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临床试验/NCT03687450
NCT03687450已完成不适用

Feasibility of a Yoga- and Mindfulness-Based Intervention for Resident Physicians

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
2
主要终点
Feasibility of Attending the Yoga Program

研究概览

简要总结

The investigators aim to initiate and complete the first investigation of the effect of a yoga-based program on resident physicians' psychological health using a randomized controlled trial to assess feasibility of the program in this population and measure outcomes across several domains. To meet the goals of the proposed project the investigators have identified 3 specific aims:

Specific Aim 1: Assess the acceptability and feasibility of the yoga program through measuring participation and conducting standardized interviews with a subset of yoga participants.

Specific Aim 2: Evaluate the effect of the yoga program on resident physicians' stress, burnout, resilience, mindfulness, mood, depression, anxiety, and sleep quality using quantitative self-report measures.

Specific Aim 3. Examine whether outcome measures were perceived as relevant to the participants' work environment and were not burdensome as to the length and content of the program.

详细描述

The project will implement a single group mixed-methods randomized controlled trial to investigate the impact of the 6-week RISE program on psychological health in Longwood medical area residents. The RISE program is an existing standardized yoga program at Kripalu that will be adapted for residents in a 60-90-minute, once-weekly class for six weeks. Participants will be randomized to either the RISE yoga program or a no-treatment control group. Participants randomized to the RISE program will also be instructed to maintain a short 10-15-minute daily home yoga practice. Sessions will be lead by experienced instructors from Kripalu and will be held in the Longwood medical area. Self-report outcomes will be assessed at baseline, at program completion (post-program), at 2-month follow-up, and at 6-month follow-up.

Participants will include resident physicians at Longwood medical area hospitals. The only exclusion criterion is having practiced yoga, meditation, tai chi, qigong, or another mind-body practice at least 25 hours or more in the past 6 months. Participants must be willing not to practice mind-body programs other than the treatment protocol during the intervention. We plan to enroll up to 200 participants with a goal of at least 60 participants with a 2:1 ratio of participants randomized to yoga to participants randomized to control. The control group will receive one session of RISE after their participation in the trial is complete.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Individuals enrolled in residency programs at Brigham and Women's Hospital, Beth Israel Deaconess, Boston Children's Hospital, or a Harvard Combined Residency Program
  • Individuals must be willing to not practice mind-body programs other than the intervention during the treatment protocol
  • Must be proficient in English

排除标准

  • Individuals who currently practice yoga, meditation, tai chi, qigong, and other mind-body practices more than 25 hours in the past 6 months

结局指标

主要结局

Feasibility of Attending the Yoga Program

时间窗: Post-program

Participants were ask to rate the feasibility of attending the yoga program on a visual analogue scale from 0 (not at all feasible) to 100 (very feasible). Only the intervention group rated feasibility since the control group was a waitlist control group and did not attend the program. The standard deviation of the mean score was calculated.

次要结局

  • Difference in Burnout(Post-program and 2-month follow-up)
  • Difference in Resident Well-being(Baseline, post-program, and 2-month follow-up)
  • Difference in Professional Fulfillment(Baseline, post-program, and 2-month follow-up)
  • Difference in Resilience(Baseline, post-program, and 2-month follow-up)
  • Difference in Mindfulness(Baseline, post-program, and 2-month follow-up)
  • Difference in Stress(Baseline, post-program, and 2-month follow-up)
  • Differences in Professional Fulfillment - Burnout Sub-Item(Baseline, post-program, and 2-month follow-up)
  • Difference in Depression(Baseline, post-program, and 2-month follow-up)
  • Difference in Sleep Quality(Baseline, post-program, and 2-month follow-up)
  • Difference in Anxiety(Baseline, post-program, and 2-month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sat Bir Khalsa, PhD

Assistant Professor of Medicine

Brigham and Women's Hospital

研究点 (2)

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