The Final Draft Protocol - MSSM GROUP 2 (17 Feb)
The Final Draft Protocol - MSSM GROUP 2 (17 Feb)
The Final Draft Protocol - MSSM GROUP 2 (17 Feb)
Table of Contents
TITLE............................................................................................................1
RESEARCHERS.............................................................................................1
INTRODUCTION............................................................................................2
RESEARCH QUESTION & OBJECTIVES..........................................................6
METHODOLOGY...........................................................................................7
1. Study design:______________________________________________________________
2. Sample/study participants:_________________________________________________
3. Measurement:______________________________________________________________
4. Methodological and measurement errors:___________________________________
5. Pilot study:_________________________________________________________________
6. Analysis:___________________________________________________________________
IMPLEMENTATION OF FINDINGS.................................................................10
TIME SCHEDULE........................................................................................11
BUDGET.....................................................................................................12
ETHICAL ASPECTS......................................................................................13
REFERENCES.............................................................................................14
ADDENDUMS.............................................................................................17
7. Curriculum Vitaes:________________________________________________________
8. Supervisor HPCSA registration:____________________________________________
9. TRREE Certificates:_______________________________________________________
10.________________________________________________________________Cover Letter:
___________________________________________________________________________
11.______________________________________Information document for participants:
___________________________________________________________________________
12.______________________________________________________________Questionnaire:
___________________________________________________________________________
13.______________________________________________________Redcap Questionnaire:
___________________________________________________________________________
14.__________________________________________________________Permission Letters:
___________________________________________________________________________
3
15.___________________________________________________________Application Letter
___________________________________________________________________________
4
TITLE
Average daily amounts of caffeine consumed by doctors in the
Bloemfontein Hospital Complex
RESEARCHERS
Supervisor:
Department Anaesthesia
Contact Information:
E-mail: nadia.vonwielligh@gmail.com
STUDENTS
See attached addendums for the CVs and Ethical certificates of all collaborators
5
INTRODUCTION
Caffeine, a stimulant of the central nervous system1,4,8, is one of the most commonly
consumed psychoactive substances worldwide5. It is a plant alkaloid with a chemical
structure of C8H10N4O21. The impact of caffeine on human health has a variety of
potential benefits as well as adverse effects associated with excessive caffeine
intake. Daily intake of caffeine (1,3,7 - trimethylxanthine) is prevalent in
contemporary society2. In many regions globally individuals predominantly partake in
caffeine intake regardless of their age or socioeconomic state 2. Caffeine is found in
a wide range of products such as coffee, tea, energy drinks, energy shots, and other
drinks for example kombucha and hot chocolate 3. Each of these products is
distinguished by having compounds from the xanthine group (caffeine, theophylline,
and theobromine), with caffeine being the most potent among them2.
However, excessive caffeine intake can lead to a variety of negative health effects,
including anxiety, insomnia, irritability, nervousness, gastrointestinal disturbances,
9,10
and cardiovascular complications such as tachycardia and palpitations .
Moreover, the risk of addiction and dependence with accompanying withdrawal
symptoms also remains a significant concern with high levels of caffeine
consumption6.
The Ministry of Food and Drug safety suggested amounts of caffeine to minimize the
risk of toxicity are not to consume an average of more than 400 mg of caffeine daily,
which amounts to about five energy drink cans or four cups of Americano coffee 14,15.
Caffeine consumption also risks becoming harmful if levels higher than 200 mg of
caffeine is consumed at once: in other words, about 2,5 cups of coffee in one sitting
14,15
. Pregnant women are advised to not consume more than 300 mg caffeine
daily14,15. On the other hand, an intake of less than 2.5 mg of caffeine per kilogram of
body weight is suggested for children14,15.
Caffeine consumption primarily alleviates fatigue and drowsiness but has numerous
additional therapeutic applications. The US Food and Drug Administration (FDA) has
approved caffeine for treating apnea of prematurity. Off-label uses of caffeine include
the treatment of migraines and post-dural puncture headaches, as well as enhancing
athletic performance, particularly in endurance sports11.
7
The top five reasons for caffeine use are alertness, habit, mood, social, taste, and
symptom management. According to the results of the exploratory factor analysis
(EFA) and the confirmatory factor analysis (CFA), the previously established
categories were modified.
Habit, symptom management, mood, and social were retained. The habit factor
includes items that characterise caffeine consumption as a ritual or a daily routine.
Items of the symptom management factor refers to the reduction of headaches and
caffeine’s positive effect on blood pressure. The mood factor includes items about
optimizing mood with caffeine, and the social factor includes items that imply the
importance of caffeinated drinks in social settings. The consumption factor, because
of the taste or the smell of the beverage, was renamed to taste because only the
items related to caffeinated beverages' flavour were retained. Other items related to
smell and temperature were removed. Ceasing fatigue, invigoration and improving
concentration appeared to belong to one factor that was named alertness11.
While women reported significantly more caffeine use than men, men reported more
energy drink use16. Energy drinks, regardless of frequency of use, were associated
with all adverse health behaviours, but only in female students 16. Similarly, daily
caffeine use from any source was significantly associated with alcohol, non-
prescription drug, and tobacco use in female students, but in men, the association
was less robust16.
Males showed greater positive subjective effects than females. In females, higher
levels of estradiol were associated with little or no subjective responses to caffeine,
but lower levels of estradiol were associated with negative subjective responses to
caffeine relative to placebo17. There were gender differences in cardiovascular
responses to caffeine, with males showing greater decreases in heart rate after
caffeine administration than females, but females showing greater increases in
diastolic blood pressure than males after caffeine administration 17. These gender
differences may be related to steroid hormone concentrations. Blood pressure
responses to caffeine were lower in males when estradiol was high, but higher in
females when estradiol was high17.
A prior study conducted in 2023 in Korea indicates that medical students exhibit a
strong reliance on caffeine, accompanied by various symptoms related to this
dependency13. Consequently, due to the diverse side effects of caffeine and its
numerous users, we have developed a study to assess the average caffeine
consumption across various departments in the Bloemfontein hospital complex. This
research aims to explore both the positive and negative effects of caffeine usage,
analyzing existing literature and empirical data to provide a comprehensive overview
of its impact on the physical and mental health of doctors in the Bloemfontein
hospital complex.
By critically examining the benefits and drawbacks of caffeine, this study seeks to
contribute to a better understanding of how to balance its consumption for optimal
health outcomes and the performance of medical doctors.
9
Research Question:
What are the average daily amounts of caffeine consumed by doctors in all clinical
departments in the Bloemfontein hospital complex?
Primary Objective:
The primary objective of this study is to determine the average daily caffeine
consumption of doctors in all clinical departments of the Bloemfontein hospital
complex.
Secondary Objectives:
The secondary objectives include the most common sources of caffeine being
consumed, the reason for caffeine consumption, the prevalence of effects of
caffeine, and awareness of caffeine consumption in doctors.
10
METHODOLOGY
Study design:
Prospective, descriptive cross-sectional study.
Sample/study participants:
All medical doctors in the clinical departments which includes interns, medical
officers, registrars, and consultants that are employed at Pelonomi Tertiary Hospital,
National District Hospital and Universitas Academic Hospital that consume caffeine
in any form. The exclusion criteria will consist of medical doctors from the clinical
department that are absent the day the questionnaire is administered and who do
not consent to participate in the study.
Measurement:
A questionnaire will be administered to all the medical doctors in the clinical
departments during one of their scheduled weekly academic meetings using an
electronical link. The questionnaire will be voluntary, and the results will remain
anonymous. The questionnaire will be completed during the time of the meeting, not
interfering with any clinical service delivery and all the results will be collected by
members of the research team. The questionnaire is designed specifically for this
study by the researchers, and it is reviewed by the supervisor. It will be administered
only in English as it is the universal language and the participants are professional
medical practitioners fluent in English. Algorithms from medical articles such as
‘Stimulant use among prehospital emergency care personnel in Gauteng Province,
South Africa’ was used as a guide to formulate appropriate questions relevant to the
study19.
The questionnaire evaluates different aspects of the participants that is relevant to
the study: 1. demographic information, 2. caffeine consumption patterns, 3. reasons
for caffeine consumption, 4. awareness and effects of caffeine, 5. caffeine and work
performance, and 6. caffeine reduction or cessation.
11
Pilot study:
A pilot study will be conducted. The questionnaire will be administered to the medical
interns of the anaesthesiology department. This will then be used to identify any
problems with completing the questionnaire as well as the time it takes to complete
the questionnaire. If any changes are made to the questionnaire, an amendment will
be sent to the Health Sciences Research Ethics Committee (HSREC) for approval
before the study is conducted and the data of the pilot study will not be included in
the data set analyzed. If no changes are made, the data will be included in the study.
