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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: PICS; Post-ICU Patients
• Intervention / Treatment: Behavioral: Music intervention

• Study Type: Interventional
• Enrollment (Estimated): 9
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joanna Rickman, MSc, BSc; Phone Number: 0131 651 3969; Email: J.B.Rickman@sms.ed.ac.uk

Study Locations

• United Kingdom
  • Fife
    • Kirkcaldy, Fife, United Kingdom, KY2 5AH
      • NHS Fife
      • Contact: Joanna Rickman, MSc, BSc; Phone Number: 0131 651 3969; Email: J.B.Rickman@sms.ed.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: 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.
Active Comparator: 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.	Behavioral: 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.
Active Comparator: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in daily distress scores measured on the visual analogue scale 'Distress Thermometer'	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).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in severity of post-traumatic stress symptoms as measured by the Impact of Events Scale-Revised (IES-R).	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.	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).	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.	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).

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Collaborators: NHS Fife
• Investigators: Study Director: Satu Baylan, DClinPsy, PhD, BSc, University of Edinburgh

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: August 3, 2026
• First Submitted That Met QC Criteria: August 7, 2026
• First Posted (Actual): August 13, 2026

Study Record Updates

• Last Update Posted (Actual): August 13, 2026
• Last Update Submitted That Met QC Criteria: August 7, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: psychological distress; post-ICU; music-listening
• Other Study ID Numbers: CAHSS2601/02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No