Measuring the Effects of Music-Listening On Distress After Intensive Care (MELODIC): A Single Case Experimental Design Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Change in daily distress scores measured on the visual analogue scale 'Distress Thermometer'
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Music intervention (Behavioral)
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.
干预措施: Music intervention (Behavioral)
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.
干预措施: Music intervention (Behavioral)
结局指标
主要结局
Change in daily distress scores measured on the visual analogue scale 'Distress Thermometer'
时间窗: 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.
次要结局
- Changes in severity of post-traumatic stress symptoms as measured by the Impact of Events Scale-Revised (IES-R).(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.(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).(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.(Baseline, post-intervention (3-4 weeks depending on baseline allocation), and post-follow up (5-6 weeks depending on baseline allocation).)