Effects of Heartfulness meditation on the wellbeing of Indian physicians and medical students
| ISRCTN | ISRCTN42711866 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42711866 |
- Submission date
- 30/06/2023
- Registration date
- 04/07/2023
- Last edited
- 12/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Healthcare providers, including medical students and physicians, encounter notable challenges regarding burnout and loneliness, posing detrimental effects on their well-being and patient care. Physicians of Indian origin in the United States specifically face higher burnout levels than their counterparts. In India, medical students and physicians also confront substantial challenges concerning burnout and loneliness. Considering the potential benefits of meditation in mitigating stress and burnout among healthcare providers, including physicians and medical students, it is crucial to investigate its impact on these populations. The Heartfulness meditation practice, a specific method of meditation, has been shown to decrease loneliness, improve sleep, and reduce burnout in healthcare workers. This study aims to investigate the impacts of a virtual, heart-based meditation program (Heartfulness practice) on the Indian medical student and physician populations in India and the Indian physician population in the United States.
Who can participate?
Physicians of Indian origin residing in the United States, physicians and medical students residing in India
What does the study involve?
After baseline surveys are completed, physicians are randomly allocated into the intervention group and the control group for a 4-week intervention considered Phase I of the study. The intervention group will participate in the Virtual Heartfulness meditation program, which will include one orientation session, three education and guided relaxation and meditation sessions over three consecutive days, three weekly group education and meditation sessions and daily self-paced meditation practices. In addition, the Heartfulness trainer-guided virtual sessions will be offered which will be conducted daily, 5 days a week for the duration of the study period by Heartfulness trainer and primary investigator Dr Kunal Desai or other Heartfulness trainers only via Webinar mode to maintain the privacy of the participants. Heartfulness trainers will be assigned to participants and will offer individual guided sessions twice a week during the study period.
The control group will not partake in any programming and will continue with regular daily activities. At the end of the 4 weeks, all participants will be required to complete surveys.
At the end of the first 4-week intervention, emails will be sent to all participants asking for voluntary participation in Phase II of the study. The control group will be invited to participate in the same 4-week Heartfulness meditation program mentioned above. The intervention group will be invited to continue to participate in the program, with an opportunity to complete a total 8-week program. At the end of the 8 weeks, all participants will be required to complete surveys.
All participants in both groups will be provided with information, including recorded video presentations for Heartfulness meditation practice, at the end of the 8 weeks.
What are the possible benefits and risks of participating?
Participants who complete the Heartfulness meditation program may experience reduced burnout and may have an improved sense of emotional wellness and improvement in satisfaction with life.
In the practice of meditation, although calmness is induced, there can also be the experience of unwanted emotions and thoughts arising and passing. There may also be bodily discomfort through sitting for a prolonged period.
Where is the study run from?
Wright State University (USA)
When is the study starting, and how long is it expected to run for?
January 2023 to April 2025
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Kunal Desai, kunal.desai@wright.edu
Contact information
Principal Investigator
128 E Apple St Wche 2
Dayton
45409
United States of America
| Phone | +1 (0)9374338990 |
|---|---|
| kunal.desai@wright.edu |
Study information
| Study design | Prospective randomized controlled crossover study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Internet/virtual |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Impact of Heartfulness meditation practices on burnout, loneliness, and satisfaction with life among Indian physicians and medical students: a randomized controlled survey study |
| Study objectives | Heartfulness meditation practice may reduce burnout and loneliness and increase satisfaction with life among Indian physicians and medical students. |
| Ethics approval(s) |
Approved 26/06/2023, Wright State University Institutional Review Board (3640 Colonel Glenn Highway, Dayton, 45435, United States of America; +1 (0)937 775 4462; irb-rsp@wright.edu), ref: IRB-2023-309 |
| Health condition(s) or problem(s) studied | Burnout and loneliness |
| Intervention | The baseline survey will obtain demographic information, detailed in the Participant Detail Form, as well as responses to the UCLA 3-Item Loneliness Scale (ULS-3), the abbreviated Maslach Burnout Inventory (aMBI), and Satisfaction with Life (SWLS). After baseline surveys are completed, physicians interested in study participation will be separated, through computerized randomization, into the intervention group and the control group for a 4-week intervention considered Phase I of the study. The intervention group will participate in the Virtual Heartfulness meditation program, which will include one orientation session, three education and guided relaxation and meditation sessions over three consecutive days, three weekly group education and meditation sessions and daily self-paced meditation practices. In addition, the Heartfulness trainer-guided virtual sessions will be offered which will be conducted daily, 5 days a week for the duration of the study period by Heartfulness trainer and primary investigator Dr. Kunal Desai or other Heartfulness trainers only via Webinar mode to maintain the privacy of the participants. Heartfulness trainers will be assigned to participants and will offer individual guided sessions twice a week during the study period. This will help reduce the attrition observed in the previous studies. The control group will not partake in any programming and will continue with regular daily activities. At the end of the 4 weeks, all participants will be required to complete the Phase I Completion survey that includes the ULS-3, aMBI, and SWLS reassessments. Additionally, the intervention group participants will be required to complete the Qualitative Feedback Survey and Practice Frequency Survey. Upon completion of the first 4-week intervention, email communication will be sent to all participants asking for voluntary participation in Phase II of the study. The control group will be invited to participate in the same 4-week Heartfulness meditation program mentioned above. The intervention group will be invited to continue to participate in the program, with an opportunity to complete a total 8-week program. At the end of the 8 weeks, all participants will be required to complete the Qualitative Feedback Survey, Practice Frequency Survey, and Phase II Completion Survey that includes ULS-3, aMBI, and SWLS reassessments. All participants in both groups will be provided with information, including recorded video presentations for Heartfulness meditation practice, at the end of the 8 weeks. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Loneliness measured using the UCLA 3-Item Loneliness Scale (ULS-3) at baseline, week 4 and week 8 2. Burnout measured using the abbreviated Maslach Burnout Inventory (aMBI) at baseline, week 4 and week 8 3. Satisfaction with life measured using the Satisfaction with Life (SWLS) at baseline, week 4 and week 8 |
| Secondary outcome measures | Subjective experience measured using qualitative questions at baseline, week 4 and week 8 |
| Overall study start date | 09/01/2023 |
| Completion date | 01/04/2025 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 600 |
| Key inclusion criteria | 1. Adults above 18 years of age are willing to participate in the study 2. Physicians of Indian origin residing in the United States 3. Physicians residing in India and medical students enrolled medical schools in India 4. Requires basic knowledge of the Internet and ability to follow instructions regarding email communications as well as accessing video conferences |
| Key exclusion criteria | 1. Individuals less than 18 years of age 2. Participants with a history of meditation practice (≥100 hours of meditation) will be excluded from the study to avoid participant bias 3. Any person under medical care for depression or other mental health conditions is encouraged not to participate or only participate after discussion with his/her healthcare provider so that the study participation does not interfere with current treatment |
| Date of first enrolment | 01/02/2025 |
| Date of final enrolment | 01/03/2025 |
Locations
Countries of recruitment
- India
- United States of America
Study participating centre
United States of America
Sponsor information
University/education
3640 Colonel Glenn Highway
Dayton
45435
United States of America
| Phone | +1 (0)937 775 4462 |
|---|---|
| irb-rsp@wright.edu | |
| Website | http://www.wright.edu/irb |
"ROR" |
https://ror.org/04qk6pt94 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The researchers expect to publish the study results and manuscript in a PubMed-indexed journal. |
| IPD sharing plan | The datasets generated and/or analyzed during the current study are unknown and will be made available at a later date. |
Editorial Notes
12/09/2024: The following changes were made to the trial record:
1. The recruitment start date was changed from 15/07/2023 to 01/02/2025.
2. The recruitment end date was changed from 31/08/2023 to 01/03/2025.
3. The overall end date was changed from 21/10/2023 to 01/04/2025.
4. The intention to publish date was changed from 28/09/2024 to 01/09/2025.
5. The plain English summary was updated to reflect these changes.
03/07/2023: Study's existence confirmed by the Wright State University Institutional Review Board.
