Measuring the Effects of Music-Listening On Distress After Intensive Care (MELODIC)
11 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
9
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Joanna Rickman, MSc, BSc
- Numéro de téléphone: 0131 651 3969
- E-mail: J.B.Rickman@sms.ed.ac.uk
Lieux d'étude
-
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Fife
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Kirkcaldy, Fife, Royaume-Uni, KY2 5AH
- Recrutement
- NHS Fife
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Contact:
- Joanna Rickman, MSc, BSc
- Numéro de téléphone: 0131 651 3969
- E-mail: J.B.Rickman@sms.ed.ac.uk
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La 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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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.
|
|
Comparateur actif: 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.
|
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in daily distress scores measured on the visual analogue scale 'Distress Thermometer'
Délai: 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.
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Daily from enrolment to the end of the follow-up phase (5-6 weeks depending on baseline allocation).
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Changes in severity of post-traumatic stress symptoms as measured by the Impact of Events Scale-Revised (IES-R).
Délai: 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).
|
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Changes in anxiety symptom severity as measured by the Generalised Anxiety Disorder (GAD-7) scale.
Délai: 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.
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Baseline, post-intervention (3-4 weeks depending on baseline allocation), and post-follow up (5-6 weeks depending on baseline allocation).
|
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Changes in depression symptom severity as measured by the Patient Health Questionnaire (PHQ-9).
Délai: 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.
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Baseline, post-intervention (3-4 weeks depending on baseline allocation), and post-follow up (5-6 weeks depending on baseline allocation).
|
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Changes in Health-Related Quality of Life (EQ-5D-5L) scores.
Délai: 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).
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Baseline, post-intervention (3-4 weeks depending on baseline allocation), and post-follow up (5-6 weeks depending on baseline allocation).
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Satu Baylan, DClinPsy, PhD, BSc, University of Edinburgh
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
14 août 2026
Achèvement primaire (Estimé)
1 janvier 2027
Achèvement de l'étude (Estimé)
1 mai 2027
Dates d'inscription aux études
Première soumission
3 août 2026
Première soumission répondant aux critères de contrôle qualité
7 août 2026
Première publication (Réel)
13 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
16 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- CAHSS2601/02
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
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Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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