOGRAPHIC OF TABLE OF
SQU Df VALU SQUAR Df
VARIABLES SIGNIFIC VALUE SIGNIFIC
ARE E E
ANCE ANCE
Development
1 0 3 7.82 NS 0 3 7.82 NS
stage
2 Gender 0 3 7.82 NS 3.09 3 7.82 NS
Weight of the
3 0 6 12.59 NS 16.68 9 16.92 NS
baby
Educational
4 Status of 2.9 9 16.92 NS 20.35 9 16.92 S
Father
Educational
5 Status of 5.7 9 16.92 NS 48.35 9 16.92 S
Mother
Occupation 10.7
6 9 16.92 NS 12.21 9 16.92 NS
Father 5
Occupation
7 2.72 9 16.92 NS 9.98 9 16.92 NS
Mother
Type of
8 0.72 6 12.59 NS 44.74 9 16.92 S
delivery
Frequency of
9 IM 1.29 6 12.59 NS 13.67 6 12.59 S

vaccination
S – Significant, NS – not significant, x2-chi-square,Df – degree of freedom.
86
Table 16: Depicts that majority of infants, in control and experimental group or
less chi-square value of selected demographic variables are less than the
table value except educational status of father, educational status of mother,
type of delivery, frequency of IM vaccination which is greater than table value.
Hence, we fail to accept the stated Hypothesis H2
87
88
CHAPTER V
SUMMARY, LIMITATIONS, AND RECOMMENDATIONS
SUMMARY OF THE STUDY:
The present chapter is devoted to the summary of the findings, limitations,

recommendations, conclusions, and suggestions that incorporate the
implications of the study.
The primary aim of the study was to assess the effectiveness of the Helfer
Skin Tap Technique on pain reduction among infants during intramuscular
vaccination in selected paediatric hospitals in Hyderabad.
1. To assess the level of pain among infants during Intramuscular

Vaccination in an experimental group at selected pediatric hospitals
2. To assess the level of pain among infants during intramuscular
vaccination in the control group at selected pediatric hospitals.
3. To determine the effectiveness of the Helfer Skin Tap Technique
among infants during Intramuscular vaccination in reducing pain in the
experimental group.
4. To compare the level of pain among infants during Intramuscular
5. To find out the association between levels of pain among infants during
intramuscular vaccination with the Helfer Skin Tap Technique with their
selected demographic variables.
89
HYPOTHESIS:
H1: There will be a significant difference in the reduction of pain during

intramuscular vaccination among infants receiving the Helfer Skin Tap
Technique in the experimental group.
Comparison of pain level during intramuscular vaccination among infants in

the experimental group by using paired ‘t’ test.
Before (5 minutes) infants were relaxed and comfortable (M±SD=0.66±1.89),

during vaccination infants experienced moderate pain(M ± SD=5.30±1.74)
and post-test at 1st-minute infants had mild pain(M ± SD=4.15±1.51), 5th
minutes infants experienced mild pain(M ± SD=1.91±1.12) and at10th minutes
infants were relaxed and comfortable (M ± SD=0.30±1.78). It shows that there
was a significant reduction of pain score during vaccination (t=10.20 at
p<0.05) and during (t=8.77 at p<0.05), at after the vaccination at 1st minute
(t=7.756 at p<0.05), 5th minute (t=5.20 at p<0.05),10th minute(t=2.52 at
p<0.05). Thus the stated research hypothesis is accepted. Hence there was a
significant reduction in pain perception among infants during intramuscular
vaccination with Helfer Skin Tap Technique.
Comparison level of pain among infants During intramuscular vaccination pain

in the control group by using paired ‘t-test control group during infants were
relaxed and comfortable (M± SD=0.93±1.24),during vaccination infants
experienced severe pain(M ± SD=8.65±2.05,) and at 1st minute infants had
moderate pain(M ± SD=6.43±24.1), 5th minutes infants remains in moderate
pain (M ± SD= 3.63± 1.33) and at10th minutes infants experienced mild pain
(M ± SD=1.87±1.21). It shows that there was a not significant difference in the
pain perception during vaccination (t=1.57 at p<0.05),during (t=1.98 at
p<0.05), after the vaccination at 1st minute (t=0.28 at p<0.05), 5th minute
( t=2.04 at p<0.05) and 10th minute (t=1.90 at p<0.05). Comparison of the
pain
90
of intramuscular vaccination pain between an experimental and control group
of infants during intramuscular vaccination by using paired, t’ test.
There was a significant difference in the pain level of infants in the

experimental group and control group (overall M± SD=3.13± 1.41)5.14 ±
7.92,t=3.46). During the intramuscular vaccination in the experimental group,
infants experienced moderate pain (5.30 ± 1.74) whereas the control group
experienced (8.65 ±2.05) severe pain. Post-test level of pain at 1st minute the
experimental group infants had mild pain (4.15±1.51) whereas, in the control
group, infants had moderate pain (6.43±24.1), at the 5th minute in the
experimental group infants experienced mild pain(1.91±1.12) whereas in
control group infants experienced moderate pain (3.63± 1.33) at 10th minute
in experimental group infants were relaxed and comfortable(0.30 ±1.78)
whereas in control group infants experienced mild pain(1.87 ±1.21). It can be
concluded that Helfer Skin Tap Technique was effective in reducing pain
perception in the experimental group compared to the control group during
and after intramuscular vaccination.
Hence, the stated Hypothesis H1 is accepted.
H2: There will be a significant association between the level of pain among
infants during intra-muscular vaccination scores with their demographic
variables
Association of selected demographic variables with the pain level of infants

during intramuscular vaccination in the experimental group and control group.
The majority of infants, chi-square value of selected demographic variables,

are less than the table value at the probability level of 0.05 which shows there
is no significant association in the experimental group, except the educational
status of the father, educational status of the mother, type of delivery,
frequency of IM vaccination which is greater than table value.
Hence, we fail to accept the stated Hypothesis H2
91
The literature review helps the investigator to get an insight into the present
problem to gain an in-depth knowledge of the content, develop the conceptual
framework for the study, and develop the tool for data collection. The research
approach adopted for the present study was quasi-experimental.
The present study was conducted at Niloufer children’s hospital, Lakdikapul.

The population of the present study consisted of preterm infants born less
than 37 weeks of gestational age admitted to selected pediatric hospitals. A
simple random sampling technique was used to select the sample. A total of
sixty (thirty control and thirty experimental) preterm infants were selected for
this study. A standardized tool was used for the data collection. A tool
consisting of two sections: first, consisting of data related to demographic
variables, and second included Ballard maturational assessment scale. The
same tool had been given for validation to experts in the field of Child Health
Nursing. The tool aided the investigator to gather data related to tactile
kinesthetic stimulation on neuromuscular maturity among preterm infants in
selected pediatric hospitals, in Hyderabad.
The reliability of the tool was checked by the split-half method (coefficient of
correlation by Karl Pearson's formula). The results indicated that the tool was
valid and reliable. Pilot Study was conducted between 22.7.2022 to 27.7.2022
on a sample of 6 for seven days, and the results revealed the feasibility and
appropriateness of the tool. The main study was conducted from 7.08.2022 to
17.08.2022. The data collected from sixty children (thirty control and thirty
experimental) were organized, tabulated, and analyzed with the help of
descriptive & inferential statistics and the findings were interpreted.
92
MAJOR FINDINGS OF THE STUDY:
Section 1: To assess the level of pain among infants during Intramuscular

Vaccination in the control group selected in pediatric hospitals.
In the control group majority of Infants, 30(100%) of infants were between 1 -

6 months, 21 (70%) were female,26 (86.6%) were between 3.6-4.5kg weight
of the baby, educational status of father 16(53.3%)were graduates,
educational status of mother 11 (36.3%) had secondary education, occupation
of father 19 (63.3%) were private Employee, 10 (33.3%) were private
Employee, occupation of mother 10(33.3%)were Housewife, type of delivery
14 (46.6%) were Normal vaginal delivery, frequency of IM vaccination
21(70%) were 2nd Dose
Section 2: To assess the level of pain among infants during intra-muscular

vaccination in an experimental group at selected pediatric hospitals
In the Experimental group majority of Infants 30 (100%) infants were between

1month-6months,19(63.3%) were female,16(53.3%) weight of the baby were
between 4.6-5.5kg,education of father 11(36%) were graduates, education of
mother 11(36.7%) were graduates ,occupation of father 16(53.3%) were
private Employee, occupation of mother 11(36.7%) were private Employee,
type of delivery 15(50%) were LSCS, frequency of IM vaccination 18(60%)
were 3rd Dose. In control group majority of infants 23(76.67%) were relaxed
and comfortable,4(13.33%) had mild pain,2(6.67%)had moderate pain
1(3.33%) experienced severe pain. In experimental group majority of infants
27(90%) were relaxed and comfortable,2(6.67%)had moderate pain 1(3.33%)
experienced severe pain.
Section 3:
Mean and standard deviation to find out the significant difference between
the level of pain among infants during intramuscular vaccination in the
93
in experimental group with helfer skin tab technique before mean is 0.66, SD
1.89, and during mean is 5.30, SD 1.74 and mean 1 st minute is 4.15, SD 1st
minute 1.51. and mean 5th minute is 1.91, SD 1.12 and mean 10 th minute is
0.30, SD 1.78 .where as in control group before mean is 0.93,SD 1.24, and
during mean is 8.65, SD 2.05 and mean 1 st minute is 6.43, SD 24.1 and 5 th
minute mean is 3.63, SD 1.33 and mean 10th minute is 1.87,SD 1.21.
Section 4:
Effectiveness of Helfer Skin Tap Technique among infants during

