Effects of Music Therapy on Anxiety Symptoms in Patients With Prolonged Mechanical Ventilation: A Randomized Controlled Trial
The purpose of this study is to evaluate the effects of music therapy on anxiety symptoms in patients requiring prolonged mechanical ventilation (PMV). PMV patients, defined as those ventilated for more than 21 days, often experience intense psychological stress and anxiety due to long-term intubation and the ICU environment. High anxiety can lead to "patient-ventilator asynchrony," which delays the weaning process.
In this study, 200 participants will be randomly assigned to either a control group receiving standard care or an experimental group receiving patient-directed music therapy. The music therapy intervention involves listening to selected music through noise-canceling headphones for 30 minutes, twice daily, over a 14-day period. The study will measure improvements in anxiety levels, pain, and sleep quality to determine if music therapy can help break the cycle of anxiety and facilitate recovery.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This is a prospective, single-blind, multi-center randomized controlled trial conducted at Beijing Rehabilitation Hospital and two collaborating medical institutions. Eligible participants are patients aged 50 or older who meet the diagnostic criteria for prolonged mechanical ventilation (ventilation duration ≥ 21 days for at least 6 hours per day).
Intervention Protocols:
Experimental Group: Participants will receive "Patient-Directed" music therapy in addition to standard ICU/rehabilitation care. A digital music library featuring classical, nature sounds, light pop, and traditional Chinese folk music (60-80 bpm) will be used. Music is delivered via medical-grade noise-canceling headphones at a volume of 60-70 decibels for 30 minutes, twice daily (10:00-11:00 and 15:00-16:00), for a total of 14 days.
Control Group: Participants will receive standard care and environmental control (noise and light management). To minimize bias, the interaction time between nursing staff and patients in the control group will be identical to that in the experimental group.
Outcome Measures:
Primary Outcome: Improvement in anxiety severity measured by the Visual Analog Scale for Anxiety (VAS-A) and the State-Trait Anxiety Inventory (STAI-S).
Secondary Outcomes: Pain levels assessed by the Critical-Care Pain Observation Tool (CPOT), sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI), and successful extubation rates.
Statistical Analysis: Data will be analyzed using SPSS 26.0 and R 4.3. Linear Mixed Models (LMM) or Generalized Estimating Equations (GEE) will be employed to evaluate longitudinal changes across four time points: baseline (T0), day 3 (T1), day 7 (T2), and day 14 (T3).
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Songqi Shi, Bachelor of Science
- Número de telefone: +86-18601258786
- E-mail: 1499913759@qq.com
Estude backup de contato
- Nome: Hongying Jiang, Ph.D.
- Número de telefone: +86-10-56981067
Locais de estudo
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100144
- Beijing Rehabilitation Hospital, Capital Medical University
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Contato:
- Songqi Shi, Bachelor of Science
- Número de telefone: +86-18601258786
- E-mail: 1499913759@qq.com
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Contato:
- Hongying Jiang, Ph.D.
- Número de telefone: +86-10-56981067
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- 1、Age > 50 years 2、Diagnosed with Prolonged Mechanical Ventilation (PMV), meeting the following criteria: Continuous mechanical ventilation for ≥ 21 days Daily mechanical ventilation duration ≥ 6 hours Ventilation via endotracheal tube, tracheostomy, or non-invasive interface (face/nasal mask).
3、Voluntarily signed the informed consent form (either by the patient or their legal representative).
Exclusion Criteria:
1、Cognitive or psychiatric disorders: history of severe mental illness (e.g., schizophrenia, severe depression, bipolar disorder) or diagnosed moderate-to-severe dementia/cognitive impairment.
2、Presence of delirium: assessed as positive by the Confusion Assessment Method for the ICU (CAM-ICU) prior to enrollment.
3、Extreme hemodynamic instability: unstable vital signs requiring frequent resuscitation, or in the acute phase of a severe cardio-cerebrovascular accident.
