Effect of heartfulness meditation on loneliness and sleep in physicians and advance practice providers
| ISRCTN | ISRCTN85787008 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85787008 |
| ClinicalTrials.gov (NCT) | Nil Known |
| Clinical Trials Information System (CTIS) | Nil Known |
| Protocol serial number | IRB number 1568071-3 |
| Sponsor | WellSpan Health |
| Funder | Investigator initiated and funded |
- Submission date
- 05/01/2021
- Registration date
- 08/01/2021
- Last edited
- 09/03/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Loneliness poses a significant health problem for a sizeable part of the population with increased risks in terms of depression, anxiety, suicidal ideation, health behavior and health care utilization. The medical profession is reported to be one of the loneliest professions of all.
Perception of loneliness can also be influenced by the relationship to one’s own self and sleep. Wellness events and meditation practices may have a positive impact on burnout. Heartfulness meditation practice has been shown to improve wellbeing and sleep. Heartfulness meditation is a simple heart-based meditation system aimed at attaining a balanced state of mind by asking the participants to focus on the source of light within the heart. This study will investigate whether using this novel approach of a heart-based meditation program leads to measurable changes in improvement of sleep and perception of loneliness in physicians and advance practice clinicians.
Who can participate?
All physicians and advance practice providers of Wellspan
What does the study involve?
A survey monkey questionnaire with baseline characteristics and PSQI questionnaire and UCLA loneliness scale will be sent to all physicians and APCs of Wellspan from the research department. Those who respond to the survey will be included in the study. Those willing to participate in mediation program to improve sleep will be randomized into two groups. One group receives instructions whereas the other group does not. A repeat UCLA loneliness and PSQI questionnaires will be sent to the initial respondents and divided into meditation group and the control group and the no interest group. Data from participants who complete survey questions will be collected at the baseline and intervention weeks respectively.
What are the possible benefits and risks of participating?
Participants who complete the meditation session may be able to have an improvement of sleep and/or perception of loneliness. Stress and burnout along with sleep and loneliness scores may be improved as the subjects become less reactive to worrisome thoughts.
Some of the participants may have no benefit from meditation. As this is voluntary participation, it may take around 15 minutes of the participant’s time per day during the intervention period.
Where is the study run from?
Wellspan Health (USA)
When is the study starting and how long is it expected to run for?
February 2020 to October 2020
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Jayaram Thimmapuram, drthimmapuram@yahoo.com
Contact information
Scientific
2780, Meadow cross Way
York
17402
United States of America
 ORCID ID |
0000-0002-3189-3863 |
|---|---|
| Phone | +1 717-851-2345 |
| drthimmapuram@yahoo.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single institutional randomized controlled prospective study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effect of heartfulness meditation on loneliness and sleep in physicians and advance practice providers during COVID-19 |
| Study objectives | 1. There is a high burden of loneliness in physicians and advance practice clinicians 2. PSQI scores will correlate with scores of loneliness (poor sleep with higher loneliness) 3. Heartfulness meditation practice will be associated with subjects’ improved sleep and loneliness scores |
| Ethics approval(s) | Approved 06/07/2020, Wellspan IRB (1001, S George St, York, Pennsylvania - 17403, USA; +1 717 8512223; irb@wellspan.org), ref: 1568071-3 |
| Health condition(s) or problem(s) studied | Loneliness and sleep in physicians and advance practice providers |
| Intervention | After the enrollment of the participants through email surveys, computerized randomization was performed. Heartfulness Meditation Audio links were provided to the Heartfulness meditation group to perform meditation for 15 minutes per day for 4 weeks. The control group continued with their usual routine. Assessments were made at baseline and 4 weeks. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Loneliness measured using UCLA Loneliness score at baseline and 4 weeks |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 12/10/2020 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 200 |
| Total final enrolment | 155 |
| Key inclusion criteria | Any employee who is a physician or an advance practice provider willing to participate |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 21/07/2020 |
| Date of final enrolment | 10/08/2020 |
Locations
Countries of recruitment
- United States of America
Study participating centre
York
17403
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 17/03/2021 | 09/03/2021 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
09/03/2021: Publication reference added.
08/01/2021: Trial’s existence confirmed by Wellspan Health.
