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

NCT07560384 · tracked via the Priya Life Science China tracker

Sponsor

Capital Medical University

Phase

Not applicable

Started

2026-05

Last updated

2026-05-01

Condition(s) studied

AnxietyProlonged Mechanical Ventilation

Investigational drug(s) / intervention(s)

Patient-Directed Music Therapy (PDMT)Environmental Control and Matched Interaction

Patient-Directed Music Therapy (PDMT): 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: 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.

Study summary

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

Sex

ALL

Min age

50 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Improvement in Anxiety Severity — Change from Baseline (T0) to Day 14 of intervention (T3)
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 。

Trial sites (1)

Facility	City	Region	Status
Beijing Rehabilitation Hospital, Capital Medical University	Beijing	Beijing Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07560384 on ClinicalTrials.gov ↗ ← All trials in China