Department of Medicine, IU School of Medicine, Indianapolis, IN, USA.
IU Center of Aging Research, Regenstrief Institute, Indianapolis, IN, USA.
Trials. 2022 Jul 19;23(1):576. doi: 10.1186/s13063-022-06448-w.
Delirium is a highly prevalent and morbid syndrome in mechanically ventilated intensive care unit (ICU) patients. Music is a promising non-pharmacological intervention with beneficial effects on anxiety and stress, while its effects on delirium duration and severity are not well understood.
METHODS/DESIGN: Our study is a two-arm, randomized parallel-group, clinical trial to evaluate the efficacy of music intervention compared to a silence-track attention control on delirium/coma duration in mechanically ventilated critically ill older adults. One hundred sixty mechanically ventilated adults 50 years of age or older will be randomized to one of two arms within 72 h of ICU admission: (1) 1-h music listening sessions twice daily through noise-canceling headphones, or (2) 1-h sessions of a silence track twice daily through noise-canceling headphones. Our primary aim is to compare delirium/coma-free days after randomization during the 7-day study intervention phase using the Confusion Assessment Method for the ICU (CAM ICU) and the Richmond Agitation Sedation Scale (RASS) for delirium and coma. Secondary outcomes include pain and anxiety evaluated twice daily during the intervention phase and throughout the duration of ICU stay using the Critical Care Pain Observation Tool (CPOT) and visual analog scale-anxiety (VAS-A). Enrolled participants will be followed after hospital discharge to further measure cognition as well as screening for depression and anxiety using the following telephone-based instruments: Indiana University Telephone-Based Assessment of Neuropsychological Status (IU TBANS), Patient Health Questionnaire-9 (PHQ-9), and Generalized Anxiety Disorder-7 (GAD-7).
This randomized clinical trial will measure the efficacy of a music listening intervention for delirium and coma duration early in the intensive care unit among older adults.
ClinicalTrials.gov. NCT04182334 .
谵妄是机械通气重症监护病房（ICU）患者中一种高发且病态的综合征。音乐是一种很有前途的非药物干预措施，对焦虑和压力有有益的影响，但其对谵妄持续时间和严重程度的影响尚不清楚。
方法/设计：我们的研究是一项两臂、随机平行组、临床试验，旨在评估与安静音乐对照相比，音乐干预对机械通气的老年重症患者谵妄/昏迷持续时间的疗效。160 名 50 岁或以上的机械通气成年人将在 ICU 入院后 72 小时内随机分配到两个臂中的一个：（1）每天两次通过降噪耳机听 1 小时音乐，或（2）每天两次通过降噪耳机听 1 小时的安静音乐。我们的主要目的是使用 ICU 意识模糊评估法（CAM-ICU）和 Richmond 躁动镇静量表（RASS）比较随机分组后第 7 天研究干预期内的谵妄/昏迷无天数。次要结局包括在干预期内每天两次评估疼痛和焦虑，并在 ICU 住院期间使用重症监护疼痛观察工具（CPOT）和视觉模拟焦虑量表（VAS-A）进行评估。纳入的参与者将在出院后进行随访，进一步测量认知，并使用以下基于电话的仪器筛查抑郁和焦虑：印第安纳大学基于电话的神经心理状态评估（IU-TBANS）、患者健康问卷-9（PHQ-9）和广泛性焦虑障碍-7（GAD-7）。
这项随机临床试验将在老年人 ICU 早期测量音乐聆听干预对谵妄和昏迷持续时间的疗效。
ClinicalTrials.gov。NCT04182334。