intramuscular vaccination in experimental group and control group.
The “t” test value in the experimental group is 10.32 which is greater than the
table value is 2.05 at 29 DF. During 8.77,which is greater than the table value
1st minute 7.75, which is greater than the table value is 2.05 at 29 DF 5th
minute 5.20 which is greater than the table value is 2.05 at 29 DF. 10th
minute 2.52 which is greater than the table value is 2.05 at 29 DF.
The “t” test value in the control group is 1.57 which is not greater than the
table value is 2.05 at DF. During 1.98 which is not greater than table value is
2.05DF. After the vaccination in the 1st minute 0.28 which is not greater than
the table value of 2.05 at DF, and in the 5th minute 2.04 which is not greater
than the table value is 2.05 at DF. And the 10th minute 1.90 which is not
greater than the table value is 2.05 at DF.
Section 5:
chi-square value will be computed to find out the association between the
level of pain among infants during intramuscular vaccination with their
94
The calculated chi-square of selected demographic variables like the
developmental stage, gender, weight, education of mother, education of
father, occupation of father, occupation of mother, type of delivery, and
Frequency of IM of vaccination. Expert developmental stage gender, the
weight of the baby, education of mother, education of father, occupation of
father, occupation of mother, type of delivery, Frequency of IM of vaccination.
The majority of infants is less than the table value at the probability level of
0.05 which shows there is no significant association. The computed chi-
square value of the Experimental group except for the Educational status of
the mother (48.35) which is greater than the table value of 16.92 at 9 DF, the
Educational status of the father (20.35) which is greater than the table value
of 16.92 at 9 DF. Type of Delivery (44.74) which is greater than table value
16.92 at 9 DF.The frequency of IM vaccination (13.67) which is greater than
the table value is 12.59 at 6 DF.
Hence, we failed to accept the stated hypothesis H2 - There will be a
significant association with Helfer Skin Tap Technique during intra-muscular
vaccination among infants with their selected demographic variables, except
the Educational status of the mother, Educational status of the father, Type of
Delivery, Frequency of IM vaccination.
DISCUSSION:
Dr.BindhuMathe (2019) conducted one group post test design study The
theory of pain was the conceptual framework adopted and the standardized
obtained. The study explores a method namely Helfer Skin Tap Technique for
minimizing the pain experienced during vaccination in infants.[17]
95
G. BHUVANESWARI, (2018) Conducted an experimental study at in Primary
Health Centre at Neamam. The study samples infants who are receiving
vaccinations intra-muscular injection. The total sample size was 60, and each
sample for the control and experimental groups selected a convenient
sampling technique. Each patient was administered repeated intramuscular
injections at Vastus Lateralise. The pain level with the administration of
intramuscular during vaccination injection of traditional technique was
compared with a pain level with Helfer Skin Tapping Technique. The tool
developed and used for the data collection were socio-demographic variables
and assessment, Universal pain scale Neonatal Infant pain scale (NIPS) was
used to assess the level of pain perception. Results: The pain perception of
patients in terms of the pain level of traditional technique was found to be
significantly higher than the pain level of Helfer skin, tapping Technique, and
the experimental group decreased level of pain and show the significance at
the level of P<0.05 in the pooled standard deviation of the t’s test. Conclusion:
The finding of the study helps to determine the effect of Helfer Skin Tap
Techniques
in reducing pain during intramuscular injection. This cane is implemented by
the health personnel while administering the injection. Reduction in pain
during intramuscular injection would enhance the case of immunization. [16]
The present study was taken up to assess the effectiveness of the Helfer Skin
Tap Technique on pain reduction among infants during intra-muscular
vaccination at selected paediatric hospitals, in Hyderabad.
The basic aim of this study was to evaluate to assess the effectiveness of the
Helfer Skin Tap Technique on pain reduction among infants during
intramuscular vaccination in selected pediatric hospitals, in Hyderabad.
The study was conducted by using a True experimental post-test control

group design. The samples were selected OPD Immunization room in Niloufer
Children’s hospital for conducting the study. The sample size was 60 among
which 30 samples in the experimental group and 30 samples in the control
group were selected by using convenient sampling techniques.
96
The structured self-administered questionnaire was used to assess the
demographic variables among infants. The standardized Pain Assessment
Modified Flacc pain Scale was used as the instrument to measure the pain
during Intramuscular vaccination. The demographic variables were analyzed
by using descriptive measures (frequency and percentage). The responses
were analyzed by using descriptive statistics (mean, frequency, percentage,
and SD). The effectiveness Helfer Skin Tap Technique on pain reduction
among infants during intra-muscular vaccination was analyzed by using
inferential statistics (paired ‘t-test, unpaired ‘t-test).
The “t” test value in the experimental group is 10.32 which is greater than the
table value is 2.05 at 29 DF. During 8.77,which is greater than the table value
1st minute 7.75, which is greater than the table value is 2.05 at 29 DF 5th
minute 5.20 which is greater than the table value is 2.05 at 29 DF. 10th
minute 2.52 which is greater than the table value is 2.05 at 29 DF.
The “t” test value in the control group is 1.57 which is not greater than the
table value is 2.05 at DF. During 1.98 which is not greater than table value is
2.05DF. After the vaccination in the 1st minute 0.28 which is not greater than
the table value of 2.05 at DF, and in the 5th minute 2.04 which not is greater
than the table value is 2.05 at DF. And the 10th minute 1.90 which is not
greater than the table value is 2.05 at DF. Association between the pain level
during intramuscular vaccination and the selected demographical variables
were analysed by using the chi-square test.
NURSING IMPLICATIONS:
The findings of the study have several implications. infants in the experimental
group had an improvement in the level of pain during Intramuscular
Vaccination when compared to the infants in the control group. The results of
the study show that Helfer Skin Tap Technique on pain reduction among
Infants during Intramuscular vaccination was effective in infants in pediatric
hospitals. The finding of the present study has several implications that are of
97
vital concern for nursing practice, nursing education, nursing administration,
and nursing research.
Nursing practice:
 Nurse has to be trained in applying Helfer Skin Tap Technique on pain

reduction among infants undergoing intramuscular vaccination in
clinical and community settings.
 Emphasis the nurses to use the FLACC Pain scale in their daily
practice to assess the pain of infants during vaccination.
 Helfer Skin Tap Technique can be adapted to the procedure of intra-
muscular injection.
 Nurses can be taught about the Helfer Skin Tap Technique and it can
be practiced in the clinical setting.
 As there is not much empirical evidence for the procedure of intra-
muscular injection findings can be merged into evidence-based nursing
practice
Nursing education:
 Helfer Skin Tap Technique can be Included in the literature on Intra