12
Analysis:
Analysis and interpretation of the data collected on the questionnaires will be done
by the Department of Biostatistics, University of the Free State. Results will be
summarized by frequencies and percentages (categorical variables) and means and
standard deviations, or percentiles (numeric variables).
13
IMPLEMENTATION OF FINDINGS
The findings of this study will raise awareness of dangers of caffeine
overconsumption in doctors as well as the sources thereof, including what the
participants may not have been aware of. By performing the questionnaire, doctors
might become more aware and mindful of the daily amounts of caffeine they
consume and be more attentive when consuming caffeine.
It will also help lay the groundwork for future research in this area, given the limited
existing literature on caffeine consumption in doctors, and the effects thereof,
Furthermore, no similar study, which we could find, has previously been done in
South Africa.
14
TIME SCHEDULE
TIME SCHEDULE
Writing the research report and making June/July 2025 All group members
the presentation
BUDGET
*The kilometres travelled are based on the distances from the UFS Faculty of Health
Science (Francois Retief Building) to Pelonomi Tertiary Hospital and National District
Hospital respectively, according to Google Maps. Universitas Hospital is excluded in
the calculations since it is on UFS grounds.
**The expected price is based on a standard fuel fee of 484c or R 4.84 per kilometre
as per the South African Revenue Service20 to calculate the expected total fuel cost
of the trip.
The expenses will be covered by the MSSM module, as part of the MBChB course at
the University of the Free State department of Basic Health Sciences.
ETHICAL ASPECTS
The protocol will be submitted to the Health Sciences Research Ethics Committee
(HSREC) of the Faculty of Health Sciences at the University of the Free State for
ethics approval and permission will be obtained from the Head of Department of
Anaesthesiology, UFS Gatekeepers, and the Free State Department of Health.
Before asking participants to complete the questionnaire online, the researchers will
give a short description to the group during a scheduled weekly departmental
academic meeting on the topic of the research, the questionnaire and for what the
data will be used for and that the questionnaire is voluntary and anonymous.
The information document, which will be available in English, will provide the
information regarding the research project and researchers. It will highlight that
participation is voluntary, that non-participation will not be held against the person in
any way, that participants may withdraw at any time and that their self-completion of
the questionnaire implies informed consent.
After reading the information document and confirming that the participant
understands all information mentioned in the document, the participant will be taken
to the next page on RedCap where they then start to complete the questionnaire.
Once the completed questionnaire is submitted the data will be included. Data will be
handled confidentially with no names, addresses or contact details noted on the
questionnaires.
Completing the questionnaire as part of this study will not affect daily work or patient
care since the questionnaires will be administered during scheduled academic
meetings in the different clinical departments.
17
REFERENCES
1. Institute of Medicine (US) Committee on Military Nutrition Research. Caffeine
for the Sustainment of Mental Task Performance: Formulations for Military
Operations. Washington (DC): National Academies Press (US); 2001. 2,
Pharmacology of Caffeine. Available from:
https://www.ncbi.nlm.nih.gov/books/NBK223808
2. Smith A. Caffeine: Practical Implications for Understanding its Use and
Effects. Springer Science & Business Media; 2002. Available from:
https://books.google.com/books/about/Caffeine.html?id=HHGxK357LoIC
3. Zhu Z. Caffeinated Drinks Ranked by Caffeine Levels. EatingWell. 2023.
Available from: https://www.eatingwell.com/caffeinated-drinks-ranked-by-
caffeine-levels-8607309
4. Temple JL, Bernard C, Lipshultz SE, Czachor JD, Westphal JA, Mestre MA.
The Safety of Ingested Caffeine: A Comprehensive Review. Regul Toxicol
Pharmacol. 2017;89:124–130. Available from:
https://doi.org/10.1016/j.yrtph.2015.12.002
5. López-Gil JF, González-Valero G, Izquierdo M, Rodríguez-Rodríguez F,
Ortega FB. Effects of Caffeine on Physical Fitness in Adolescents: A
Randomized Crossover Study. Nutrients. 2022;14(8):1661. Available from:
https://doi.org/10.3390/nu14081661
6. Noh Y, Choi Y, Hwang Y, Kang M. Caffeine Intake and Cardiometabolic
Outcomes in Children and Adolescents: A Systematic Review. Int J Food Sci
Nutr. 2023;36(3):42-56. Available from:
