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Completed

NCT Number: NCT05956470

A Comprehensive Wellness Program (SKY) to Mitigate Physician Burnout

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.

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Burnout, Psychological Dyssomnias Insomnia Interpersonal Disengagement Mental Disorders Nervous System Diseases Optimism Physician Burnout Professional Fulfillment Self-reported Medical Errors Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Stress Stress, Psychological Work Exhaustion

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Izmir Biomedicine and Genome Center

Izmir, Balcova, 35330, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Meditation and breathing program : Sudarshan Kriya Yoga (SKY)

Behavioral

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.

Stress Management Education

Behavioral

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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

  4. 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).

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Ataturk Chest Diseases Education and Research Hospital, Ankara, Turkey
  • Izmir Biomedicine and Genome Center
  • Koc University Hospital
  • University Hospital, Akershus

Registry information

Official study 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

Acronym: SKY

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 21, 2023
Registry last updated
Jul 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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