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Effects of Different Types of Music Therapy Combined With Mindful Breathing on Delirium, Pain, and Anxiety in ICU Patients

2026年5月31日 更新者:Chimei Medical Center
Delirium is the most common and severe neuropsychiatric complication in the Intensive Care Unit (ICU), with an incidence as high as 87% in the United States, 75.6% in medical ICUs in Taiwan, and 41.7% in surgical ICUs, with patients developing delirium an average of 2.6 days after admission. Delirium is associated with prolonged mechanical ventilation, increased complications, higher in-hospital mortality, greater psychological burden on family members, and elevated clinical pressure on healthcare staff. The National Institute for Health and Care Excellence (NICE) guidelines recommend prioritizing non-pharmacological interventions for delirium prevention, among which music intervention has emerged as one of the most promising strategies due to its low risk, low cost, and feasibility in the ICU setting. Although several international studies have supported its potential benefits, evidence remains inconclusive. Mindfulness-based approaches represent another non-pharmacological strategy that intentionally directs attention to present-moment bodily sensations; mindful breathing exercises are particularly suitable for ICU patients, as they only require patients to adopt a comfortable position in bed and focus on each inhalation and exhalation under guidance, quickly restoring awareness to present bodily experience. Incorporating mindful breathing before and after music listening may therefore facilitate emotional regulation and present-moment awareness, enhancing patient engagement and attentional focus during the intervention. Existing delirium prevention studies in Taiwan have predominantly employed multicomponent care bundles, leaving a gap in empirical evidence regarding music as a standalone intervention. Moreover, scholars have highlighted that musical preference and cultural background influence patients' psychological responses to music, underscoring the importance of cultural appropriateness. In response to this gap, the present study proposes a music intervention combining classical music and Taiwan-localized music with mindful breathing exercises, aiming to examine the effects on ICU delirium incidence and severity, compare the effectiveness of classical versus Taiwan-localized music, and explore the potential benefits on patient anxiety and pain, with the hope of providing a culturally informed, evidence-based music repertoire to guide clinical practice in Taiwan.

研究概览

详细说明

Delirium is the most common and severe neuropsychiatric symptom occurring in Intensive Care Units (ICUs). Research in the United States indicates that the incidence of ICU delirium can reach as high as 87%. In Taiwan, the incidence rate is 75.6% in medical ICUs and 41.7% in surgical ICUs. On average, patients develop delirium 2.6 days after admission. Delirium not only negatively impacts patients-leading to prolonged mechanical ventilation, increased complications, and higher hospital mortality rates-but also increases the physical and mental burden on family members and the clinical pressure on healthcare staff. The National Institute for Health and Care Excellence (NICE) guidelines recommend prioritizing non-pharmacological interventions to prevent delirium. Among these interventions, music is considered one of the most promising approaches because it is low risk, low cost, and easy to implement in the ICU setting. Several international studies have supported the potential benefits of music listening for delirium prevention; however, the effectiveness of such interventions remains inconclusive. Mindfulness is another non-pharmacological strategy that intentionally redirects attention to present-moment bodily sensations. Among various mindfulness practices, mindful breathing exercises are particularly suitable for ICU patients. Patients only need to adopt a comfortable position in bed and, under guidance, focus their attention on each inhalation and exhalation, which can quickly bring their awareness back to the present sensations of the body. Incorporating mindful breathing exercises into the procedures before and after music listening may serve as an adjunct to facilitate emotional regulation and awareness of present-moment experience, thereby enhancing patients' engagement and attentional focus during the music-listening context.

In Taiwan, existing studies on delirium prevention have mainly employed multicomponent care bundles, and empirical evidence on music as a single intervention remains lacking. Given that scholars at home and abroad have indicated that musical preference and national culture influence patients' psychological responses to music, and in view of the aforementioned research gap as well as clinical feasibility and utility, this study proposes to use classical music and Taiwan-localized music as intervention modalities, combined with mindful breathing exercises before and after music listening. The study will examine the effects of different types of music on the occurrence and severity of delirium, and further compare the intervention effectiveness of classical versus Taiwan-localized music, as well as explore their potential benefits for anxiety and pain. It is hoped that this work will fill the current gap in research on music-based interventions for ICU patients with delirium in Taiwan and provide an evidence-based repertoire of music selections for clinical practice.

研究类型

介入性

注册 (估计的)

51

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Adults aged 20 years or older who can communicate verbally or in writing
  • Able to receive music therapy
  • Pain score > 2 within the past 24 hours
  • Delirium prediction model risk > 20%

Exclusion Criteria:

  • Positive delirium screening at ICU admission
  • Significant hearing impairment
  • Inability to cooperate with wearing over-the-ear headphones

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
无干预:控制组
实验性的:Taiwan-localized music group
Participants in the Taiwan-localized music groups will receive Mindful Breathing Combined with Music Listening sessions per day.
实验性的:Classical music group
Participants in the Classical music groups will receive Mindful Breathing Combined with Music Listening sessions per day.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Incidence and severity of delirium assessed by CAM-ICU-7
大体时间:Twice daily (at 09:00 and 17:00) for 5 consecutive days (from Day 1 to Day 5)
Delirium severity will be measured using the Confusion Assessment Method for the ICU 7-item scale (CAM-ICU-7). The total score ranges from 0 to 7, with higher scores indicating greater delirium severity. Measurements will be taken twice daily (at 09:00 and 17:00) during the 5-day intervention period.
Twice daily (at 09:00 and 17:00) for 5 consecutive days (from Day 1 to Day 5)

次要结果测量

结果测量
措施说明
大体时间
Pain intensity assessed by the Critical-Care Pain Observation Tool (CPOT)
大体时间:Twice daily (at 09:00 and 17:00) for 5 consecutive days (from Day 1 to Day 5)
The Critical-Care Pain Observation Tool (CPOT) will be used to assess pain behavioral indicators in ICU patients. The tool includes four domains: facial expression, body movements, muscle tension, and compliance with the ventilator (or vocalization for extubated patients). The total score ranges from 0 to 8, with higher scores indicating a higher level of pain intensity.
Twice daily (at 09:00 and 17:00) for 5 consecutive days (from Day 1 to Day 5)
Anxiety level assessed by the Faces Anxiety Scale (FAS)
大体时间:Twice daily (at 09:00 and 17:00) for 5 consecutive days (from Day 1 to Day 5)
The Faces Anxiety Scale (FAS) will be used to measure the self-reported anxiety level of ICU patients. The scale consists of 5 faces showing progressive levels of anxiety. The total score ranges from 0 (no anxiety) to 4 (severe anxiety), with higher scores indicating a higher level of anxiety.
Twice daily (at 09:00 and 17:00) for 5 consecutive days (from Day 1 to Day 5)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2026年10月31日

研究完成 (估计的)

2027年4月9日

研究注册日期

首次提交

2026年5月22日

首先提交符合 QC 标准的

2026年5月31日

首次发布 (实际的)

2026年6月3日

研究记录更新

最后更新发布 (实际的)

2026年6月3日

上次提交的符合 QC 标准的更新

2026年5月31日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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