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

August 7, 2026 updated by: University of Edinburgh

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Daily from enrolment to the end of the follow-up phase (5-6 weeks depending on baseline allocation).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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).
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).
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.
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.
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).
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.
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.
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).
Baseline, post-intervention (3-4 weeks depending on baseline allocation), and post-follow up (5-6 weeks depending on baseline allocation).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Edinburgh

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
NHS Fife

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Satu Baylan, DClinPsy, PhD, BSc, University of Edinburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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