Khan Sikandar H, Wang Sophia, Harrawood Amanda, Martinez Stephanie, Heiderscheit Annie, Chlan Linda, Perkins Anthony J, Tu Wanzhu, Boustani Malaz, Khan Babar
Division of Pulmonary, Critical Care, Sleep and Occupational Medicine, Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA.
IU Center of Aging Research, Regenstrief Institute, Indianapolis, IN, USA.
Trials. 2017 Nov 29;18(1):574. doi: 10.1186/s13063-017-2324-6.
Delirium is a highly prevalent and morbid syndrome in intensive care units (ICUs). Changing the stressful environment within the ICU via music may be an effective and a scalable way to reduce the burden of delirium.
METHODS/DESIGN: The Decreasing Delirium through Music (DDM) study is a three-arm, single-blind, randomized controlled feasibility trial. Sixty patients admitted to the ICU with respiratory failure requiring mechanical ventilation will be randomized to one of three arms (20 participants per arm): (1) personalized music, (2) non-personalized relaxing music, or (3) attention-control. Music preferences will be obtained from all enrolled participants or their family caregivers. Participants will receive two 1-h audio sessions a day through noise-cancelling headphones and mp3 players. Our primary aim is to determine the feasibility of the trial design (recruitment, adherence, participant retention, design and delivery of the music intervention). Our secondary aim is to estimate the potential effect size of patient-preferred music listening in reducing delirium, as measured by the Confusion Assessment Method for the ICU (CAM-ICU). Participants will receive twice daily assessments for level of sedation and presence of delirium. Enrolled participants will be followed in the hospital until death, discharge, or up to 28 days, and seen in the Critical Care Recovery Clinic at 90 days.
DDM is a feasibility trial to provide personalized and non-personalized music interventions for critically ill, mechanically ventilated patients. Our trial will also estimate the preliminary efficacy of music interventions on reducing delirium incidence and severity.
ClinicalTrials.gov, Identifier: NCT03095443 . Registered on 23 March 2017.
谵妄是重症监护病房（ICU）中一种非常普遍且具有危害性的综合征。通过音乐改变ICU内的应激环境可能是减轻谵妄负担的一种有效且可扩展的方法。
方法/设计：通过音乐减少谵妄（DDM）研究是一项三臂、单盲、随机对照可行性试验。60例因呼吸衰竭需要机械通气而入住ICU的患者将被随机分为三组（每组20名参与者）：（1）个性化音乐组，（2）非个性化放松音乐组，或（3）注意力控制组。将从所有登记参与者或其家庭护理人员处获取音乐偏好。参与者将通过降噪耳机和mp3播放器每天接受两次1小时的音频播放。我们的主要目的是确定试验设计的可行性（招募、依从性、参与者保留率、音乐干预的设计和实施）。我们的次要目的是估计患者偏好的音乐聆听在减少谵妄方面的潜在效应大小，通过ICU谵妄评估方法（CAM-ICU）进行测量。参与者将每天接受两次镇静水平和谵妄存在情况的评估。登记的参与者将在医院随访至死亡、出院或长达28天，并在90天时在重症监护恢复诊所接受检查。
DDM是一项可行性试验，为重症机械通气患者提供个性化和非个性化音乐干预。我们的试验还将估计音乐干预对降低谵妄发生率和严重程度的初步疗效。
ClinicalTrials.gov，标识符：NCT03095443。于2017年3月23日注册。
