Clinical trial NCT05956470: A Comprehensive Wellness Program (SKY) to Mitigate Physician Burnout
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Stress
Insomnia
Optimism
Interpersonal Disengagement
Professional Fulfillment
Work Exhaustion
Self-reported Medical Errors
Physician Burnout
Keywords: physician burnout
medical doctor
burnout
stress
depression
wellness
meditation
breathing exercise
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Akershus
name: Koc University Hospital, Istanbul, Turkey
name: Ataturk Chest Diseases Education and Research Hospital, Ankara, Turkey
name: Izmir Biomedicine and Genome Center
First posted: 2023-07-21
Enrollment: 128
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline Depression, Anxiety, and Stress scale immediately after the intervention and at 8 weeks
timeFrame: At baseline, right after the 3-day intervention, and at 8 weeks post-intervention
measure: Change from baseline in Professional Satisfaction index post-intervention and at 8 weeks
timeFrame: At baseline, right after the 3-day intervention, and at 8 weeks post-intervention
measure: Change from baseline in optimism post-intervention and at 8 weeks
timeFrame: At baseline, right after the 3-day intervention, and at 8 weeks post-intervention
measure: Change from baseline in Insomnia post-intervention and at 8 weeks
timeFrame: At baseline, right after the 3-day intervention, and at 8 weeks post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir Biomedicine and Genome Center
state: Balcova
Study officials:
References:
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