A Comprehensive Wellness Program (SKY) to Mitigate Physician Burnout

Sponsor

Oslo University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05956470

Collaborator

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

128

Enrollment

Location

Arms

4.2

Actual Duration (Months)

30.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Depression Anxiety Stress Insomnia Optimism Interpersonal Disengagement Professional Fulfillment Work Exhaustion Self-reported Medical Errors Physician Burnout	Behavioral: Meditation and breathing program : Sudarshan Kriya Yoga (SKY) Behavioral: Stress management education	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

128 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

The people analysing the results/data were masked.

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Nov 11, 2021

Actual Primary Completion Date :

Jan 17, 2022

Actual Study Completion Date :

Mar 20, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change from Baseline Depression, Anxiety, and Stress scale immediately after the intervention and at 8 weeks [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).
Change from baseline in Professional Satisfaction index post-intervention and at 8 weeks [At baseline, right after the 3-day intervention, and at 8 weeks post-intervention]
Scores assessed by the Professional Satisfaction Index (PFI).
Change from baseline in optimism post-intervention and at 8 weeks [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
Change from baseline in Insomnia post-intervention and at 8 weeks [At baseline, right after the 3-day intervention, and at 8 weeks post-intervention]
Insomnia scores assesed by the Regensburg Insomnia Scale (RIS).

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.