Post-ICU PatientsMELODICNCT07762196
Measuring the Effects of Music-Listening On Distress After Intensive Care
A study testing Music intervention in people with Post-ICU Patients and PICS, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-ICU Patients, PICS
- What is being tested?
- Music intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Aug 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
NHS Fife
Kirkcaldy, Fife, KY2 5AH
Joanna Rickman, MSc, BSc, 0131 651 3969, J.B.Rickman@sms.ed.ac.uk
About this study
Official title: 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.
Read more
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
- Being tested
- Music intervention
- Keywords
- music-listening, post-ICU, psychological distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Music intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline, post-intervention (3-4 weeks depending on baseline allocation), and post-follow up (5-6 weeks depending on baseline allocation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start14 Aug 2026
- Primary completionJan 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-ICU PatientsStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Fife
- Responsible party
- Sponsor
- Investigators
- Satu Baylan, DClinPsy, PhD, BSc, Study director, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762196
- Sponsor's protocol ID
- CAHSS2601/02
- Acronym
- MELODIC
- Status last verified
- Sep 2026
- First submitted
- 3 Aug 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Effects of Music-Listening On Distress After Intensive Care (MELODIC): A Single Case Experimental Design Study.
- ClinicalTrials.gov ID
- NCT07762196
- Acronym / sponsor ID
- MELODIC / CAHSS2601/02
- Conditions
- Post-ICU Patients, PICS
- Keywords
- music-listening, post-ICU, psychological distress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Fife
- Study start
- 14 Aug 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Baseline period 5 days | Active comparator | Behavioral: Music interventionUp to 3 participants will be randomly allocated to a baseline phase of 5 days prior to starting the intervention phase of music-listening. |
| Baseline period of 8 days | Active comparator | Behavioral: Music interventionUp to 3 participants will be randomly allocated to a baseline phase of 8 days prior to starting the intervention phase of music-listening. |
| Baseline period of 12 days. | Active comparator | Behavioral: Music interventionUp to 3 participants will be randomly allocated to a baseline phase of 12 days prior to starting the intervention phase of music-listening. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music interventionTwo 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. | Behavioural | Baseline period 5 days, Baseline period of 12 days., Baseline period of 8 days |
Primary outcome
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.
4 secondary outcomes
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).
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).
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Satu Baylan, DClinPsy, PhD, BSc study director
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music intervention in people with Post-ICU Patients and PICS, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joanna Rickman, MSc, BSc (0131 651 3969, J.B.Rickman@sms.ed.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.