Muscular Vaccination
 Nursing Students can be taught about Helfer Skin Tap Technique for
Intra Muscular Injection
 Non-pharmacological measures of the Helfer Skin Tap Technique can
also be included in the nursing curriculum.
 Organizing Continuing education for staff nurses will help to promote
and update their knowledge on the usage of the Helfer Skin Tap
Technique on pain reduction among infants undergoing intramuscular
vaccination
98
Nursing administration:
 Nurse administrators should take more responsibility to incorporate the

importance of holistic care in Infants.
 The nurse administrator should explain the effectiveness of the Helfer
Skin Tap Technique to the staff nurses and motivate them to practice in
the Immunization room.
 The nurse administrators should organize in-service education
programs on Helfer Skin Tap Technique
 Organize in-service education programs for the nurses on this
complementary technique.
 Develop a written protocol on methods of Helfer Skin Tap Technique
implication.
 Nurse administrators could formulate policies and procedures
regarding the Helfer Skin Tap Technique. Provision should be made for
the staff working in the vaccination clinic to get training in regular usage
of non-pharmacological measures.
 Nursing administrators can motivate nurses to use Helfer Skin Tap
Technique in their clinical practice among Infants undergoing
intramuscular vaccination through ongoing training.
 The protocol of administration of the IM vaccine can be reframed with
the Helfer Skin Tap Technique.
Nursing research:
 Nursing researchers should be aware of the new trends and existing

healthcare systems.
 Practice evidence-based nursing to maximize the optimum care for the
clients.
 Add to the research review the importance of the Helfer Skin Tap
Technique on pain reduction among infants during Intra Muscular
vaccination.
 Disseminate the findings through journals and publications.
99
 Nurse researchers can conduct studies to verify the scientific principle
and physiology behind the effect of skin tapping on Intramuscular
vaccination pain reduction.
 Randomized clinical trials could be undertaken so that the validity of
the results can be increased and it can be incorporated into the
evidence-based nursing practice.
LIMITATIONS:
The study has the following Limitations:

The vaccination pain may have varied according to the technique
 vaccination and the skill of the nurse in administering the IM vaccine.
 Generalization cannot be made due to the limited area of setting and
limited sample size.
 The study was limited to assessing the Effectiveness Helfer Skin Tap
Technique on pain reduction among Infants during Intra Muscular
vaccination.
RECOMMENDATIONS:
A similar study can be conducted in a large group of

 population.
 A similar study can be conducted in all age groups of children.
 A study can be conducted to assess the effectiveness of the Helfer
Skin Tap Technique on pain reduction among children undergoing
various types of vaccination.
100
CONCLUSION:
The following conclusions were drawn based on the findings of the study.
The main conclusion drawn from the present study was that most of the
infants who were receiving intramuscular vaccination were Relaxed and
Comfortable, and had Mild Pain, Moderate Pain, and Severe Pain. After
receiving the Helfer Skin Tap Technique, the level of pain during
intramuscular vaccination among infants was reduced significantly. It is
concluded that the Helfer Skin Tap Technique is effective in reducing pain
during intramuscular vaccination among Infants.
101
102
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NETREFERENCE:
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among Infants during Intramuscular vaccination on at Selected
Hospital
2. www.pubmed.com-EffectofHelfer Skin Tap Technique on pain
reduction among Infants during Intramuscular vaccination Infants: A
Randomized Clinical Trial
3. www.academicjournals.org - A study to assess the effect of Helfer
Skin Tap Technique on pain reduction among Infants during
Intramuscular vaccination in selected hospital at Nagercoil
4. www.pretermlowbirthrates.ncbi.com- a study to assess the effect of
Helfer Skin Tap Technique on pain reduction among Infants during
Intramuscular vaccination in selected hospital.
109
i
APPENDIX – A
CONTENT VALIDATION CERTIFICATE
I hereby certify that I have validated the tool of MRS.KUBHAM NIHARIKA, II

year M.Sc. nursing student (Child Health Nursing), who has undertaken the
following study,
“A STUDY TO ASSESS THE EFFECTIVENESS OF HELFER SKIN TAP

TECHNIQUE ON PAIN REDUCTION AMONG INFANTS DURING INTRA
MUSCULAR VACCINATION AT SELECTED PEDIATRIC HOSPITAL,
HYDERABAD”.
Place: Signature of the expert:
Date: Designation:HOD
ii
APPENDIX - B
LETTER REQUESTING OPINION AND SUGGESTION OF EXPERTS TO VALIDATE THE
TOOL
From
MS. KUMBHAM NIHARIKA
Vijay Marie College of Nursing,
Begumpet, Hyderabad, Telangana.
To
Through The proper channel,

