CTRI/2024/01/061193 [Registered on: 08/01/2024] Trial Registered Prospectively
Last Modified On:
03/01/2024
Post Graduate Thesis
Yes
Type of Trial
Observational
Type of Study
Cross Sectional Study
Study Design
Other
Public Title of Study
Do Psychosocial risk factors affect the Quality of Life of Healthcare Professionals?
Scientific Title of Study
The relationship between psychosocial risk factors, burnout and quality of life
among healthcare professionals in a multi-specialty tertiary care hospital in coastal Karnataka.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Vaishnavi Dhanya
Designation
Masters in Hospital Administration, Student
Affiliation
Prasanna School of Public Health
Address
Room NO. LH3, Department of Social and Health Innovation, Prasanna School of Public Health, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka
Udupi KARNATAKA 576104 India
Phone
8511354565
Fax
Email
vaishnavi.psphmpl2022@learner.manipal.edu
Details of Contact Person Scientific Query
Name
Dr Swathi KS
Designation
Associate Professor, Department of Social and Health Innovation
Affiliation
Prasanna School of Public Health
Address
Department of Social and Health Innovation, Prasanna School of Public Health, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka
Udupi KARNATAKA 576104 India
Phone
9481749911
Fax
Email
swathi.ks@manipal.edu
Details of Contact Person Public Query
Name
Dr Swathi KS
Designation
Associate Professor, Department of Social and Health Innovation
Affiliation
Prasanna School of Public Health
Address
Department of Social and Health Innovation, Prasanna School of Public Health, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka
Udupi KARNATAKA 576104 India
Phone
9481749911
Fax
Email
swathi.ks@manipal.edu
Source of Monetary or Material Support
Prasanna School of Public Health, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Primary Sponsor
Name
VAISHNAVI DHANYA
Address
Prasanna School of Public Health, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Type of Sponsor
Other [Self]
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Swathi K S
Kasturba Hospital
Room no.56, Department of General Medicine, Udupi,
Karnataka 576104 Udupi KARNATAKA
9481749911
swathi.ks@manipal.edu
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research)
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Not applicable
Intervention / Comparator Agent
Type
Name
Details
Intervention
NIL
NIL
Inclusion Criteria
Age From
20.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
The study includes all the participants
comprising of doctors and nurses of all the different clinical departments who are willing to respond to the study.
ExclusionCriteria
Details
The interns of MBBS of the hospital are excluded from the study.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
The researcher conducts the study to find out the perception of healthcare
professionals on their quality of life.
10 to 12 weeks
Secondary Outcome
Outcome
TimePoints
NIL
NIL
Target Sample Size
Total Sample Size="325" Sample Size from India="325" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
15/01/2024
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="3" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Protocol (Description of the Project)
1. Title of the project: The relationship between psychosocial risk factors, burnout and quality of life
among healthcare professionals in a multi-specialty tertiary care hospital in coastal Karnataka.
2. Type of Study: Prospective study- cross sectional study
3. Aims & objectives: Aim- The study aims to assess the association between psychosocial risk
factors, burnout and quality of life among healthcare professionals in a multi-specialty tertiary care
hospital.
Objectives- i. To assess the relationships between psychosocial risks factors arising from work, job
stress, burnout
ii. To investigate the impact on perceived quality of life among healthcare professionals in a multispeciality tertiary care hospital.
4. Justification for study: The involvement of the healthcare professionals in their work hours and
their work environment is very much required in the provision of quality of care services. Thus, their
quality-of-life matters in deciding the quality of care. Poor working conditions can have a negative impact
on employees’ health, productivity, and well-being, according to a prior study. Psychosocial risk factors
may also contribute to job dissatisfaction, cognitive stress symptoms, and burnout at work. Therefore, it
is the need of the hour to conduct a study to understand the relationship between psychosocial risk
factors, burnout and quality of life among healthcare professionals as this study will be beneficial for the
policy makers in providing a conducive work environment for the healthcare professionals to perform
their duties.
5. Departments involved: All the clinical departments are involved in the study.
6. Study period: The time required for the study is from September 2023 till May 2024
7. Sample size: The formula for finite population that is used isn =
ð‘ð‘
2ð‘ƒ(1−ð‘ƒ)
ð‘‘2(ð‘−1)+ð‘2ð‘ƒ(1−ð‘ƒ)
, (Daniel WW, 1999)
n =
2093∗(1.96)
20.5(1−0.5)
(0.5)2(2093−1)+(1.96)20.5(1−0.5)
Substituting the values- N=2093
d=0.05
Z=1.96
P=0.5
The value of n=324.7 which is rounded off to 325
The sample size obtained is 325.
8. Materials and methods:
Where,
N=Population Size
Z=level of confidence
P=Expected proportion
D=precision
a) Inclusion and exclusion criteria: Inclusion criteria- The study includes all the participants
comprising of doctors and nurses of all the different clinical departments who are willing to respond to
the study.
