A Comprehensive Wellness Program (SKY) to Mitigate Physician Burnout (SKY)

July 13, 2023 updated by: Fahri Saatcioglu, Oslo University Hospital

A Comprehensive Meditation and Breath Program (SKY) as an Adjunct Tool to Increase Resilience and Wellness in Frontline Healthcare Workers - A Randomized Pilot Study

The primary objective of the study was to determine whether the yoga-based breathing and meditation program SKY could improve wellness indicators in currently practicing physicians. The hypothesis of this study is that SKY is effective in reducing anxiety and depression, increasing subjective optimism, and reducing physician burnout in healthy, actively practicing physicians.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Physicians are exposed to high stress and strain that results in burnout, affecting not only them, their families, patients, but the whole healthcare system. Thus there is an urgent need to develop methods to increase resiliency of physicians. A comprehensive yoga breathing and meditation-based online program (Sudarshan Kriya Yoga, or SKY) is a potential approach to mitigate physician burnout. This is a randomized clinical trial assessing the potential efficacy of SKY compared to a stress management education (SME) training as control, conducted online. Both groups received training for three consecutive days, 1,5 hours per day, through group video conference. Active physicians participated in the study from November 2021 to March 2022. Of the 280 physicians who showed interest and prescreened, 238 were eligible and randomized to receive either the SKY or the control intervention.

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Balcova
      • Izmir, Balcova, Turkey, 35330
        • Izmir Biomedicine and Genome Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Actively working physicians without any chronic disease with documented interest in being part of a study to evaluate breath/meditation-derived exercises and a willingness to do some form of relaxation exercises every day for 8 weeks.

Exclusion Criteria:

  • Presence of psychiatric illness or other major illnesses, such as bipolar disorder, post-traumatic stress disorder (PTSD), schizophrenia or schizoaffective disorder, uncontrolled hypertension, lung disease, liver disease, cancer, or heart disease; maintaining a regular mind-body program practice such as meditation, yoga, and breathing techniques.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SKY intervention group
Meditation and breath program: includes gentle stretches (office yoga' in a sitting position) and three different types of specific breathing exercises. 3x1,5 hours. Daily practice thereafter for about 30 minutes for 8 weeks. In addition, there are weekly one-hour sessions for group practice and discussion.
Behavioral: Meditation and breathing program : Sudarshan Kriya Yoga (SKY)
The SKY sessions (3x1,5 h on consecutive days) included online instruction in gentle stretches ('office yoga' in a sitting position), specific breathing exercises and meditation, and discussion of cognitive/behavioral coping skills. After the 3-day program, participants asked to practice the techniques once a day for about 30 min. In addition, there were weekly group exercise sessions of 1 hour where all participants were asked to join.
Active Comparator: Control group
Group discussion-based viewing of online educational videos that demonstrate ways to mitigate psychological distress, including the use of cognitive coping techniques. 3x1,5 hours. It includes weekly online meetings with group discussions, experience sharing, and watching brief videos on the key elements of the program for 8 weeks.
Behavioral: Stress management education
This control intervention included viewing of educational videos on stress management and group discussions, where the sessions were equal in length to the SKY intervention. There were also weekly follow-up sessions as in the SKY group where the educational points were reviewed and experiences of the subjects during the previous week was discussed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Depression, Anxiety, and Stress scale immediately after the intervention and at 8 weeks
Time Frame: At baseline, right after the 3-day intervention, and at 8 weeks post-intervention
Scores assessed by the Depression, Anxiety, and Stress Scale 42 (DASS-42).
At baseline, right after the 3-day intervention, and at 8 weeks post-intervention
Change from baseline in Professional Satisfaction index post-intervention and at 8 weeks
Time Frame: At baseline, right after the 3-day intervention, and at 8 weeks post-intervention
Scores assessed by the Professional Satisfaction Index (PFI).
At baseline, right after the 3-day intervention, and at 8 weeks post-intervention
Change from baseline in optimism post-intervention and at 8 weeks
Time Frame: At baseline, right after the 3-day intervention, and at 8 weeks post-intervention
Optimism scores assessed by the Life Orientation Test (Revised) (LOT-R) and the
At baseline, right after the 3-day intervention, and at 8 weeks post-intervention
Change from baseline in Insomnia post-intervention and at 8 weeks
Time Frame: At baseline, right after the 3-day intervention, and at 8 weeks post-intervention
Insomnia scores assesed by the Regensburg Insomnia Scale (RIS).
At baseline, right after the 3-day intervention, and at 8 weeks post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Akershus University Hospital, Lørenskog, Norway
Koc University Hospital, Istanbul, Turkey
Ataturk Chest Diseases Education and Research Hospital, Ankara, Turkey
Izmır Biomedicine and Genome Center, Izmir, Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2021

Primary Completion (Actual)

January 17, 2022

Study Completion (Actual)

March 20, 2022

Study Registration Dates

First Submitted

July 6, 2023

First Submitted That Met QC Criteria

July 13, 2023

First Posted (Actual)

July 21, 2023

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iBG-2021-015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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