Rev. Sr. Anne Ponnattil,
Principal,
Vijay Marie College of Nursing
Begumpet, Hyderabad 500016.
SUB: Request for expert opinion and suggestions to establish content validity of
tool the research tool.
Respected Sir /Madam/Sister,
This is to introduce ,Ms. KUBHAM NIHARIKA. of M.sc [Child Health Nursing]
Nursing 2nd year student of Vijay Marie college of nursing, Begumpet, Hyderabad,
Telangana, have registered the following topic from my dissertation at the KNR
university to be submitted as a partial fulfillment for the requirement forward of
masters of Science in nursing.
TOPIC: “A Study to assess the effectiveness of Helfer Skin Tap Technique on pain
reduction among infants during intra muscular vaccination at selected pediatric
hospital, Hyderabad”. Here with I have enclosed
 Objectives o f the study.
 Demographic variables.
 Tool.
 Scoring key and scoring procedure.
I request you to go through the items and give your valuable suggestions and
opinions to develop the content validity of the tool. kindly suggest modifications,
additions, if any in the remark column.
Thanking you,
Date: Yours sincerely,
Place KUBHAM NIHARIKA
iii
iv
APPENDIX–C
LETTER SEEKING EXPERTS FOR CONTENT VALIDITY OF TOOL
From,
Mrs. KUMBHAM NIHARIKA,
Begumpet, Hyderabad, Telangana
To,
Forwarded through
The Principal,
Begumpet ,Hyderabad, Telangana.
SUB:Request for consenting to validity of tool.
I am KUMBHAM NIHARIKA 2nd year MSc (Child Health Nursing) nursing

student of Vijay Marie College of Nursing, Begumpet, Hyderabad, Telangana.
The topic selected for my dissertation is “AStudy to assess the effectiveness
Helfer Skin Tap Technique on pain reduction among infants during Intra
Muscular Vaccination at selected pediatric hospital, Hyderabad”.
This is to be submitted to KNR Universit y of Health Science s as a partial fulfillment

of my university requirement of Masters of Science in nursing degree in the second
year. So, I kindly request you to go through the items and give your valuable
suggestions and opinions on the tool.
Thanking you,
Yours sincerely
K. Niharika
v
vi
APPENDIX-D
CERTIFICATE OF TRAINING
vii
APPENDIX-E
LETEER REQUESTING PERMISSION TO CONDUCT PILOT
STUDY
viii
APPENDIX-F
LETTER REQUESTING PERMISSION TO CONDUCT MAIN
STUDY
ix
APPENDIX– G
CRITERIA CHECK LIST FOR VALIDATION OF TOOL
NOTE: Please review the items in the tool and give your suggestions
regarding accuracy, relevance and appropriateness of the content. If there are
any suggestion so comments, please mention in there mark column.
SECTION–A
DEMOGRAPHICVARIABLES
6
7
x
SECTIONB-MODIFIED FLACC PAIN SCALE

FINDING (5MINUTES)
1stminut 5thmi 10thmi
e nute nute
FACE

0-Relaxed
(Tight facial muscles, Furrowed brow,
1-Grimace chin, jaw)
LEGS

ACTIVITY

1-squirming, shifting back (Head movement, back, and forth,

and forth, tense aggression)
2-Arched, rigid, or jerking Head banging, shivering , breath-holding,

gasping or sharp intake of breaths,
severe splinting.
CRY
CONSOLABILITY
O-Content ,relaxed
1- Reassured by touching
,hugging or being talked to
distractible
2- Difficiult to console or Pushing away caregiver, resisting care or

comfort comfort measures
xi
INTERPRETATION:
0-Relaxedandcomfortable
1-3-Mild pain
4-6-moderate pain
7-10-severepain
xii
APPENDIX- H
LIST OF EXPERTS IN THE FELID OF MEDICINE
1) DR.K. Rama, MD
Senior Consultant Pediatrician
Vijay marie Hospital& Education Society
Khairatabad, Hyderabad,TS
2) Dr.M.Surendranath
Senior Consultant Pediatrician
3) Dr. S. Vihari
DNB Neonatalogist
4) Dr.AnserM.Hussain
Consultant Pediatrician and Neonatologist
xiii
4). G.Haridas
Nursing Director
Rainbow Children’s Hospital
Jublihills Hyderabad.
LIST OF EXPERTS IN THE FELID OF NURSING
5). Ms. V. Stephina Immaculate
Assistant professor
Gokulam College of Nursing
6).Ms. Shanthi
Assistant Professor
Child Health Nursing
Esshwari Bai College of Nursing
West Maredpally, Secunderabad
7.) Ms. Hashitha Mam
Associate Professor
Child Health Nursing Department
Yashoda College of Nursing
Saroornagar, Hyderabad, TS.
xiv
APPENDIX – I
INFORMED CONSENT FORM
Dear Subject,
I, Mrs. KUMBHAM NIHARIKA, M. Sc (N) II year student, at Vijay Marie

College of Nursing, have registered the following study KNR University of
Health Sciences, Warangal, as a partial fulfilment of my Master’s Degree and
require your co-operation for the successful completion of my study.
TITLE OF THE STUDY:
“A study to assess the effectiveness of helfer skin taps technique on pain

reduction among infants during intramuscular vaccination at paediatrics
hospitals, Hyderabad”.
PLEASE READ THE PARTICULAR BELOW BEFORE SIGNING