https://doi.org/10.1016/j.bjoms.2023.01.007
7. Izquierdo M, Rodríguez-Rodríguez F, García-Hermoso A, López-Gil JF.
Effects of Habitual Caffeine Consumption on Health-Related Outcomes in
Older Adults. Nutrients. 2023;16(21):3692. Available from:
https://doi.org/10.3390/nu16213692
8. Fernández-Santos JR, García-Hermoso A, Ortega FB, Izquierdo M. Caffeine
Supplementation and Physical Performance in Women: A Systematic Review.
Nutrients. 2023;16(21):3611. Available from:
https://doi.org/10.3390/nu16213611
19
9. Temple JL, Ziegler AM. Effects of Caffeine on Appetite, Energy Intake, and
Body Weight: A Systematic Review. Crit Rev Food Sci Nutr.
2022;62(19):5251-63. Available from:
https://doi-org.ufs.idm.oclc.org/10.1080/10408398.2022.2074362
10. Beltran-Valls MR, García-Hermoso A, Izquierdo M, Tully MA, García-García
FJ. Association of Caffeine Intake with Physical Performance and Sarcopenia
in Older Adults: A Cross-Sectional Study. Nutrients. 2023;16(18):3155.
Available from: https://doi.org/10.3390/nu16183155
11. Hübner C, Volk N, Reichel JL, Zimmermann J, Niklewski G, Quirin M. Why do
you drink caffeine? The development of the motives for caffeine consumption
questionnaire (MCCQ) and its relationship with gender, age and the types of
caffeinated beverages. Int J Ment Health Addiction. 2018;16(4):1023-1036.
doi:10.1007/s11469-017-9822-3.
12. Evans J, Richards JR, Battisti AS. Caffeine. [Updated 2024 May 29]. In:
StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-.
Available from: https://www.ncbi.nlm.nih.gov/books/NBK519490/
13. Jones A, Remmerswaal D, Verveer I, Robinson E, Franken IH, Wenmackers
S, Wiers RW. Compliance with low-risk drinking guidelines: The influence of
psychosocial factors and alcohol consumption patterns. Drug Alcohol Depend.
2012;123(1-3):86-92. doi:10.1016/j.drugalcdep.2012.01.009.
14. Choi SW, Kim YW, Lee CY, Jang HS, Chae HS, Choi JH, Ko YH. Caffeine
consumption of medical students in Korea: amount and symptoms based on a
2023 survey. Korean J Med Educ. 2024;36(3):267-274.
doi:10.3946/kjme.2024.301.
15. Asadi-Pooya AA, Zeraatpisheh Z, Rostaminejad M, Mirzaei Damabi N.
Caffeinated drinks, fruit juices, and epilepsy: A systematic review. Acta Neurol
Scand. 2022;145(2):127-138. doi:10.1111/ane.13544.
16. Dillon P, Kelpin S, Kendler K, Thacker L, Dick D, Svikis D. Gender differences
in any-source caffeine and energy drink use and associated adverse health
behaviors. J Caffeine Adenosine Res. 2019;9(1):15-19.
doi:10.1089/caff.2018.0008.
20
19. Van Rooyen L. R., Laher A. E. Stimulant use among prehospital emergency
care personnel in Gauteng Province, South Africa. South African Medical
Journal (2021) doi: 10.7196/SAMJ.2021.v111i6.15465 Available from:
https://pubmed.ncbi.nlm.nih.gov/34382572/
20. SARS. Rates per kilometer; 2024 Available from:
https://www.sars.gov.za/tax/employers/rates-per-kilometer/
21
ADDENDUMS
Curriculum Vitaes:
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
TRREE Certificates:
42
43
44
45
46
47
48
49
50
Cover Letter:
Ms Marlé van der Merwe
2 Syffer Avenue
Bainsvlei
Bloemfontein
9301
04/03/2025
The Chair: Health Sciences Research Ethics Committee
Block D, Rooms D115 and D112,
Francois Retief Building
Enclosed please find the above research protocol for your evaluation and approval.
