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NCT Number: NCT07762196

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

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.

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Key information

Conditions

Post-ICU Patients PICS

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Music intervention

Behavioral

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.

Primary outcomes

  1. Change in daily distress scores measured on the visual analogue scale 'Distress Thermometer'

    Time frame: 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.

Secondary outcomes

  1. Changes in severity of post-traumatic stress symptoms as measured by the Impact of Events Scale-Revised (IES-R).

    Time frame: 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).

  2. Changes in anxiety symptom severity as measured by the Generalised Anxiety Disorder (GAD-7) scale.

    Time frame: 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.

  3. Changes in depression symptom severity as measured by the Patient Health Questionnaire (PHQ-9).

    Time frame: 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.

  4. Changes in Health-Related Quality of Life (EQ-5D-5L) scores.

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Joanna Rickman, MSc, BSc

CONTACT

[email protected]

0131 651 3969

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • NHS Fife

Registry information

Official study title

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

Acronym: MELODIC

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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