THE CONSENT TO ALLOW YOUR INFANT TO BE STUDY
SUBJECT.
PURPOSE OF THE STUDY:
Helfer Skin Tap Technique provides a mechanical stimulation and distraction

during intramuscular injection and thus helps to decrease pain as described
by gate control theory which keeps the muscles relaxed thus reduce pain
while administering IM injection
xv
PROCEDURE:
When you agree to participate in my research, you will be asked to answer a

few questions regarding your infant baby, Developmental stage Gender of the
baby Weight of the baby, Educational status of father, Educational status of
mother Occupation of the father, Occupation of the mother, Type of delivery,
Frequency of IM vaccination .
BENEFIT:
Health care Professional trying to provide vaccine to the infants with a less
painful experience at their level of comport.Skin tapping (Helfer Skin Tap
Technique ) is one of the methods which keeps the muscles relaxed and thus
reduce pain while administering IM vaccination .
RISK:
There is no risk associated with this procedure.
CONFIDENTIALITY:
Your study will be handled in the most confidential manner. If results of the
study are published or presented ,individual names and other personally
identifiable information will not be used. To minimize the risks of confidentiality,
I will code and limit access to study recorded.
xvi
RIGHTS:
PARTICIPATION IN RESEARCH IS COMPLETELY VOLUNTARY. You are

free to take part in the project, and stop at any time. Whether or not you
choose to participate in the research and answer there will be no penalty to
you or loss to which you are otherwise entitled.
YOURINFANTSHASBEENSELECTEDFORTHEFOLLOWINGRE
ASONS:
Your Infant is:
 Infant Age 1month -12months old.
 Available at the time of data collection.
 Been permitted by you for participation in the study.
 Infants receiving during intra muscular vaccination at vastus lateralis.
AS APART OF THE STUDY,YOU ARE EXPECTED TO:
 Respond based on your knowledge.
 Participate depending on the needed duration.
 Inform if you feel any discomfort while participation.
 For any explanations or queries you can contact the investigator

on+917659005094
xvii
CONSENT:
I understood all the details mentioned above and I am will to allow

my preterm infant to participate in the study.
Name of the parent: Name of the Investigator:
Signature of the Parent: Signature of the Investigator:
Date: Date:
xviii
APPENDIX-J
CERTIFICATE OF EDITING IN ENGLISH
This is to certify that the present study undertaken by MS. NIHARIKA

KUMBHAM, MSc Nursing II year student of Vijay Marie College of Nursing,
Begumpet, for her study topic “is “A study to assess the effectiveness of
Helfer Skin Tap Technique on pain reduction among infants during
intramuscular vaccination at paediatrics hospitals, Hyderabad”is submitted for
its accuracy in English.
This study has been edited in English by,
B Monalisa
MA English,
University of Hyderabad.Date: 28/7/2021
Signature
xix
APPENDIX– K
IN THIS STUDY THE INVESTIGATOR PREPARED A TOOL WITH TWO

SECTIONS.
 Section A consists of demographic variables,
 Section B consisted of Modified FLACC Pain Scale, which

recorded level of pain during Intramuscular vaccination
before and after intervention among infants. The toll is
constructed based on review of the literature of the present study
and with the guideline from the guide and experts. The tool is
developed considering the content validity, reliability and
feasibility.
Instructions:
1. Read through the following questions
2. Answer all the given question
3. Tick the correct option
xx
SECTION – A
DEMOGRAPHIC
VARIABLES:
1. Developmental Stage [ ]
a) 1month-6months
b) 7 months -1 year
2. Gender [ ]
a) Male
b) Female
3. Weight of the baby [ ]
a) 3.6-4.5kg
b) 4.6-5.5kg
c) 5.6-6.5kg
d) >6.5kg
4. Educational status of father [ ]
a) Illiterate
b) Primary
c) Secondary
d) Graduate
xxi
5. Educational status of mother [ ]
a) Illiterate
b) Primary
c) Secondary
d) Graduate
6. Occupation of father [ ]
a) Government employee
b) Private employee
c) Business
d) Labour
7. Occupation of mother [ ]
a) Government employee
b) Private employee
c) Business
d) House wife
8. Type of delivery [ ]
a) Normal vaginal delivery
b) LSCS
C) Vacuum
d) Forceps
xxii
9. Frequency of IM vaccination [ ]
a) 1st Dose
b) 2nd Dose
c) 3rd Dose
Section B:
FLACC pain scale. The FLACC Scale was Developed by Sandra Merkel,
Voepol-Lewis T.et al., (1997). It consists of characteristics like Face, leg,
Activity, Cry, consol ability which is measured to assess pain level for infants
between the ages of 6-14 wks. Each criterion was assigned a score of 0,1 or
2. The FLACC pain scale had marking from 0 to 10, where 0 indicate relaxed
and comfortable and 10 indicate severe pain. The interpretation of FLACC
pain rating scale had the score of 0 (relaxed and comfortable), 1-3 (mild pain),
4-6 (moderate pain), 7-10 (severe pain). FLACC scale had an established
inter rater reliability value of 0.88.
xxiii
SECTIONB-MODIFIED FLACC PAIN SCALE:

