A Protocol for a Phase-II Trial to Evaluate the Effect of a Mindfulness Intervention via a Mobile Application on Resident Physicians’ Burnout

Dalia Ahmed, M. V. Osten, Marco A. Grudtner, E. Mazzon, Jesús Serrato, Ximena Milagros Garcìa Felipa, S. Lemouche, H. Abushama, Natacha De Jesus Vargas Disla, Mohamed Fathy Mohamed Abdelgelil, S. Gorantla, C. Villarreal-Garza
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Abstract

Background:  Burnout is a highly prevalent occupation-related syndrome that impacts both physicians and patients. Resident physicians face unique challenges and stressors during their training, causing burnout, which affects the quality of care, patient outcomes, and the physician well being. In addition, mitigation of physician burnout creates a resilient future physician workforce. Mobile-based mindfulness interventions showed promising results in reducing physicians’ burnout. This paper describes the rationale and design of the first global multi-centered prospective randomized control study to assess the impact of mobile-based mindfulness on resident physician burnout. Methods: We plan to conduct a multicenter cluster-randomized two-arms (1:1 ratio), double-blinded clinical trial. Institutions will be randomly assigned to the use of the Smiling Mind app or a dummy app. Participants will be reassessed at 30 and 60 days for the 3 aspects of the Maslach Burnout Inventory Scale (MBIS). The primary outcome for analysis is the emotional exhaustion aspect of the MBIS at 30 days. A linear mixed regression model with adjustments for clusters will be used. Discussion: Burnout is a major issue especially among the particularly vulnerable and time-constrained group of physicians-in-training. Mindfulness-Based Stress Reduction programs are time-consuming. This study will offer the opportunity to investigate the effect of a brief mobile-based mindfulness intervention on resident physicians burnout.
通过移动应用程序评估正念干预对住院医师职业倦怠影响的ii期试验方案
背景:职业倦怠是一种非常普遍的职业相关综合症,对医生和患者都有影响。住院医师在培训过程中面临着独特的挑战和压力源,导致倦怠,影响护理质量,患者预后和医生的健康。此外,医生职业倦怠的缓解创造了一个有弹性的未来医生队伍。基于手机的正念干预在减少医生的职业倦怠方面显示出良好的效果。本文描述了第一项全球多中心前瞻性随机对照研究的基本原理和设计,以评估基于移动的正念对住院医师职业倦怠的影响。方法:我们计划进行一项多中心集群随机两组(1:1比例)双盲临床试验。机构将被随机分配使用“微笑心灵”应用程序或虚拟应用程序。参与者将在第30天和第60天就马斯拉克职业倦怠量表(MBIS)的三个方面进行重新评估。分析的主要结果是MBIS在30天的情绪衰竭方面。将使用线性混合回归模型对聚类进行调整。讨论:倦怠是一个主要问题,特别是在特别脆弱和时间有限的培训医师群体中。以正念为基础的减压计划非常耗时。本研究将提供一个机会来调查一个简短的基于移动的正念干预对住院医师职业倦怠的影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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