A Comprehensive Wellness Program (SKY) to Mitigate Physician Burnout

NCT05956470 | Completed

• 1 other identifier: iBG-2021-015
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

SKY intervention group

EXPERIMENTAL

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)

Control group

ACTIVE COMPARATOR

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

Interventions

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.

SKY intervention group

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.

Control group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead
• University Hospital, Akershus: collaborator
• Koc University Hospital, Istanbul, Turkey: collaborator
• Ataturk Chest Diseases Education and Research Hospital, Ankara, Turkey: collaborator
• Izmir Biomedicine and Genome Center: collaborator

Study Sites (1)

Izmir Biomedicine and Genome Center

Izmir, Balcova, 35330, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 36162039 BACKGROUND

• 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.

  PMID: 33555934 BACKGROUND

• 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.

  PMID: 7726811 BACKGROUND

• 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.

  PMID: 7815302 BACKGROUND

• 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.

  PMID: 29196982 BACKGROUND

• 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.

  PMID: 23601161 BACKGROUND

• 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.

  PMID: 38294813 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Sleep Initiation and Maintenance Disorders; Burnout, Psychological

Interventions

Meditation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Stress, Psychological

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The people analysing the results/data were masked.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 21, 2023
• Study Start: November 11, 2021
• Primary Completion: January 17, 2022
• Study Completion: March 20, 2022
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

TU (1)