A Comprehensive Wellness Program (SKY) to Mitigate Physician Burnout

NCT ID: NCT05956470

Last Updated: 2023-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-11

Study Completion Date

2022-03-20

Brief Summary

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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

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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.

Conditions

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Depression Anxiety Stress Insomnia Optimism Interpersonal Disengagement Professional Fulfillment Work Exhaustion Self-reported Medical Errors Physician Burnout

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
The people analysing the results/data were masked.

Study Groups

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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.

Group Type EXPERIMENTAL

Meditation and breathing program : Sudarshan Kriya Yoga (SKY)

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Stress management education

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Akershus

OTHER

Sponsor Role collaborator

Koc University Hospital, Istanbul, Turkey

UNKNOWN

Sponsor Role collaborator

Ataturk Chest Diseases Education and Research Hospital, Ankara, Turkey

UNKNOWN

Sponsor Role collaborator

Izmir Biomedicine and Genome Center

OTHER_GOV

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Fahri Saatcioglu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Izmir Biomedicine and Genome Center

Izmir, Balcova, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 36162039 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33555934 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7726811 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7815302 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29196982 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23601161 (View on PubMed)

Korkmaz A, Bernhardsen GP, Cirit B, Koprucu Suzer G, Kayan H, Bicmen H, Tahra M, Suner A, Lehto SM, Sag D, Saatcioglu F. Sudarshan Kriya Yoga Breathing and a Meditation Program for Burnout Among Physicians: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2353978. doi: 10.1001/jamanetworkopen.2023.53978.

Reference Type DERIVED
PMID: 38294813 (View on PubMed)

Other Identifiers

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iBG-2021-015

Identifier Type: -

Identifier Source: org_study_id

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