Exclusion criteria- The interns of MBBS of the hospital are excluded from the study.
b) Biological materials required (type - blood, tissue etc and quantity): Yes ☠No ☒
i) Biological material: nil.
ii) Biosafety Measures: Not applicable
c) Statistical methods: Descriptive statistical tests and advanced statistics like correlations, T-tests
for independent samples and multiple regression will be performed.
d) Tools used: Structured questionnaires for collecting data and Jamovi statistical software for
analyzing data.
9. Detailed description of procedure / processes: The researcher would be conducting a crosssectional quantitative study which measures the perception of healthcare professionals on burnout and
its impact on their quality-of-life A structured questionnaire will be used and it comes in three parts. The
first part consists of the demographic particulars of the respondents. The second half consists of
questions which measures the quality of life, and the third part measures the psychosocial risk factors.
Quality of life will be evaluated using The World Health Organization Quality of Life Questionnaire
(WHOQOL-BREF) and psychosocial risk factors will be evaluated by the Copenhagen Psychosocial
Questionnaire (COPSOQ). WHO quality of life scale (WHOQOLBREF) consisted of 26 items. The
WHOQOLBREF has four domains: physical, psychological, social and environmental domains. The
COPSOQ has 25 scales with five distinctive domains namely, demands, influence and development,
interpersonal relations and leadership, further parameters and outcome scales. All the questionnaire
questions are measured on a 1-5 Likert scale. The study adopts stratified sampling.
10. Outcome measures: The researcher conducts the study to find out the perception of healthcare
professionals on their quality of life.
11. Potential risks and benefits: Risks-There is minimal risk to the study respondents as it is a
questionnaire based study. However, the researcher assures that the confidentiality of the personal
information would not be disclosed.
Benefit-The results of the study would help the policy makers and administrators to create a conducive
work environment for the health care professionals.
12. Ethical considerations and methods to address issues: The researcher seeks approval for the
study from the Institutional Ethical Committee upon which the study will be conducted.
13. Budget (give details) and proposed funding source: Not applicable
14. Review of literature: The studies related to mental health of healthcare professionals and its
relevance and effect on to their quality of life were reviewed by the researcher to understand with the
help of the database Scopus to identify the study by using the keywords such as†mental health of
doctorsâ€, “healthcare professionalsâ€, “burnout†and “quality of lifeâ€. The Boolean operator AND was used.
The researcher considered Scopus to obtain quality papers. The studies published only in English
literature were considered. The filter for the “type of document†was restricted to Article papers. The
years were also filtered to include article papers from the last five years which is from the year 2018 to
2023. The researcher was able to identify 15 relevant studies in relation to the research topic by looking
at the abstract and relevance of the study that were conducted in several countries that highlighted the
attitude of mental health of healthcare professionals and its effect on their quality of life and wellbeing.
Out of the 15 papers that were considered, 13 were of international context while the rest 2 were of
national or Indian significance. The sample size was seen to vary from 21 to 42,942. In many of the
studies, the researchers did a quantitative cross-sectional study and data was collected in the form of a
questionnaire. The respondents’ response was measured in the form of four-to-six-point Likert scale in
most of such papers. However, there were 4 papers out of the 15 that were different in their choice of
methodology. One study in Australia (Cohen et al, 2023) used Systematic Literature Review to
synthesize evidence since 2015 on the impact of interventions designed to address well-being and
burnout in physicians, nurses and allied healthcare professionals. Another study (Sawyer et al, 2023)
implemented the use of Randomized Control Trials to understand the impact of a psychoeducational
group program on the mental well-being of unit-based nurse leaders in Florida. A study conducted in the
Naval Medical Centre San Diego (NMCSD) (Ram et al, 2023) was performed to reduce stress and
burnout in military healthcare professionals through Mind–Body Medicine pilot program. A retrospective
analysis was conducted of data collected from a single-arm prospective MBM pilot program. Finally, a
study in Australia and New Zealand (Bradfield et al, 2023) used qualitative analysis in the form of indepth semi-structured interviews to study Australian and New Zealand doctors’ experiences of
disciplinary notifications, investigations, proceedings and interventions relating to alleged mental health
impairment. All the objectives in the studies considered were similar which was to determine well-being
and turnover rates of physicians and nurses in hospital practice (Aiken et al, 2023), to examine the
prevalence and determinants of symptoms of severe burnout, job strain, and suicidal ideation (Dres et
al, 2021), to measure trends and identify factors associated with physician burnout (Carmen et al, 2019).
Several covid studies were included as the importance to mental health in general was recognized to be
paramount during those years. For example, a study in Republic of Korea investigated the effects of
health care professionals’ viral epidemic-related stress, professional quality of life, depression, and
anxiety on their health-related quality of life (Lee et al, 2019). Most of the data were analyzed
descriptively using means (M) and standard deviations (SD) then with independent sample t-test.
