Effect of virtual heartfulness meditation and yoga program on mental wellbeing
| ISRCTN | ISRCTN83713102 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83713102 |
| Secondary identifying numbers | IRB 07171 |
- Submission date
- 07/02/2022
- Registration date
- 09/02/2022
- Last edited
- 08/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background & study aims
Yoga and meditative practices are known to significantly improve psychological well-being. The practice of yoga produces a physiological state opposite to that of the flight-or-fight stress response and with that interruption in the stress response, a sense of balance and union between the mind and body can be achieved. Heartfulness is a simple heart-based meditation practice supported by yogic transmission aimed to achieve an inner state of balance. Prior literature on heartfulness meditation has demonstrated favorable outcomes in improving burnout, emotional wellness, sleep quality, and perception of loneliness. The virtual approach to wellbeing has become popular during the pandemic and has been well utilized.
The current study aims to assess the effects of a virtual yoga and meditation program on measures of anxiety, loneliness, and satisfaction with life.
Who can participate?
Any adult 18 years of age and above residing in the United States of America can participate in the study.
What does the study involve?
It requires attending a virtual training webinar session conducted by certified yoga and meditation trainers comprising yoga exercises followed by heartfulness relaxation and meditation once a week for six weeks. The participants will be asked to practice daily the techniques suggested in weekly virtual sessions and also to self-report the adherence to the intervention in the same survey at the end of the study period.
What are the possible benefits and risks of participating?
Learning yoga, relaxation, and meditation skills that are part of this study may help an individual cope with stress better. It may also help one sleep better. There may be bodily discomfort through sitting for a prolonged period or doing yogic exercises. One can also have the experience of unwanted emotion and thoughts arising and passing during the meditation.
Where is the study run from?
The study will be run through a virtual platform and email communication from Dayton, Ohio, USA.
Where is the study starting and how long is it expected to run from?
November 2021 to March 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Kunal Desai, MD
kunal.desai@wright.edu
Contact information
Principal Investigator
33 West Rahn Road
Dayton
45429
United States of America
 ORCID ID |
0000-0002-4959-8061 |
|---|---|
| Phone | +1 9374338990 |
| kunal.desai@wright.edu |
Study information
| Study design | Prospective pre-post intervention single-arm study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Internet/virtual |
| Study type | Quality of life |
| Participant information sheet | No participant information sheet available |
| Scientific title | Effect of virtual heartfulness meditation and yoga program on anxiety, loneliness, and satisfaction with life in the general US population |
| Study objectives | Intervention of heartfulness meditation practices and yoga may be associated with reduction in anxiety levels, reduction in perception of loneliness and improvement in satisfaction with life. |
| Ethics approval(s) | Approved 30/11/2021, Wright State University IRB (3640 Colonel Glenn Hwy, Dayton, OH 45435-0001, USA; +1 937-775-4462; whitney.mcallister@wright.edu), ref: #07171 |
| Health condition(s) or problem(s) studied | Studying impact of meditation and yoga on anxiety, loneliness and satisfaction with life |
| Intervention | The study participants will be offered education & training of yoga exercises and heartfulness meditation practice by certified yoga and meditation trainers on a virtual platform over 6-week period. |
| Intervention type | Behavioural |
| Primary outcome measure | Measured at baseline and post intervention at the end of 6 weeks: 1. Generalized anxiety measured by GAD-7 scale 2. Loneliness measured by UCLA Loneliness scale 3. Satisfaction with life measured by Satisfaction with life scale |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 30/11/2021 |
| Completion date | 13/03/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 90 |
| Total final enrolment | 73 |
| Key inclusion criteria | 1. Adults above 18 years of age with an interest to participate in the study 2. 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 or uncontrolled psychiatric conditions 2. Participants with a history of meditation practice (≥ 100 hours of meditation) will be excluded from the study to avoid participant bias Disclaimer: 1. Any person under medical care for depression or other mental health conditions are encouraged not to participate or to only participate after discussion with his/her healthcare provider, so that the study participation does not interfere with current treatment. 2. Any person with physical limitation to perform yoga exercises are advised to seek guidance from his/her healthcare provider, so that study participation does not interfere with current treatment and does not put oneself at risk of any physical injury. |
| Date of first enrolment | 02/01/2022 |
| Date of final enrolment | 04/02/2022 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Dayton
45435
United States of America
Sponsor information
University/education
3640 Colonel Glenn Hwy
Dayton
45435
United States of America
| Phone | +1 937-775-3974 |
|---|---|
| jodi.blacklidge@wright.edu | |
| Website | http://www.wright.edu/ |
"ROR" |
https://ror.org/04qk6pt94 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study will be stored in a non-publicly available repository, will be stored with Wright State University secured resources. |
Editorial Notes
08/09/2023: The intention to publish date has been changed from 01/09/2023 to 31/12/2023.
09/09/2022: The intention to publish date has been changed from 28/09/2022 to 01/09/2023.
09/02/2022: Trial's existence confirmed by Wright State University IRB.
