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围手术期音乐对髋部骨折手术后谵妄的影响(MCHOPIN):荷兰医院的一项多中心随机临床试验

Effect of perioperative music on delirium after hip fracture operations (MCHOPIN): a multicentre randomised clinical trial in Dutch hospitals.

作者信息

Dirven Thomas LA, Fu Victor X, Becker Antonia S, Andrinopoulou Eleni-Rosalina, Kalisvaart Kees, Jeekel Johannes, Klimek Markus, Verhofstad Michael Hj

机构信息

Department of Neuroscience, Erasmus MC, Rotterdam, The Netherlands

Department of Neuroscience, Erasmus MC, Rotterdam, The Netherlands.

出版信息

BMJ Open. 2025 Aug 28;15(8):e095819. doi: 10.1136/bmjopen-2024-095819.

Abstract

OBJECTIVES

Postoperative delirium is a frequent complication with possible detrimental consequences in older hip fracture patients. Music interventions are promising, with positive effects on risk factors for delirium. This study aimed to assess the impact of perioperative music on postoperative delirium in older hip fracture patients.

DESIGN

Prospective randomised controlled trial.

SETTING

Multicentre study, performed in six participating hospitals in the Netherlands.

PARTICIPANTS

Eligibility criteria included patients aged ≥65 years with an acute hip fracture requiring surgery and documented informed consent. 449 patients were randomised, with a median age of 81 years (IQR 74-87), including 287 women (63.9%).

INTERVENTIONS

Music group participants received the intervention preoperatively, intraoperatively, and postoperatively twice a day for 30 min. The control group received standard-of-care, supplemented by headphones without music intraoperatively for equal noise reduction in both groups.

PRIMARY AND SECONDARY OUTCOME MEASURES

The primary outcome was delirium diagnosis (Diagnostic and Statistical Manual of Mental Disorders, fifth edition), assessed by a geriatrician. Associations were analysed using regression models. Secondary outcomes included: Delirium Observational Score, anxiety, pain and postoperative complications.

RESULTS

Intention-to-treat analysis showed no statistically significant decrease of delirium in the music group, compared with the control group (OR 0.685 (95% CI 0.378 to 1.242); p=0.21). However, in the modified-intention-to-treat analysis, a significant decrease in postoperative delirium was observed (OR 0.478 (95% CI 0.245 to 0.933); p=0.028), which is substantiated by a logistic regression (OR 0.43 (95 % CI 0.19 to 0.98); p=0.045). Also, more postoperative complications were observed in the control group (93 (43.3%); 66 (32.7); p=0.026) in this analysis. The intervention was associated with high patient satisfaction and no adverse events.

CONCLUSIONS

This study suggests a positive effect of music interventions on postoperative delirium, which provides additional evidence for considering the implementation of these interventions in hip fracture care.

TRIAL REGISTRATION NUMBER

International Clinical Trial Registry Platform, Dutch Trial Register (www.onderzoekmetmensen.nl/, ID:NTR7036).

摘要

目的

术后谵妄是老年髋部骨折患者常见的并发症,可能产生有害后果。音乐干预颇具前景,对谵妄的危险因素有积极影响。本研究旨在评估围手术期音乐对老年髋部骨折患者术后谵妄的影响。

设计

前瞻性随机对照试验。

设置

多中心研究,在荷兰的六家参与医院进行。

参与者

纳入标准包括年龄≥65岁、急性髋部骨折需手术且有书面知情同意书的患者。449例患者被随机分组,中位年龄81岁(四分位间距74 - 87岁),其中287例为女性(63.9%)。

干预措施

音乐组参与者在术前、术中和术后每天接受两次干预,每次30分钟。对照组接受标准护理,术中佩戴无音乐的耳机以保证两组降噪程度相同。

主要和次要结局指标

主要结局为谵妄诊断(《精神疾病诊断与统计手册》第五版),由老年病科医生评估。使用回归模型分析相关性。次要结局包括:谵妄观察评分、焦虑、疼痛和术后并发症。

结果

意向性分析显示,与对照组相比,音乐组谵妄发生率无统计学显著降低(比值比0.685(95%置信区间0.378至1.242);p = 0.21)。然而,在修正意向性分析中,观察到术后谵妄有显著降低(比值比0.478(95%置信区间0.245至0.933);p = 0.028),逻辑回归也证实了这一点(比值比0.43(95%置信区间0.19至0.98);p = 0.045)。此外,在此分析中,对照组术后并发症更多(93例(43.3%);66例(32.7%);p = 0.026)。该干预措施患者满意度高且无不良事件。

结论

本研究表明音乐干预对术后谵妄有积极作用,为在髋部骨折护理中考虑实施这些干预措施提供了更多证据。

试验注册号

国际临床试验注册平台,荷兰试验注册库(www.onderzoekmetmensen.nl/,ID:NTR7036)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c8e5/12406818/fdc286d67098/bmjopen-15-8-g001.jpg

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