FINDING (5MINUTES
1stmin 5thmin 10thmi
) ute ute nute
FACE

0-Relaxed
(Tight facial muscles, Furrowed brow, chin,
1-Grimace jaw)
LEGS
ACTIVITY

1-squirming, shifting (Head movement, back, and forth, aggression)

back and forth, tense
Head banging, shivering , breath-holding,
2-Arched, rigid, or gasping or sharp intake of breaths, severe
jerking splinting.
CRY
CONSOLABILITY
O-Content ,relaxed
1- Reassured by
touching ,hugging or
being talked to
distractible
Pushing away caregiver, resisting care or
2- Difficiult to console or comfort measures
comfort
xxiv
INTERPRETATION:
0-Relaxedandcomfortable
1-3-Mild pain
4-6-moderate pain
7-10-severepain
Research Design Notation:
GROUP INTERVENTION POST-TEST
X O1
Experimental Group
- O2
Control Group
KEY:
E-Experimental group
X- Helfer Skin Tap Technique
C- Control group
O1- Post test
O2- Post test
xxv
APPENDIX– L
PROCEDURE ON HELFER SKIN TAP TECHNIQUE
DEFINITION
Helfer skin tap technique: Tapping over the intramuscular injection site
with the palmer aspect of finger 16 times before and the 3 counts during the
intramuscular vaccination and continue the tapping till needle was removed.
INDICATION
 To decrease pain levels during IM vaccination
 To reduced incidence for complications
 To improve activity of the muscle relaxation to reduce the pain level

during IM vaccination.
General Instructions:
 While Skin tapping very gentle way
 Avoid over pressure
 Handle infant gently and carefully
Contraindications
 Infants with medical conditions
 Infant who are on ventilator
xxvi
PROCEDURE OF HELFER SKIN TAP TECHINUQUE
 Preparation of procedure
 Informed consent taken by mother after explaining the procedure.
 Mother was all owed to observe the technique of Helfer Skin Tap
Technique.
 Prepare the infant for procedure and provide comfortable position.
 Hand washing should be done before touching infant.
 Hand washing should be done and after touching infants
 After procedure provide calm and quiet environment for infants.
 Hand wash should be done after procedure.
 Infants were identified as per inclusion criteria
 Infants were placed in supine position
 Demographic variables were assessed for both Experimental and
control group.
 After identified the intramuscular injection site, the injection site was
tapped 16 times approximately 10 seconds before intramuscular
injection with the palmer aspect of the dominant hand to relax the
muscle.
 During the injection, the researcher tapped near the injection site 3
times when the injection given.
 Continue tapping near the injection site till the needle was removed.
 After the injection the level of pain is assessed by using FLACC scale
at 1st minute,5th minute, 10th minute.
xxvii
Investigator Observation of Infants Before Helfer Skin Tap Technique.
Investigator Administering Helfer SkinTap Technique on Infants
xxviii
Administration of Helfer Skin Tap Technique During Intra muscular
vaccination on infants by an Investigator
Investigator assessing the level of pain at 1st Minute Of Helfer Skin

Tap Technique on Infants.
xxix
Investigator assessing the level of pain at 5th Minute of Helfer Skin Tap
Technique
xxx
Investigator assessing the level of pain After 10th Minute Of Helfer Skin
Tap Technique on Infant
xxxi
APPENDIX - M
MASTER DATA SHEET OF DEMOGRAPHIC VARIABLES IN EXPERIMENTAL GROUP
Gender Weight Education Education Frequency of
SI Developmental Occupation Occupation Type of
of the of the status of status of IM
NO stage of Father of Mother delivery
baby baby Father Mother Vaccination
1 A B A B A A A A B
2 A B B C A B B B B
3 A A B B D A C A B
4 A A A C B B B C B
5 A B C A B A C A B
6 A B B B A B B B B
7 A A A C C A B A B
8 A A C B A C C C B
9 A B C A C B B A B
10 A A A C D C C B B
11 A B B C C B B A C
12 A B C B D C C C C
13 A A C A B B B A C
14 A A B B D C C B C
15 A B B B D B B A C
16 A A C A B C B B C
17 A B B B C B C A C
18 A B B D D B B B C
19 A B C B B C B A C
20 A A B B D B C B C
21 A A C D D B C B C
22 A B B D B C D B C
23 A B C D D B D B C
24 A B B D B B D B C
25 A B C D D C D B C
27 A B B D D B D B C
29 A B B D C D D D A
30 A A B D B D D D A
xxxii
MASTER DATA SHEET OF DEMOGRAPHIC VARIABLES IN CONTROL GROUP
Developm Gender Education Education Occupati Occupatio

