Ettenberger Mark, Maya Rafael, Salgado-Vasco Andrés, Monsalve-Duarte Sofia, Betancourt-Zapata William, Suarez-Cañon Nicolas, Prieto-Garces Sergio, Marín-Sánchez Juliana, Gómez-Ortega Viviana, Valderrama Mario
Department of Music Therapy, University Hospital Fundación Santa Fe de Bogotá, Bogotá, Colombia.
Department of Biomedical Engineering, University Los Andes, Bogotá, Colombia.
Front Psychiatry. 2021 Oct 18;12:714209. doi: 10.3389/fpsyt.2021.714209. eCollection 2021.
Burn patients experience major physiological and psychological stressors during treatment and rehabilitation, including elevated levels of pain, anxiety, stress, or depression. Music interventions inclusive of music therapy (MT) have been shown to improve such symptoms, but rigorous clinical trials investigating specific music therapy methods in adult burn patients are scarce. This is a single center Randomized Controlled Trial (RCT) protocol with two parallel arms. Participants are 81 adult burn patients admitted to the Intensive Care Unit (ICU) of the University Hospital Fundación Santa Fe de Bogotá in Colombia. The intervention consists of a Music Assisted Relaxation (MAR) protocol, a music therapy technique composed of entrained live music combined with a guided relaxation and/or the use of imagery. The effects of the MAR will be compared to a control group (treatment as usual) over a period of maximum 2 weeks or six interventions. The primary outcome measure is perceived background pain, as measured with a Visual Analog Scale (VAS) before and after each intervention. Secondary outcomes are anxiety and depression levels; vital signs; and the use of pain medication. Additionally, some patients in the intervention group will be invited to participate in electroencephalography, electromyography, and electrocardiography recordings during the MAR. This study protocol follows the SPIRIT guidelines for defining items of clinical trials and is the first study in Colombia to evaluate the effects of music therapy for adult burn patients. With this RCT it is hoped to gather new knowledge about the potential of music therapy to help critical care patients cope and recover from their injuries during the hospitalization in the ICU. www.clinicaltrials.gov, Identifier: NCT04571255. V1.0, May 24th 2021.
烧伤患者在治疗和康复过程中会经历重大的生理和心理应激源，包括疼痛、焦虑、压力或抑郁水平升高。包括音乐疗法（MT）在内的音乐干预已被证明可以改善这些症状，但针对成年烧伤患者特定音乐疗法的严格临床试验却很少。这是一项单中心随机对照试验（RCT）方案，有两个平行组。参与者为81名成年烧伤患者，他们被收治到哥伦比亚波哥大圣菲德波哥大基金会大学医院的重症监护病房（ICU）。干预措施包括音乐辅助放松（MAR）方案，这是一种音乐疗法技术，由同步的现场音乐与引导放松和/或意象运用相结合组成。将在最长2周或六次干预的时间段内，将MAR的效果与对照组（常规治疗）进行比较。主要结局指标是每次干预前后用视觉模拟量表（VAS）测量的感知背景疼痛。次要结局指标是焦虑和抑郁水平、生命体征以及止痛药物的使用情况。此外，干预组的一些患者将被邀请在MAR期间参与脑电图、肌电图和心电图记录。本研究方案遵循SPIRIT指南来定义临床试验项目，是哥伦比亚第一项评估音乐疗法对成年烧伤患者效果的研究。通过这项随机对照试验，希望能收集到关于音乐疗法在帮助重症监护患者在ICU住院期间应对伤痛并康复方面潜力的新知识。www.clinicaltrials.gov，标识符：NCT04571255。V1.0，2021年5月24日。
