Measuring the Effects of Music-Listening On Distress After Intensive Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Edinburgh
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Music intervention
BehavioralTwo 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.
Treatment groups
9 Participants
are divided into 3 treatment groupsGroup A: Baseline period 5 daysActive comparator 1 intervention
Group B: Baseline period of 8 daysActive comparator 1 intervention
Group C: Baseline period of 12 days.Active comparator 1 intervention
Trial outcomes
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.
Time frame
Daily from enrolment to the end of the follow-up phase (5-6 weeks depending on baseline allocation).Secondary outcomes
1
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).
Time frame
Baseline, post-intervention (3-4 weeks depending on baseline allocation), and post-follow up (5-6 weeks depending on baseline allocation).2
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.
Time frame
Baseline, post-intervention (3-4 weeks depending on baseline allocation), and post-follow up (5-6 weeks depending on baseline allocation).3
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.
Time frame
Baseline, post-intervention (3-4 weeks depending on baseline allocation), and post-follow up (5-6 weeks depending on baseline allocation).4
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).
Time frame
Baseline, post-intervention (3-4 weeks depending on baseline allocation), and post-follow up (5-6 weeks depending on baseline allocation).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Edinburgh
Lead sponsor
NHS Fife
Collaborator
Source ClinicalTrials.gov