Mindfulness- based stress reduction or aerobics exercise for reducing burnout in medical residents- a study protocol for a phase III, open-label, multi-center, randomized controlled trial The MINDER Collaborative group study

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Ahmed Mubark Omer Elamin
Bruno Fu Lon Chen
Carlos Davila Peixoto, DDS., MPH., DHSc
Eduardo Barrera-Juarez, MD
Eltahir Mohammed Alhassan
Fathima Minisha, MRCOG
Francisco Eronildo Franco Rodrigues, MD
Hamzeh Khmour
Joao Paulo Cassiano de Macedo
Joao Vitor Miranda Porto de Oliveira
Katalina Bertran, MD
Katherine Judith Victorio Subervi
Luiz Antonio Brito Arruda Vasconcelos, MD
Lorena Ostios-Garcia
Mahmoud Ahmed Ahmed Refaee
Maria de Lourdes Teran
Michelle Andrea Garlin-Politis, MD
Miosotis Josefina Valenzuela Jiminian, MD
Sandra Regina Bonfim Rodrigues
Saveria Sangiovanni, MD
Syed Muhammad Dildar Hussain
Thais Grigoleto Pimentel
Vivianne Aguilera Freitas, MD
Xavier De Pena-Pena
Zohaib Yousaf, MD
Chantal Doucet, DC, MSc
Alejandro Gonzalez-Motta, MD
Danial Hassan
Asli Ercan Dogan, MD
Paula Rojas, MD
Augusto Cesar Soares dos Santos Junior, MD, PhD

Abstract

Background and objectives:


Burnout results from chronic workplace stress leading to emotional exhaustion, negativity, and decreased professional efficiency. In the healthcare system, this can have consequences like increased medical errors, absenteeism, substance abuse, depression, and suicide among health professionals, adversely affecting patient care. Various individual-directed measures like the mindfulness-based stress reduction program (MBSR), one of the most studied and widely adopted techniques, and physical activity, like aerobics or sports, have shown to be effective against burnout. With this study, we intend to increase awareness regarding this public health issue among the residents and the faculty. Our aim is to define a successful intervention that can be incorporated as a yearly requirement for the completion of residency programs.


Methodology:


This study will be a phase III, multicentric, open-label, placebo (waiting list) controlled trial. Our sample size will be 720 residents sampled from 6 university hospitals from across the world, randomized into 3 parallel arms (1:1:1 ratio stratified according to site and specialty). Residents, diagnosed with burnout based on baseline Maslach Burnout Inventory score (MBI) and having no prior physical or mental health issues, will be included. The first group will undergo the MBSR program for 8 weeks, the second group will undergo a supervised aerobics program for 8 weeks, and the third group will be put into a waiting list for any of the interventions. The primary outcome will be the change in MBI scores after the intervention. The secondary outcomes will be the change in MBI score 3 months after the intervention, and changes in measures like heart rate, blood pressure, glycated hemoglobin, cortisol levels, quality of sleep and quality of life after the intervention and 3 months later. We also plan to do a subgroup analysis to see the difference based on specialty and gender.


Study impact:


The residency training period is considered one of the most stressful phases in medical education. Higher rates of burnout are noted in the residents, and this can negatively impact patient care and the progression of their careers. This trial will look at multiple interventions to combat burnout recruiting residents of different specialties in different work environments across the world. We hope to remove the stigma surrounding burnout in the healthcare system. This study will show the short and long term benefits of these interventions and would help us recommend their inclusion in various residency programs.

Article Details

How to Cite
Elamin, A. M. O., Chen, B. F. L., Peixoto, C. D., Barrera-Juarez, E., Alhassan, E. M., Minisha, F., Rodrigues, F. E. F., Khmour, H., Macedo, J. P. C. de, de Oliveira, J. V. M. P., Bertran, K., Subervi, K. J. V., Vasconcelos, L. A. B. A., Ostios-Garcia, L., Refaee, M. A. A., Teran, M. de L., Garlin-Politis, M. A., Jiminian, M. J. V., Abd El Hamid, M., Rodrigues, S. R. B., Sangiovanni, S., Hussain, S. M. D., Pimentel, T. G., Freitas, V. A., De Pena-Pena, X., Yousaf, Z., Doucet, C., Gonzalez-Motta, A., Hassan, D., Dogan, A. E., Rojas, P., & Soares dos Santos Junior, A. C. (2020). Mindfulness- based stress reduction or aerobics exercise for reducing burnout in medical residents- a study protocol for a phase III, open-label, multi-center, randomized controlled trial: The MINDER Collaborative group study. Principles and Practice of Clinical Research, 6(2), 13-20. https://doi.org/10.21801/ppcrj.2020.62.3
Section
Study Design
Author Biographies

Eduardo Barrera-Juarez, MD, Tecnologico de Monterrey

Program Director, Post Graduate

Department of Urology, 

School of Medicine and Health Sciences, 

Tecnologico de Monterry,

Batallon de San Patricio 112

Col. Real San Agustin

San Pedro Garza Garcia, N.L

Contact: 88880575

Joao Paulo Cassiano de Macedo, University of Sao Paulo

Thoracic Surgeon

Katalina Bertran, MD, Clinica Alemana de Santiago

Pediatric Pneumologist, 

Sleep Unit,

Department of Pediatrics

Paula Rojas, MD, Clinica Alemana, Santiago Chile

Pediatric Emergency Medicine    

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