Measuring the Effects of Music-Listening On Distress After Intensive Care (NCT07762196) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Measuring the Effects of Music-Listening On Distress After Intensive Care
United Kingdom9 participantsStarted 2026-08
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in daily distress scores measured on the visual analogue scale 'Distress Thermometer'
Timeframe: Daily from enrolment to the end of the follow-up phase (5-6 weeks depending on baseline allocation).