Weight of Type of Frequency of IM
SI NO ental of the status of status of on of n of
the baby delivery Vaccination
stage baby Father Mother Father mother
1 A B A A A B B A A
2 A B A A A B A A B
3 A B A B A B B A B
4 A B A B B B A B B
5 A B A C B B C B A
6 A B A C B B C B B
7 A A A C B A B A C
8 A B A C B A B A B
9 A B A C B B C A C
10 A B A C B B C B B
11 A A A C B B D B B
12 A B A C B B D B C
13 A A A C B B C C B
14 A B A C D B D B B
15 A B A D D D D A B
16 A B A D D D C C B
17 A B A D D C D B B
18 A A A D D C C A B
19 A B A D D C D A B
20 A A A D D C D C B
21 A B A D D C C C A
22 A A A D D C D B B
23 A B A D D C B A B
24 A A A D D B B B B
25 A B A D C B B A B
26 A B A D C B B B B
27 A B B D C B B A B
28 A A B D C B B B C
29 A B C D C B D A C
30 A A C D C B D B C
xxxiii
MASTER DATA SHEET ON LEVEL OF PAIN IN EXPERIMENTAL GROUP
Before 5 After
S.NO During
Minutes 1st minute 5th Minute 10th minute
10 10 10 10 10
1 0 3 0 0 3
2 0 3 3 3 3
3 0 3 3 3 0
4 0 8 3 3 0
5 0 8 3 3 0
6 7 8 3 0 0
7 8 8 3 0 0
8 0 7 3 3 0
9 0 7 3 0 0
10 0 7 3 0 0
11 0 7 3 3 3
12 0 7 7 3 3
13 0 0 7 3 0
14 0 7 7 0 0
15 0 7 7 0 0
16 0 7 7 0 0
17 0 7 7 3 7
18 0 7 7 3 7
19 0 7 7 3 7
20 0 7 7 0 7
21 0 7 7 3 7
22 0 7 7 0 0
23 0 3 7 7 0
24 0 7 7 7 0
25 0 7 7 7 0
26 0 7 7 7 0
27 0 3 7 7 0
28 0 7 7 3 0
29 7 3 7 3 0
30 0 7 7 3 0
xxxiv
MASTER DATA SHEET ON LEVEL OF PAIN IN CONTROL GROUP
Before 5 After
During
S.No Minutes st th
1 Minute 5 Minute 10th Minute
10 10 10 10 10
1 0 8 7 3 0
2 0 8 8 7 0
3 0 8 7 3 3
4 0 8 8 7 3
5 0 8 7 3 0
6 7 8 8 6 3
7 8 8 7 3 3
8 0 8 7 7 0
9 0 8 7 3 2
10 0 8 7 6 2
11 0 8 7 3 3
12 0 8 8 7 2
13 0 8 7 3 0
14 0 8 8 6 0
15 0 8 8 3 2
16 0 8 7 7 3
17 0 4 8 3 3
18 0 8 7 3 2
19 0 8 8 3 3
20 0 4 7 3 2
21 0 8 8 3 3
22 0 8 7 3 2
23 0 4 8 3 3
24 0 8 7 3 2
25 0 8 8 6 3
26 0 8 7 7 3
27 0 8 7 7 2
28 0 8 7 6 3
29 7 8 7 7 3
30 0 8 8 6 2
xxxv

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“A STUDY TO ASSESSTHE EFFECTIVENESS OF HELFER

SKIN TAP TECHNIQUE ON PAIN REDUCTION AMONG

VIJAY MARIE COLLEGE OF NURSINGBEGUMPET,

HYDERABAD 16, TELANGANA

KNR UNIVERSITY OF HEALTH SCIENCES

DATE: Signature of the Candidate

A True experimental study to evaluate the effectiveness of “A study to assess

The objectives of the study were:

 To assess the level of pain among infants during Intra muscular

MAJOR FINDINGS OF THE STUDY:

In control group majority of Infants developmental stage 30(100%) of infants

In Experimental group majority of Infants developmental stage 30 (100%)

In control group majority of infants 23(76.67%) were relaxed and comfortable,

Where as In experimental group majority of infants 27(90%) were relaxed and

The study leads to the following conclusions:

1. The similar study can be conducted in large group of population.

CHAPTER CONTENT PAGE

 Studies related to pain experience by 24-28

infants during immunization

 Studies related to Helfer Skin Tap

infants during intra muscular

 Studies related to effectiveness of 32-36

various interventions on reduction of

pain among Infants during intra muscular

IV DATA ANALYSIS AND INTERPRETATION 52-55

Frequency and percentage distribution of

infants according to their demographic

experimental group and control group.

Mean and standard deviation to find out

significant difference between level of pain

among infants during intra muscular vaccination 78-80

in experimental group and control group.

Effectiveness of Helfer Skin Tap Technique

among infants during intra muscular vaccination 81-83

in experimental group and control group.

chi - square value will be computed to find out

the association between level of pain among 84-86

infants during intra muscular vaccination with

their selected demographic variable in

experimental group and control group.

V SUMMARY,LIMITATION AND 87-88

Comparison of pain of intramuscular

1 Conceptual frame work based on Gate Control theory 20

2 Schematic Representation of research methodology 41

Percentage distribution of infants according to their

14 Mean, Standard Deviation in experimental group 79

15 Mean, Standard Deviation in Control group 80

“Let us come before him with thanksgiving.”

My thanks to the nursing superintendents of Vijay Marie Hospital, Khairtabad,

This acknowledgment is incomplete without thanking all the staff nurses

A particular thanks to my family members, especially my husband, who

“A BABY IS BORN WITH A NEED FOR LOVE AND NEVER OUTGROWS

“FRANK AND CLARK”

Child survival is a field of public health concerned with reducing child

The Centres for Disease Control and Prevention recommends vaccinations to

An intramuscular injection is common, yet a complex technique used to

A pain-producing stimulus sends an impulse across a peripheral nerve fiber.

Vaccinations in Infants and Children: