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Measuring the Effects of Music-Listening On Distress After Intensive Care (MELODIC)

2026年9月11日 更新者：University of Edinburgh

Measuring the Effects of Music-Listening On Distress After Intensive Care (MELODIC): A Single Case Experimental Design Study.

The primary goal of this single-case experimental design study is to investigate the effectiveness of personalised music listening on daily levels of distress after discharge from a critical care ward. The study will also aim to understand the effect of personalised music listening on symptoms of post-traumatic stress, anxiety, depression and health-related quality of life post-discharge.

The main questions the study aims to answer are included below.

After discharge from critical care, does personalised music-listening:

  • Reduce psychological distress?
  • Reduce symptoms of anxiety and depression?
  • Improve health-related quality of life (HRQoL)?

The study will have 3 phases, allowing for participant data gathered during the baseline phase (treatment as usual) to be compared to data gathered during intervention (music-listening) and follow-up phases.

Participants will:

  • rate their distress on a visual analogue scale each day.
  • listen to a minimum of 30 minutes of self-selected music each day during the intervention phase.
  • complete measures of mood, anxiety, post-traumatic stress and health-related quality of life at baseline, intervention and follow-up phases.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

9

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

学习地点

  • 英国
    • Fife
      • Kirkcaldy、Fife、英国、KY2 5AH

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:

  • 18 years or older.
  • Experienced an admission to an ICU/HDU of any length and not yet participated in InS:PIRE.
  • Access to an internet-enabled device and internet connection whilst at home.
  • Experiencing some distress relating to their ICU/HDU admission - a cut-off score of 4 on the VAS 'Distress Thermometer' has been used previously (Hofhuis et al., 2025).

Exclusion Criteria:

  • Are unable to give informed consent e.g. have a significant cognitive impairment due to illness, injury or neurological condition, or are currently experiencing delirium or acute psychotic illness.
  • Have significant communication difficulties or limited English and cannot access validated outcome measures or translation services in the given language.
  • Are experiencing a mental health crisis or have recently attempted suicide, where ongoing significant risk of harm to themselves or others remains.
  • Have an uncorrected hearing impairment that would prevent them from hearing their music playlist.
  • Are participating in another study aimed at reducing distress.

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：治疗
  • 分配：随机化
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Baseline period 5 days
Up to 3 participants will be randomly allocated to a baseline phase of 5 days prior to starting the intervention phase of music-listening.
行为的：Music intervention
Two week personalised music listening intervention, with daily self-directed listening for a minimum of 30 minutes per day. Participants will meet with researcher after first week to review the listening material.
有源比较器：Baseline period of 8 days
Up to 3 participants will be randomly allocated to a baseline phase of 8 days prior to starting the intervention phase of music-listening.
行为的：Music intervention
Two week personalised music listening intervention, with daily self-directed listening for a minimum of 30 minutes per day. Participants will meet with researcher after first week to review the listening material.
有源比较器：Baseline period of 12 days.
Up to 3 participants will be randomly allocated to a baseline phase of 12 days prior to starting the intervention phase of music-listening.
行为的：Music intervention
Two week personalised music listening intervention, with daily self-directed listening for a minimum of 30 minutes per day. Participants will meet with researcher after first week to review the listening material.

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
Change in daily distress scores measured on the visual analogue scale 'Distress Thermometer'
大体时间：Daily from enrolment to the end of the follow-up phase (5-6 weeks depending on baseline allocation).
Distress Thermometer rates distress on a scale of 0-10, where 0 is equivalent to no distress and 10 indicates the worst possible distress.
Daily from enrolment to the end of the follow-up phase (5-6 weeks depending on baseline allocation).

次要结果测量

结果测量
措施说明
大体时间
Changes in severity of post-traumatic stress symptoms as measured by the Impact of Events Scale-Revised (IES-R).
大体时间：Baseline, post-intervention (3-4 weeks depending on baseline allocation), and post-follow up (5-6 weeks depending on baseline allocation).
The IES-R is a 22-item self-report measure capturing intrusive, avoidant and hyperarousal symptoms of PTS. The IES-R evaluates how distressed the individual has been by their symptoms over the past week rated on a Likert scale of 0 (not at all) to 4 (extremely).
Baseline, post-intervention (3-4 weeks depending on baseline allocation), and post-follow up (5-6 weeks depending on baseline allocation).
Changes in anxiety symptom severity as measured by the Generalised Anxiety Disorder (GAD-7) scale.
大体时间：Baseline, post-intervention (3-4 weeks depending on baseline allocation), and post-follow up (5-6 weeks depending on baseline allocation).
The GAD-7 is a 7-item measure of anxiety and worry where participants are asked to rate from 0 (not at all) to 3 (nearly every day) how often they were bothered by difficulties in the past 2 weeks. The measure has cut-off scores suggesting mild (5-9), moderate (10-14) and severe (15-21) anxiety, with scores above 10 considered within the clinical range for an anxiety disorder. Clinically significant change is considered to be a reduction in at least 4 points.
Baseline, post-intervention (3-4 weeks depending on baseline allocation), and post-follow up (5-6 weeks depending on baseline allocation).
Changes in depression symptom severity as measured by the Patient Health Questionnaire (PHQ-9).
大体时间：Baseline, post-intervention (3-4 weeks depending on baseline allocation), and post-follow up (5-6 weeks depending on baseline allocation).
The PHQ-9 is a 9-item measure of depression where participants rate from 0 (not at all) to 3 (nearly every day) how often they had been bothered by depressive symptoms in the past 2 weeks. Total score interpretations are none-minimal (0-4), mild (5-9), moderate (10-14), moderately-severe (15-19) or severe depression (20-27). Again, scores above 10 are considered in the clinical range. Clinically significant change is considered to be a reduction in 6 or more points.
Baseline, post-intervention (3-4 weeks depending on baseline allocation), and post-follow up (5-6 weeks depending on baseline allocation).
Changes in Health-Related Quality of Life (EQ-5D-5L) scores.
大体时间：Baseline, post-intervention (3-4 weeks depending on baseline allocation), and post-follow up (5-6 weeks depending on baseline allocation).
The EQ-5D-5L is a short measure of HRQoL which descriptively scores responses to questions across dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety/depression and provides a 5 digit code describing participants health state. Participants are also asked to rate their overall current health on a visual analogue scale between 0 (worst health you can imagine) to 100 (best health you can imagine).
Baseline, post-intervention (3-4 weeks depending on baseline allocation), and post-follow up (5-6 weeks depending on baseline allocation).

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

University of Edinburgh

合作者

NHS Fife

调查人员

  • 研究主任：Satu Baylan, DClinPsy, PhD, BSc、University of Edinburgh

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 (实际的)

2026年8月14日

初级完成 (估计的)

2027年1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8月3日

首先提交符合 QC 标准的

2026年8月7日

首次发布 (实际的)

2026年8月13日

研究记录更新

最后更新发布 (实际的)

2026年9月16日

上次提交的符合 QC 标准的更新

2026年9月11日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • CAHSS2601/02

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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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