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

NCT07762196 | Not Yet Recruiting

• 1 other identifier: CAHSS2601/02
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-ICU Patients; PICS

Keywords

music-listening; post-ICU; psychological distress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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).

Study Arms (3)

Baseline period 5 days

ACTIVE COMPARATOR

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

Baseline period of 8 days

ACTIVE COMPARATOR

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

Baseline period of 12 days.

ACTIVE COMPARATOR

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

Interventions

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.

Baseline period 5 days; Baseline period of 12 days.; Baseline period of 8 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Fife: collaborator

Study Sites (1)

NHS Fife

Kirkcaldy, Fife, KY2 5AH, United Kingdom

Location

Study Officials

• Satu Baylan, DClinPsy, PhD, BSc

  University of Edinburgh

  STUDY DIRECTOR

Central Study Contacts

Joanna Rickman, MSc, BSc

CONTACT

0131 651 3969; J.B.Rickman@sms.ed.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Single Case Experimental Design (SCED) methodology using a Multiple Baseline Design (MBD) will be used. The SCED will include 3 phases: baseline (A), intervention (B) and follow-up (C). Using a MBD means the baseline length will be randomised across participants, allowing each participant to be their own control, and increasing confidence in outcomes being the result of the intervention. Participants will be randomly allocated to baselines of 5, 8 or 12 days using an online randomisation tool, followed by a 2-week music-listening intervention phase, and a 2-week follow-up phase.

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 13, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)