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Effects of Music Therapy on Anxiety Symptoms in Patients With Prolonged Mechanical Ventilation: A Randomized Controlled Trial

2026年4月24日 更新者：Shi Songqi、Capital Medical University

The purpose of this study is to evaluate the effects of music therapy on anxiety symptoms in patients requiring prolonged mechanical ventilation (PMV). PMV patients, defined as those ventilated for more than 21 days, often experience intense psychological stress and anxiety due to long-term intubation and the ICU environment. High anxiety can lead to "patient-ventilator asynchrony," which delays the weaning process.

In this study, 200 participants will be randomly assigned to either a control group receiving standard care or an experimental group receiving patient-directed music therapy. The music therapy intervention involves listening to selected music through noise-canceling headphones for 30 minutes, twice daily, over a 14-day period. The study will measure improvements in anxiety levels, pain, and sleep quality to determine if music therapy can help break the cycle of anxiety and facilitate recovery.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

This is a prospective, single-blind, multi-center randomized controlled trial conducted at Beijing Rehabilitation Hospital and two collaborating medical institutions. Eligible participants are patients aged 50 or older who meet the diagnostic criteria for prolonged mechanical ventilation (ventilation duration ≥ 21 days for at least 6 hours per day).

Intervention Protocols:

Experimental Group: Participants will receive "Patient-Directed" music therapy in addition to standard ICU/rehabilitation care. A digital music library featuring classical, nature sounds, light pop, and traditional Chinese folk music (60-80 bpm) will be used. Music is delivered via medical-grade noise-canceling headphones at a volume of 60-70 decibels for 30 minutes, twice daily (10:00-11:00 and 15:00-16:00), for a total of 14 days.

Control Group: Participants will receive standard care and environmental control (noise and light management). To minimize bias, the interaction time between nursing staff and patients in the control group will be identical to that in the experimental group.

Outcome Measures:

Primary Outcome: Improvement in anxiety severity measured by the Visual Analog Scale for Anxiety (VAS-A) and the State-Trait Anxiety Inventory (STAI-S).

Secondary Outcomes: Pain levels assessed by the Critical-Care Pain Observation Tool (CPOT), sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI), and successful extubation rates.

Statistical Analysis: Data will be analyzed using SPSS 26.0 and R 4.3. Linear Mixed Models (LMM) or Generalized Estimating Equations (GEE) will be employed to evaluate longitudinal changes across four time points: baseline (T0), day 3 (T1), day 7 (T2), and day 14 (T3).

研究类型

介入性

注册 (估计的)

200

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Songqi Shi, Bachelor of Science
  • 电话号码：+86-18601258786
  • 邮箱：1499913759@qq.com

研究联系人备份

  • 姓名：Hongying Jiang, Ph.D.
  • 电话号码：+86-10-56981067

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100144
        • Beijing Rehabilitation Hospital, Capital Medical University
        • 接触：
          • Songqi Shi, Bachelor of Science
          • 电话号码：+86-18601258786
          • 邮箱：1499913759@qq.com
        • 接触：
          • Hongying Jiang, Ph.D.
          • 电话号码：+86-10-56981067

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:

- 1、Age > 50 years 2、Diagnosed with Prolonged Mechanical Ventilation (PMV), meeting the following criteria: Continuous mechanical ventilation for ≥ 21 days Daily mechanical ventilation duration ≥ 6 hours Ventilation via endotracheal tube, tracheostomy, or non-invasive interface (face/nasal mask).

3、Voluntarily signed the informed consent form (either by the patient or their legal representative).

Exclusion Criteria:

  • 1、Cognitive or psychiatric disorders: history of severe mental illness (e.g., schizophrenia, severe depression, bipolar disorder) or diagnosed moderate-to-severe dementia/cognitive impairment.

    2、Presence of delirium: assessed as positive by the Confusion Assessment Method for the ICU (CAM-ICU) prior to enrollment.

    3、Extreme hemodynamic instability: unstable vital signs requiring frequent resuscitation, or in the acute phase of a severe cardio-cerebrovascular accident.

    4、Untreated hearing impairment. 5、Physical conditions preventing safe earphone use (e.g., skin damage, burns, facial or cranial fractures).

    6、Poor prognosis: end-stage disease or assessed by the investigator as having a life expectancy insufficient to complete the intervention and follow-up period.

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：支持治疗
  • 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
实验性的：Experimental: Music Therapy Group
Participants will receive patient-directed music therapy (PDMT) in addition to standard respiratory ICU/rehabilitation care and environmental control.
其他：Patient-Directed Music Therapy (PDMT)

Music Selection: Patients or families select genres (classical, nature sounds, light pop, or traditional Chinese folk) with a tempo of 60-80 bpm.

Equipment: Medical-grade noise-canceling headphones. Dosage: 30 minutes per session, twice daily (10:00-11:00 and 15:00-16:00) for 14 consecutive days.

Volume: Limited to 60-70 decibels.

其他：Environmental Control and Matched Interaction

Environmental Control: Minimizing noise and light interference in the ward, using silent earplugs and eyemasks when necessary.

Matched Interaction: Nursing staff will spend the same amount of bedside time with control group patients as they do with the music therapy group to ensure consistency in care-related interaction.
有源比较器：Active Comparator: Control Group
Participants will receive standard respiratory ICU/rehabilitation care, including routine analgesia/sedation management, mechanical ventilation adjustment, and basic psychological support. They will also receive environmental control (noise and light management) and matched nurse bedside interaction time to control for the Hawthorne effect.
其他：Environmental Control and Matched Interaction

Environmental Control: Minimizing noise and light interference in the ward, using silent earplugs and eyemasks when necessary.

Matched Interaction: Nursing staff will spend the same amount of bedside time with control group patients as they do with the music therapy group to ensure consistency in care-related interaction.

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
Improvement in Anxiety Severity
大体时间：Change from Baseline (T0) to Day 14 of intervention (T3)
Measured by the Visual Analog Scale for Anxiety (VAS-A) and the State-Trait Anxiety Inventory-State (STAI-S) 。VAS-A is a 0-10 cm scale where higher scores indicate higher anxiety levels. STAI-S is a 20-item scale assessing current state anxiety 。
Change from Baseline (T0) to Day 14 of intervention (T3)

次要结果测量

结果测量
措施说明
大体时间
Pain Severity
大体时间：Baseline (T0), Day 3 (T1), Day 7 (T2), and Day 14 (T3)
Assessed using the Critical-Care Pain Observation Tool (CPOT)
Baseline (T0), Day 3 (T1), Day 7 (T2), and Day 14 (T3)
Sleep Quality
大体时间：Baseline (T0) and Day 14 (T3)
Measured by the Pittsburgh Sleep Quality Index (PSQI)
Baseline (T0) and Day 14 (T3)
Successful Extubation Rate
大体时间：Up to Day 14 or discharge from ICU
The percentage of patients who successfully remain extubated for at least 48 hours without requiring re-intubation
Up to Day 14 or discharge from ICU

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。

赞助

Capital Medical University

调查人员

  • 研究主任：Hongying Jiang、Beijing Rehabilitation Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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5月1日

初级完成 (估计的)

2027年4月1日

研究完成 (估计的)

2027年5月1日

研究注册日期

首次提交

2026年4月24日

首先提交符合 QC 标准的

2026年4月24日

首次发布 (实际的)

2026年5月1日

研究记录更新

最后更新发布 (实际的)

2026年5月1日

上次提交的符合 QC 标准的更新

2026年4月24日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2026bkky-051

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

"Individual participant data will not be shared to protect participant privacy and maintain confidentiality, as stated in the study protocol and informed consent approved by the Ethics Committee."

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

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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