We look forward to hearing from you
Yours faithfully,
Marlé van der Merwe
MvdM
2025023934@ufs4life.ac.za
072 349 3648
51
Information document
Dear participant,
This MSSM module group from the faculty of Health Sciences of UFS is conducting
an undergraduate research study and you are invited to participate.
The objective of this study is to determine the average daily caffeine intake of
doctors in all clinical departments of the Bloemfontein hospital complex as well as
the effects of caffeine consumption.
The results of this study will raise awareness of the dangers of caffeine
overconsumption in doctors as well as the sources thereof.
Agreement to participate in this study also includes using the information obtained
for research and publication purposes. The data collected will be stored safely.
Non-participation will not be held against you in any way and participants may
withdraw from this study at any given moment during the completion of the
questionnaire with no penalty.
52
Please take note that your completion of this questionnaire implies that you have
read and understand informed consent.
Thank you for participating in this study. If you have any questions or want to report
any unethical conduct of the researchers, feel free to do so by contacting the
following people:
2025023934@ufs4life.ac.za nadia.vonwielligh@gmail.com
+27 51 401 2352
Questionnaire:
1. Age:
☐ Under 30
☐ 31-40
☐ 41-50
☐ 51-60
☐ 61 and above
2. Gender:
☐ Male
☐ Female
☐ Other
☐ Prefer not to say
3. Designation
☐ Intern
☐ Medical officer
☐ Registrar
☐ Consultant
4. Years of Practice:
☐ 1-5 years
☐ 6-10 years
☐ 11-20 years
☐ 21+ years
54
Anaesthesiology
Cardiology
Cardiothoracic Surgery
Clinical Imaging Sciences
Critical Care
Dermatology
Family Medicine
Internal Medicine
Neurology
Neurosurgery
Nuclear Medicine
Obstetrics and Gynaecology
Oncology
Ophthalmology
Orthopaedics
Otorhinolaryngology
Paediatrics and Child Health
Plastic Surgery
Psychiatry
Surgery
Urology
☐ Other (Please specify): ___________________________
55
7. At what time of day do you typically consume caffeine? (Select all that apply)
☐ Morning
☐ Afternoon
☐ Evening
☐ I do not have a specific time
9. Do you think that you are above, below or in line with the RDA value?
☐ Above
☐ Below
☐ In line with
56
11. How do you perceive the role of caffeine in your daily work routine?
☐ Essential for alertness
☐ Helpful, but not essential
☐ Occasionally helpful
☐ I could function without it
☐ Not sure
57
13. How do you think caffeine affects your body and mind? (Select all that
apply)
☐ Increases alertness
☐ Improves focus and concentration
☐ Causes jitteriness or anxiety
☐ Disrupts sleep
☐ Improves mood
☐ Decreases fatigue
☐ Causes digestive issues (e.g., acid reflux)
☐ Other (Please specify): ___________________________
5 Overconsumption:
- Insomnia
- Anxiety/Agitation
- Frequent urination
- Gastrointestinal distress
- Cardiac Arrhythmias
5 Benefits:
58
15. Have you noticed any negative effects from your caffeine consumption?
☐ Yes
☐ No
☐ Unsure
If yes, please describe:
_______________________________________________________________
59
17. In your opinion, how does caffeine affect your cognitive abilities (e.g.,
memory, focus, decision making) during long shifts?
☐ Significantly improves
☐ Somewhat improves
☐ No effect
☐ Somewhat hinders
☐ Significantly hinders
18. Do you use caffeine during stressful situations or long working hours (e.g.,
during on-call shifts, emergency surgeries)?
☐ Yes, regularly
☐ Occasionally
☐ Rarely
☐ Never
60
20. If yes, what was the reason for trying to reduce or stop? (Select all that
apply)
☐ Health concerns (e.g., anxiety, sleep issues)
☐ To improve focus or performance
☐ Recommended by a healthcare professional
☐ Other (Please specify): ___________________________
21. If you have reduced or stopped caffeine consumption, what effects did you
experience? (Select all that apply)
☐ Increased energy levels without caffeine
☐ Improved sleep quality
☐ Reduced anxiety or jitteriness
☐ No noticeable change
☐ Other (Please specify): _________________________
61
Redcap Questionnaire:
62
63
64
65
Permission Letters:
66
67
68
69
Application Letter
The application letter to HSREC will be attached after submitting the
Gatekeepers application on RIMS.