Effects of Music Therapy on Anxiety Symptoms in Patients With Prolonged Mechanical Ventilation: A Randomized Controlled Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorCapital Medical University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Patient-Directed Music Therapy (PDMT)

    Other intervention

    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 and Matched Interaction

    Other intervention

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Experimental: Music Therapy GroupExperimental treatment 2 interventions
Group B: Active Comparator: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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 。

Time frame
Change from Baseline (T0) to Day 14 of intervention (T3)

Secondary outcomes

1

Pain Severity

Assessed using the Critical-Care Pain Observation Tool (CPOT)

Time frame
Baseline (T0), Day 3 (T1), Day 7 (T2), and Day 14 (T3)
2

Sleep Quality

Measured by the Pittsburgh Sleep Quality Index (PSQI)

Time frame
Baseline (T0) and Day 14 (T3)
3

Successful Extubation Rate

The percentage of patients who successfully remain extubated for at least 48 hours without requiring re-intubation

Time frame
Up to Day 14 or discharge from ICU

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: