用于危重症儿童镇静的音乐疗法（MUSiCC试验）：一项初步随机对照试验的研究方案
Music Use for Sedation in Critically ill Children (MUSiCC trial): study protocol for a pilot randomized controlled trial.
作者信息
Garcia Guerra Gonzalo, Joffe Ari, Sheppard Cathy, Hewson Krista, Dinu Irina A, de Caen Allan, Jou Hsing, Hartling Lisa, Vohra Sunita
机构信息
1Department of Pediatrics, University of Alberta, College Plaza 8215 112 St NW, Edmonton, AB T6G 1C9 Canada.
2Stollery Children's Hospital, Edmonton, AB Canada.
出版信息
Pilot Feasibility Stud. 2020 Feb 25;6:31. doi: 10.1186/s40814-020-0563-x. eCollection 2020.
BACKGROUND
Stress induced by pain and anxiety is common in pediatric intensive care unit (PICU) patients. Sedation/analgesia in PICU is usually achieved through various analgesics and sedatives. Excessive use of these drugs can put patients at risk for hemodynamic/respiratory instability, prolonged ventilation, withdrawal, delirium, and critical illness polyneuromyopathy.The use of non-pharmacologic interventions has been recommended by sedation guidelines. However, non-pharmacological measures in PICU, including music and noise reduction, have been inadequately studied.
METHODS
The Music Use for Sedation in Critically ill Children (MUSiCC trial) pilot study is an investigator-initiated, three-arm, randomized controlled trial (RCT) on the use of music for sedation in PICU. The main goal of the study is to demonstrate feasibility of a music trial in PICU and to obtain the necessary information to plan a larger trial. The study compares music versus noise cancelation versus control in sedated and mechanically ventilated children admitted to PICU. In the music group, children receive the music (modified classical music) three times a day for 30 min at a time. Music is delivered with noise cancelation headphones. The noise cancelation group receives the same intervention but with a no music (sham playlist). The control group receives usual care with no specific intervention. Children remain in the study until extubation or a maximum of 7 days. The primary outcomes of the study are feasibility and sedation/analgesia requirements. Secondary outcomes include change in vital signs before and during the intervention, ICU delirium, and adverse effects related to the intervention. The estimated sample size is 20 subjects per group for a total of 60 children.
DISCUSSION
Despite being recommended by current guidelines, evidence to support the use of music in PICU is lacking. Music has the potential to reduce sedation requirements and their negative side effects. This pilot RCT will demonstrate feasibility and provide the necessary information to plan a larger trial focusing on the effectiveness of the intervention.
TRIAL REGISTRATION
The study was registered at ClinicalTrials.gov (NCT03497559) on April 13, 2018.
背景
疼痛和焦虑引起的应激在儿科重症监护病房（PICU）患者中很常见。PICU中的镇静/镇痛通常通过各种镇痛药和镇静剂来实现。过度使用这些药物会使患者面临血流动力学/呼吸不稳定、通气时间延长、戒断反应、谵妄和危重病性多神经病的风险。镇静指南推荐使用非药物干预措施。然而，PICU中的非药物措施，包括音乐和降噪，尚未得到充分研究。
方法
危重症儿童音乐镇静（MUSiCC试验）初步研究是一项由研究者发起的、三臂、随机对照试验（RCT），旨在研究音乐在PICU镇静中的应用。该研究的主要目标是证明在PICU进行音乐试验的可行性，并获取规划更大规模试验所需的信息。该研究比较了音乐与噪音消除与对照组对入住PICU的镇静且机械通气儿童的效果。在音乐组中，儿童每天接受3次音乐（改编的古典音乐），每次30分钟。通过降噪耳机播放音乐。噪音消除组接受相同的干预，但播放无音乐的（假播放列表）。对照组接受常规护理，无特定干预。儿童留在研究中直至拔管或最长7天。该研究的主要结局是可行性和镇静/镇痛需求。次要结局包括干预前后生命体征的变化、ICU谵妄以及与干预相关的不良反应。估计样本量为每组20名受试者，共60名儿童。
讨论
尽管当前指南推荐使用音乐，但缺乏支持在PICU使用音乐的证据。音乐有可能降低镇静需求及其负面副作用。这项初步RCT将证明可行性，并提供必要信息以规划一项侧重于干预效果的更大规模试验。
试验注册
该研究于2018年4月13日在ClinicalTrials.gov（NCT03497559）注册。
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