A Comprehensive Wellness Program (SKY) to Mitigate Physician Burnout

Depression Clinical Trial

— SKY  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05956470
• Other study ID #: iBG-2021-015
• Status: Completed
• Phase: N/A
• Start date: November 11, 2021
• Est. completion date: March 20, 2022

Study information

• Verified date: July 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: March 20, 2022
• Est. primary completion date: January 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Burnout, Psychological
• Depression
• Insomnia
• Optimism
• Stress

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Izmir Biomedicine and Genome Center	Izmir	Balcova

Sponsors (5)

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

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Cronlein T, Langguth B, Popp R, Lukesch H, Pieh C, Hajak G, Geisler P. Regensburg Insomnia Scale (RIS): a new short rating scale for the assessment of psychological symptoms and sleep in insomnia; study design: development and validation of a new short self-rating scale in a sample of 218 patients suffering from insomnia and 94 healthy controls. Health Qual Life Outcomes. 2013 Apr 22;11:65. doi: 10.1186/1477-7525-11-65. — View Citation

Hlubocky FJ, Symington BE, McFarland DC, Gallagher CM, Dragnev KH, Burke JM, Lee RT, El-Jawahri A, Popp B, Rosenberg AR, Thompson MA, Dizon DS, Srivastava P, Patel MI, Kamal AH, Daugherty CK, Back AL, Dokucu ME, Shanafelt TD. Impact of the COVID-19 Pandemic on Oncologist Burnout, Emotional Well-Being, and Moral Distress: Considerations for the Cancer Organization's Response for Readiness, Mitigation, and Resilience. JCO Oncol Pract. 2021 Jul;17(7):365-374. doi: 10.1200/OP.20.00937. Epub 2021 Feb 8. No abstract available. — View Citation

Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u. — View Citation

Saatcioglu F, Cirit B, Koprucu Suzer G. The Promise of Well-Being Interventions to Mitigate Physician Burnout During the COVID-19 Pandemic and Beyond. JCO Oncol Pract. 2022 Dec;18(12):808-814. doi: 10.1200/OP.22.00108. Epub 2022 Sep 26. — View Citation

Scheier MF, Carver CS, Bridges MW. Distinguishing optimism from neuroticism (and trait anxiety, self-mastery, and self-esteem): a reevaluation of the Life Orientation Test. J Pers Soc Psychol. 1994 Dec;67(6):1063-78. doi: 10.1037//0022-3514.67.6.1063. — View Citation

Trockel M, Bohman B, Lesure E, Hamidi MS, Welle D, Roberts L, Shanafelt T. A Brief Instrument to Assess Both Burnout and Professional Fulfillment in Physicians: Reliability and Validity, Including Correlation with Self-Reported Medical Errors, in a Sample of Resident and Practicing Physicians. Acad Psychiatry. 2018 Feb;42(1):11-24. doi: 10.1007/s40596-017-0849-3. Epub 2017 Dec 1. — View Citation

Outcome

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