Forward stepwise multiple regression analysis was performed to test the association between the
independent variables and the generally poor quality of life. Some of the key findings of the studies
considered were poor quality of life was observed in 74.6% of healthcare workers surveyed. General
poor quality of life was significantly higher among workers who reported higher burnout (Asante et al,
2019). In a study conducted in France (Dres et al, 2019) 40% of participants reported severe burnout,
12% reported job strain, and 15% reported suicidal ideation. Results from the pilot program in NMCSD
as mentioned earlier suggest that the MBM program has the potential to reduce occupational stress and
burnout and improve well-being in military healthcare professionals (Ram et al, 2023). The RCT study
(Sawyer et al, 2023) adds to evidence that psychoeducational group program can be an effective
intervention for improving and protecting mental wellbeing, specifically among unit-based nurse leaders,
which is a population for which there is a dearth of existing knowledge from cross-sectional and
intervention studies. The important gaps in the literature that need to be addressed are the studies were
conducted during the COVID-19 pandemic when clinician well-being was likely worse than previously,
although research showed high rates of clinician burnout before the pandemic. (Aiken et al, 2023).
Long-term stress effects cannot be determined immediately after the COVID-19 pandemic (Lee et al,
2019). Baseline mental health symptoms and perceptions of the work environment vary across
countries. Considering the wide usability and applicability of the scales, the researcher would be
employing the pre-established and validated WHOQOL-BREF and COPSOQ scales for measuring the
quality of life and psychosocial risk factors respectively. Therefore, much more extensive research and
study must be conducted to understand the Indian context with respect to mental health of health care
professionals as this study will be beneficial for the policy makers in providing a conducive work
environment for the healthcare professionals to perform their duties.
15. References:
1. Asante, J. O., Li, M. J., Liao, J., Huang, Y. X., & Hao, Y. T. (2019). The relationship between
psychosocial risk factors, burnout and quality of life among primary healthcare workers in rural
Guangdong province: a cross-sectional study. BMC health services research, 19(1), 1-10.
2. Aiken, L. H., Lasater, K. B., Sloane, D. M., Pogue, C. A., Rosenbaum, K. E. F., Muir, K. J., ... &
US Clinician Wellbeing Study Consortium. (2023, July). Physician and nurse well-being and
preferred interventions to address burnout in hospital practice: factors associated with
turnover, outcomes, and patient safety. In JAMA Health Forum (Vol. 4, No. 7, pp. e231809-
e231809). American Medical Association.
3. Dres, M., Copin, M. C., Cariou, A., Mathonnet, M., Gaillard, R., Shanafelt, T., ... & Azoulay, E.
(2023). Job Strain, Burnout, and Suicidal Ideation in Tenured University Hospital Faculty Staff
in France in 2021. JAMA Network Open, 6(3), e233652-e233652.
4. Cohen, C., Pignata, S., Bezak, E., Tie, M., & Childs, J. (2023). Workplace interventions to
improve well-being and reduce burnout for nurses, physicians and allied healthcare
professionals: a systematic review. BMJ open, 13(6), e071203.
5. Sawyer, A. T., Tao, H., & Bailey, A. K. (2023). The Impact of a Psychoeducational Group
Program on the Mental Well-Being of Unit-Based Nurse Leaders: A Randomized Controlled
Trial. International Journal of Environmental Research and Public Health, 20(11), 6035.
6. Mathew, L., & Gupta, A. (2023). Professional Quality of Life (ProQOL) of Health Care
Providers in Manipur, India. National Journal of Community Medicine, 14(04), 256-259.
7. Karanjkar, A., Panse, N., Panse, S., & Sahasrabudhe, P. (2023). Indian Perspective of Burnout
Among Plastic Surgeons. Indian Journal of Plastic Surgery, 56(02), 153-158.
8. Lee, Y. J., Yun, J., & Kim, T. (2023). Stress-and work-related burnout in frontline health-care
professionals during the COVID-19 pandemic. Disaster medicine and public health
preparedness, 17, e38.
9. Ram, V., Bhakta, J. P., Roesch, S., & Millegan, J. (2023). Reducing Stress and Burnout in
Military Healthcare Professionals Through Mind–Body Medicine: A Pilot Program. Military
Medicine, 188(5-6), e1140-e1149.
10. Bradfield, O., Jenkins, K., Spittal, M., & Bismark, M. (2023). Australian and New Zealand
doctors’ experiences of disciplinary notifications, investigations, proceedings and interventions
relating to alleged mental health impairment: A qualitative analysis of interviews. International
Journal of Law and Psychiatry, 86, 101857.
11. Del Carmen, M. G., Herman, J., Rao, S., Hidrue, M. K., Ting, D., Lehrhoff, S. R., ... & Ferris, T.
G. (2019). Trends and factors associated with physician burnout at a multispecialty academic
faculty practice organization. JAMA network open, 2(3), e190554-e190554.