Sleep patterns in internal medicine resident physicians and the effect of heartfulness meditation
| ISRCTN | ISRCTN16871934 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16871934 |
| Secondary identifying numbers | 1040076-6 |
- Submission date
- 24/02/2021
- Registration date
- 04/03/2021
- Last edited
- 09/06/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Resident physicians have a high level of burnout and stress. Adequate sleep is essential for resident wellbeing. Interventional studies on resident sleep patterns are scant. The current study aims to measure the sleep patterns of resident physicians during 1 week of outpatient rotation using a consensus sleep diary (CSD) and actigraphy watches during baseline week and assess the impact of Heartfulness meditation on these parameters during the intervention week.
Who can participate?
All eligible internal medicine resident physicians at Wellspan York Hospital.
What does the study involve?
The study involves filling a CSD daily and wearing the actigraphy watches during the baseline and intervention weeks. It also involves participating in daily guided meditation during the day time and listening to relaxation audio before sleep during the intervention week
What are the possible benefits and risks of participating?
The benefits include possible improvement of sleep quality and other parameters of sleep. There may be unwanted emotions, thoughts and feelings surfacing up during meditation that may provoke anxiety or stress. If such experiences occur, participants may stop at any time and may only do what they are comfortable with.
Where is the study run from?
Wellspan Apple Hill internal medicine outpatient office (USA)
When is the study starting and how long is it expected to run for?
February 2017 to October 2020
Who is funding the study?
1. Alliance for Academic Internal Medicine (AAIM) (USA)
2. Lake Eerie College of Osteopathic Medicine (LECOM) (USA)
Who is the main contact?
Dr Jayaram Thimmapuram
jthimmapuram@wellspan.org
Contact information
Scientific
2780, Meadow Cross Way
York
17402
United States of America
 ORCID ID |
0000-0002-3189-3863 |
|---|---|
| Phone | +1 (0)717 851 2345 |
| jthimmapuram@wellspan.org |
Study information
| Study design | Single-center non-randomized prospective pre-post cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Scientific title | Sleep patterns in internal medicine resident physicians and the effect of heartfulness meditation during outpatient rotation |
| Study objectives | Participation in daily Heartfulness meditation improves sleep parameters in resident physicians during outpatient rotation. |
| Ethics approval(s) | Approved 23/05/2017, WellSpan Institutional Review Board (1001, S George St., Wellspan Health, York, Pennsylvania, 17402, USA; +1 (0)717 851 2223; irb@wellspan.org), ref: not applicable |
| Health condition(s) or problem(s) studied | Sleep quality in resident physicians |
| Intervention | A consensus sleep diary (CSD) is completed, and sleep is monitored using actigraphy during a 1-week outpatient rotation. After four intervening weeks, when the residents returned to the same rotation, Heartfulness meditation is practiced and the same parameters are measured. All the participating residents in the study are given instructions on Heartfulness meditation, and daily guided relaxation and meditation sessions are conducted in the office for 20 minutes. In addition, participants are asked to listen to a Heartfulness relaxation audio prior to sleep. |
| Intervention type | Behavioural |
| Primary outcome measure | Sleep quality measured using Consensus Sleep Diary (CSD) and actigraphy watches measured during baseline outpatient rotation week and repeated during the intervention week with Heartfulness meditation |
| Secondary outcome measures | 1. Subjective sleep quality measured using CSD during baseline outpatient rotation week and repeated during the intervention week with Heartfulness meditation 2. Objective sleep parameters measured using actigraphy watches during baseline outpatient rotation week and repeated during the intervention week with Heartfulness meditation |
| Overall study start date | 02/02/2017 |
| Completion date | 01/10/2020 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 36 |
| Total final enrolment | 36 |
| Key inclusion criteria | All resident physicians willing to participate in the study |
| Key exclusion criteria | 1. Residents unwilling to participate in the study 2. This study is not designed for people who are experiencing psychological distress that may be associated with bipolar disorder, substance abuse (drugs or alcohol abuse in last 6 months), alcohol withdrawal, BMI <18 kg/m², suicidal ideation, active psychotherapy, major depression, anxiety disorder, obstructive sleep apnea requiring CPAP, eating disorder, borderline personality disorder, posttraumatic stress disorder, or psychotic disorder |
| Date of first enrolment | 06/01/2019 |
| Date of final enrolment | 03/02/2019 |
Locations
Countries of recruitment
- United States of America
Study participating centre
York
17402
United States of America
Sponsor information
Hospital/treatment centre
1001 S George St
York
17403
United States of America
| Phone | +1 (0)717 851 2223 |
|---|---|
| irb@wellspan.org | |
"ROR" |
https://ror.org/01nknep14 |
Funders
Funder type
University/education
No information available
No information available
Results and Publications
| Intention to publish date | 01/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | 1. The study protocol has not been published online. Most elements of the protocol have been included in this registration. 2. Planned publication of the study results in a high-impact peer-reviewed journal. |
| IPD sharing plan | Participant data is stored with the research department at Wellspan Health. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 23/09/2021 | 09/06/2022 | Yes | No |
Editorial Notes
09/06/2022: Publication reference added.
04/03/2021: Trial's existence confirmed by WellSpan Institutional Review Board.
