Measuring the Effects of Music-Listening On Distress After Intensive Care (MELODIC)
11 de setembro de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
9
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Joanna Rickman, MSc, BSc
- Número de telefone: 0131 651 3969
- E-mail: J.B.Rickman@sms.ed.ac.uk
Locais de estudo
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Fife
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Kirkcaldy, Fife, Reino Unido, KY2 5AH
- Recrutamento
- NHS Fife
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Contato:
- Joanna Rickman, MSc, BSc
- Número de telefone: 0131 651 3969
- E-mail: J.B.Rickman@sms.ed.ac.uk
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: 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.
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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.
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Comparador Ativo: 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.
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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.
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Comparador Ativo: 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.
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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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in daily distress scores measured on the visual analogue scale 'Distress Thermometer'
Prazo: Daily from enrolment to the end of the follow-up phase (5-6 weeks depending on baseline allocation).
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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).
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Changes in severity of post-traumatic stress symptoms as measured by the Impact of Events Scale-Revised (IES-R).
Prazo: 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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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).
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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 anxiety symptom severity as measured by the Generalised Anxiety Disorder (GAD-7) scale.
Prazo: 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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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).
Prazo: 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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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.
Prazo: 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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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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Satu Baylan, DClinPsy, PhD, BSc, University of Edinburgh
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
14 de agosto de 2026
Conclusão Primária (Estimado)
1 de janeiro de 2027
Conclusão do estudo (Estimado)
1 de maio de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
3 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de agosto de 2026
Primeira postagem (Real)
13 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
16 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- CAHSS2601/02
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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