About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Patient-Directed Music Therapy (PDMT)
Other interventionMusic 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 and Matched Interaction
Other interventionEnvironmental 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.
Treatment groups
Trial outcomes
Primary outcomes
Improvement in Anxiety Severity
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 。
Secondary outcomes
Pain Severity
Assessed using the Critical-Care Pain Observation Tool (CPOT)
Sleep Quality
Measured by the Pittsburgh Sleep Quality Index (PSQI)
Successful Extubation Rate
The percentage of patients who successfully remain extubated for at least 48 hours without requiring re-intubation
Sponsors and contacts
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