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临床试验/NCT05956470
NCT05956470已完成不适用

A Comprehensive Meditation and Breath Program (SKY) as an Adjunct Tool to Increase Resilience and Wellness in Frontline Healthcare Workers - A Randomized Pilot Study

Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2021年11月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
128
试验地点
2
主要终点
Change from Baseline Depression, Anxiety, and Stress scale immediately after the intervention and at 8 weeks

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

The people analysing the results/data were masked.

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Change from Baseline Depression, Anxiety, and Stress scale immediately after the intervention and at 8 weeks

时间窗: 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).

Change from baseline in Professional Satisfaction index post-intervention and at 8 weeks

时间窗: At baseline, right after the 3-day intervention, and at 8 weeks post-intervention

Scores assessed by the Professional Satisfaction Index (PFI).

Change from baseline in Insomnia post-intervention and at 8 weeks

时间窗: At baseline, right after the 3-day intervention, and at 8 weeks post-intervention

Insomnia scores assesed by the Regensburg Insomnia Scale (RIS).

Change from baseline in optimism post-intervention and at 8 weeks

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fahri Saatcioglu

Professor

Oslo University Hospital

研究点 (2)

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