Measuring the Effects of Music-Listening On Distress After Intensive Care (MELODIC)
11. september 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
9
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Joanna Rickman, MSc, BSc
- Telefonnummer: 0131 651 3969
- E-post: J.B.Rickman@sms.ed.ac.uk
Studiesteder
-
-
Fife
-
Kirkcaldy, Fife, Storbritannia, KY2 5AH
- Rekruttering
- NHS Fife
-
Ta kontakt med:
- Joanna Rickman, MSc, BSc
- Telefonnummer: 0131 651 3969
- E-post: J.B.Rickman@sms.ed.ac.uk
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
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.
|
|
Aktiv komparator: 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.
|
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.
|
|
Aktiv komparator: 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.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in daily distress scores measured on the visual analogue scale 'Distress Thermometer'
Tidsramme: 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).
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in severity of post-traumatic stress symptoms as measured by the Impact of Events Scale-Revised (IES-R).
Tidsramme: 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.
Tidsramme: 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).
Tidsramme: 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.
Tidsramme: 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).
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Satu Baylan, DClinPsy, PhD, BSc, University of Edinburgh
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
14. august 2026
Primær fullføring (Antatt)
1. januar 2027
Studiet fullført (Antatt)
1. mai 2027
Datoer for studieregistrering
Først innsendt
3. august 2026
Først innsendt som oppfylte QC-kriteriene
7. august 2026
Først lagt ut (Faktiske)
13. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- CAHSS2601/02
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .