Condition category
Not Applicable
Date applied
05/01/2021
Date assigned
08/01/2021
Last edited
08/01/2021
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jayaram Thimmapuram

ORCID ID

https://orcid.org/0000-0002-3189-3863

Contact details

2780
Meadow cross Way
York
17402
United States of America
+1 717-851-2345
drthimmapuram@yahoo.com

Additional identifiers

EudraCT number

Nil Known

ClinicalTrials.gov number

Nil Known

Protocol/serial number

IRB number 1568071-3

Study information

Scientific title

Effect of heartfulness meditation on loneliness and sleep in physicians and advance practice providers during COVID-19

Acronym

Study hypothesis

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

Approved 06/07/2020, Wellspan IRB (1001, S George St, York, Pennsylvania - 17403, USA; +1 717 8512223; irb@wellspan.org), ref: 1568071-3

Study design

Single institutional randomized controlled prospective study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

No participant information sheet available

Condition

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

Phase

Drug names

Primary outcome measure

1. Loneliness measured using UCLA Loneliness score at baseline and 4 weeks
2. Sleep was assessed using the Pittsburgh Sleep Quality Index at baseline and 4 weeks

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

20/02/2020

Overall trial end date

12/10/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Any employee who is a physician or an advance practice provider willing to participate

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

100 in each group

Total final enrolment

155

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

21/07/2020

Recruitment end date

10/08/2020

Locations

Countries of recruitment

United States of America

Trial participating centre

Wellspan Health
1001, S George St
York
17403
United States of America

Sponsor information

Organisation

WellSpan Health

Sponsor details

1001
S George St
York
17403
United States of America
+1 717-851-2223
irv@wellspan.org

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

30/09/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

08/01/2021: Trial’s existence confirmed by Wellspan Health.