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A Comprehensive Wellness Program (SKY) to Mitigate Physician Burnout (SKY)

Primary Purpose

Depression, Anxiety, Stress

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Meditation and breathing program : Sudarshan Kriya Yoga (SKY)
Stress management education
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression focused on measuring physician burnout, medical doctor, burnout, stress, depression, wellness, meditation, breathing exercise

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Izmir Biomedicine and Genome Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SKY intervention group

Control group

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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).
Change from baseline in Professional Satisfaction index post-intervention and at 8 weeks
Scores assessed by the Professional Satisfaction Index (PFI).
Change from baseline in optimism post-intervention and at 8 weeks
Optimism scores assessed by the Life Orientation Test (Revised) (LOT-R) and the
Change from baseline in Insomnia post-intervention and at 8 weeks
Insomnia scores assesed by the Regensburg Insomnia Scale (RIS).

Secondary Outcome Measures

Full Information

First Posted
July 6, 2023
Last Updated
July 13, 2023
Sponsor
Oslo University Hospital
Collaborators
Akershus University Hospital, Lørenskog, Norway, Koc University Hospital, Istanbul, Turkey, Ataturk Chest Diseases Education and Research Hospital, Ankara, Turkey, Izmır Biomedicine and Genome Center, Izmir, Turkey
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1. Study Identification

Unique Protocol Identification Number
NCT05956470
Brief Title
A Comprehensive Wellness Program (SKY) to Mitigate Physician Burnout
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 11, 2021 (Actual)
Primary Completion Date
January 17, 2022 (Actual)
Study Completion Date
March 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Akershus University Hospital, Lørenskog, Norway, Koc University Hospital, Istanbul, Turkey, Ataturk Chest Diseases Education and Research Hospital, Ankara, Turkey, Izmır Biomedicine and Genome Center, Izmir, Turkey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The people analysing the results/data were masked.
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SKY intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Meditation and breathing program : Sudarshan Kriya Yoga (SKY)
Intervention Description
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
Intervention Name(s)
Stress management education
Intervention Description
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 Outcome Measure Information:
Title
Change from Baseline Depression, Anxiety, and Stress scale immediately after the intervention and at 8 weeks
Description
Scores assessed by the Depression, Anxiety, and Stress Scale 42 (DASS-42).
Time Frame
At baseline, right after the 3-day intervention, and at 8 weeks post-intervention
Title
Change from baseline in Professional Satisfaction index post-intervention and at 8 weeks
Description
Scores assessed by the Professional Satisfaction Index (PFI).
Time Frame
At baseline, right after the 3-day intervention, and at 8 weeks post-intervention
Title
Change from baseline in optimism post-intervention and at 8 weeks
Description
Optimism scores assessed by the Life Orientation Test (Revised) (LOT-R) and the
Time Frame
At baseline, right after the 3-day intervention, and at 8 weeks post-intervention
Title
Change from baseline in Insomnia post-intervention and at 8 weeks
Description
Insomnia scores assesed by the Regensburg Insomnia Scale (RIS).
Time Frame
At baseline, right after the 3-day intervention, and at 8 weeks post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Izmir Biomedicine and Genome Center
City
Izmir
State/Province
Balcova
ZIP/Postal Code
35330
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36162039
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.
Results Reference
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PubMed Identifier
33555934
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.
Results Reference
background
PubMed Identifier
7726811
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.
Results Reference
background
PubMed Identifier
7815302
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.
Results Reference
background
PubMed Identifier
29196982
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.
Results Reference
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PubMed Identifier
23601161
Citation
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.
Results Reference
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A Comprehensive Wellness Program (SKY) to Mitigate Physician Burnout

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