4、Untreated hearing impairment. 5、Physical conditions preventing safe earphone use (e.g., skin damage, burns, facial or cranial fractures).
6、Poor prognosis: end-stage disease or assessed by the investigator as having a life expectancy insufficient to complete the intervention and follow-up period.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Experimental: Music Therapy Group
Participants will receive patient-directed music therapy (PDMT) in addition to standard respiratory ICU/rehabilitation care and environmental control.
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Music Selection: Patients or families select genres (classical, nature sounds, light pop, or traditional Chinese folk) with a tempo of 60-80 bpm. Equipment: Medical-grade noise-canceling headphones. Dosage: 30 minutes per session, twice daily (10:00-11:00 and 15:00-16:00) for 14 consecutive days. Volume: Limited to 60-70 decibels. Environmental Control: Minimizing noise and light interference in the ward, using silent earplugs and eyemasks when necessary. Matched Interaction: Nursing staff will spend the same amount of bedside time with control group patients as they do with the music therapy group to ensure consistency in care-related interaction. |
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Comparador Ativo: Active Comparator: Control Group
Participants will receive standard respiratory ICU/rehabilitation care, including routine analgesia/sedation management, mechanical ventilation adjustment, and basic psychological support.
They will also receive environmental control (noise and light management) and matched nurse bedside interaction time to control for the Hawthorne effect.
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Environmental Control: Minimizing noise and light interference in the ward, using silent earplugs and eyemasks when necessary. Matched Interaction: Nursing staff will spend the same amount of bedside time with control group patients as they do with the music therapy group to ensure consistency in care-related interaction. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Improvement in Anxiety Severity
Prazo: Change from Baseline (T0) to Day 14 of intervention (T3)
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Measured by the Visual Analog Scale for Anxiety (VAS-A) and the State-Trait Anxiety Inventory-State (STAI-S) 。VAS-A is a 0-10 cm scale where higher scores indicate higher anxiety levels.
STAI-S is a 20-item scale assessing current state anxiety 。
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Change from Baseline (T0) to Day 14 of intervention (T3)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pain Severity
Prazo: Baseline (T0), Day 3 (T1), Day 7 (T2), and Day 14 (T3)
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Assessed using the Critical-Care Pain Observation Tool (CPOT)
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Baseline (T0), Day 3 (T1), Day 7 (T2), and Day 14 (T3)
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Sleep Quality
Prazo: Baseline (T0) and Day 14 (T3)
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Measured by the Pittsburgh Sleep Quality Index (PSQI)
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Baseline (T0) and Day 14 (T3)
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Successful Extubation Rate
Prazo: Up to Day 14 or discharge from ICU
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The percentage of patients who successfully remain extubated for at least 48 hours without requiring re-intubation
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Up to Day 14 or discharge from ICU
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Hongying Jiang, Beijing Rehabilitation Hospital
Publicações e links úteis
Publicações Gerais
- Gerber JS, Prasad PA, Fiks AG, Localio AR, Grundmeier RW, Bell LM, Wasserman RC, Keren R, Zaoutis TE. Effect of an outpatient antimicrobial stewardship intervention on broad-spectrum antibiotic prescribing by primary care pediatricians: a randomized trial. JAMA. 2013 Jun 12;309(22):2345-52. doi: 10.1001/jama.2013.6287.
- Schilling G. Space science. Europe trumpets successes on Mars and Titan. Science. 2005 Dec 9;310(5754):1598. doi: 10.1126/science.310.5754.1598. No abstract available.
- Rubin LH, Phan KL, Keating SM, Maki PM. A single low dose of hydrocortisone enhances cognitive functioning in HIV-infected women. AIDS. 2018 Sep 10;32(14):1983-1993. doi: 10.1097/QAD.0000000000001930.
Datas de registro do estudo
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Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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Enviado pela primeira vez que atendeu aos critérios de CQ
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Atualizações de registro de estudo
Última Atualização Postada (Real)
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Mais Informações
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Palavras-chave
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Outros números de identificação do estudo
- 2026bkky-051
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