Impact of Heartfulness meditation practices compared to the Gratitude practice on compassion fatigue and burnout
| ISRCTN | ISRCTN15778488 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15778488 |
| Secondary identifying numbers | IRB 07187 |
- Submission date
- 11/04/2022
- Registration date
- 12/04/2022
- Last edited
- 17/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
While involved in the noble profession of helping fellow human beings, healthcare workers are exposed to a challenging work environment where they encounter distressed patients and families. Compassion and empathy are expected of all healthcare professionals though this constant demand can become overwhelming depending on the work environment, patient population, and workload. Heartfulness is a simple heart-based meditation practice supported by yogic transmission aimed to achieve an inner state of balance. Research 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 American Nurses Foundation and the Greater Good Science Center (GGSC) at the University of California, Berkeley, have developed a Gratitude Practice for Nurses Toolkit to support nurses’ social and emotional wellbeing. It is unclear if gratitude improves compassion fatigue and burnout and improves mental wellbeing, especially for healthcare workers, including nurses, as limited research data from randomized studies is available in this population. This study will investigate whether heartfulness meditation practice leads to measurable changes in compassion fatigue, compassion satisfaction and burnout among the nurses and allied healthcare providers compared to Gratitude practice.
Who can participate?
Any adult aged 18 years or over who works as a nurse or an allied healthcare worker providing patient care in Premier Health Network clinical sites in Dayton, Ohio.
What does the study involve?
The participants will be randomly assigned to one of the two study groups: group 1: the Heartfulness meditation group OR group 2: the Gratitude practice group. They will be asked to attend virtual trainer guided Heartfulness relaxation and meditation sessions at least four times a week for 6 weeks if they are in Group 1. They will be asked to attend education sessions regarding the Gratitude practice once a week if they are in Group 2. They will be asked to practice daily the techniques suggested in weekly virtual sessions. They will also be asked to self-report their 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 gratitude practice or relaxation and meditation skills that are part of this study may help the participants cope with stress better. It may also help them sleep better. Participants may experience unwanted emotions and thoughts arising and passing during the meditation.
Where is the study run from?
Wright State University (USA)
When is the study starting and how long is it expected to run from?
August 2021 to October 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 (0)9374338990 |
| kunal.desai@wright.edu |
Study information
| Study design | Prospective randomized control study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled 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 compared to the Gratitude practice on compassion fatigue, compassion satisfaction and burnout for nurses and allied healthcare professionals: a randomized trial |
| Study hypothesis | A 6-week virtual Heartfulness meditation program will reduce the burden of compassion fatigue and burnout for nurses and allied healthcare professionals when compared with the Gratitude practice. |
| Ethics approval(s) | Approved 28/01/2022, Wright State University IRB (3640 Colonel Glenn Hwy, Dayton, OH 45435-0001, USA; +1 (0)937 775 4462; whitney.mcallister@wright.edu), ref: #07187 |
| Condition | Compassion fatigue and burnout among the nurses and allied healthcare providers |
| Intervention | The participants will be randomly assigned to one of the two study groups: Group 1: Heartfulness meditation group Group 2: Gratitude practice group The researchers will be using an adaptive recruitment strategy with randomization at the end of recruitment with a plan to randomly assign 70% of participants to the Heartfulness meditation practice group (considering the high attrition rate in past meditation studies) and 30% to the self-motivated Gratitude practice arm. The researchers will be using a basic method of simple randomization (flipping a coin). Participants will be asked to attend virtual trainer guided Heartfulness relaxation and meditation sessions at least four times a week for 6 weeks in Group 1. They will be asked to attend education sessions regarding the Gratitude practice once a week in Group 2. They will be asked to practice daily the techniques suggested in weekly virtual sessions. They will also be asked to self-report their adherence to the intervention in the same survey at the end of the study period. |
| Intervention type | Behavioural |
| Primary outcome measure | Measured at baseline and post-intervention at the end of 6 weeks, 3 months and 6 months: 1. Compassion fatigue, compassion satisfaction and burnout measured using the Professional Quality of Life Scale-5 (ProQOL-5) 2. The testimonials or descriptive answers to the open-ended qualitative questions |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 21/08/2021 |
| Overall study end date | 31/10/2022 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 300 |
| Total final enrolment | 83 |
| Participant inclusion criteria | 1. Adults above 18 years of age willing to participate in the study 2. Nurse or an allied healthcare worker actively employed by Premier Health Network 3. Requires basic knowledge of the Internet and the ability to follow instructions regarding email communications as well as accessing video conferences |
| Participant exclusion criteria | Individuals less than 18 years of age Disclaimer: 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. |
| Recruitment start date | 11/04/2022 |
| Recruitment end date | 28/04/2022 |
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
45429
United States of America
| Phone | +1 (0)937 775 3974 |
|---|---|
| whitney.mcallister@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 | 02/04/2024 |
|---|---|
| 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 with Wright State University provided secured Proofpoint Secure Share. When the study is completed and the data have been analyzed, all code lists linking names to study numbers will be destroyed. This is expected to occur no later than 1 year. This informed consent form will be kept for 5 years after the study is complete, and then it will be destroyed. This is approved by the Wright State University IRB/ethics committee. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 07/06/2024 | 17/06/2024 | Yes | No |
Editorial Notes
17/06/2024: Publication reference added.
08/09/2023: The intention to publish date was changed from 04/03/2023 to 02/04/2024.
06/02/2023: The intention to publish date was changed from 04/02/2023 to 04/03/2023. Total final enrolment added.
27/05/2022: The sponsor contact details have been updated.
12/04/2022: Trial's existence confirmed by the Wright State University IRB.
