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

NCT07560384 | Not Yet Recruiting

• 1 other identifier: 2026bkky-051
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prolonged Mechanical Ventilation; Anxiety

Keywords

Music Therapy; Prolonged Mechanical Ventilation; Anxiety; Intensive Care Unit; Patient-Directed Music Intervention

Outcome Measures

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 。

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

Secondary Outcomes (3)

• Pain Severity

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

• Sleep Quality

  Baseline (T0) and Day 14 (T3)

• Successful Extubation Rate

  Up to Day 14 or discharge from ICU

Study Arms (2)

Experimental: Music Therapy Group

EXPERIMENTAL

Participants will receive patient-directed music therapy (PDMT) in addition to standard respiratory ICU/rehabilitation care and environmental control.

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

Active Comparator: Control Group

ACTIVE COMPARATOR

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.

Other: Environmental Control and Matched Interaction

Interventions

Patient-Directed Music Therapy (PDMT) OTHER

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.

Experimental: Music Therapy Group

Environmental Control and Matched Interaction OTHER

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.

Active Comparator: Control Group; Experimental: Music Therapy Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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).
• 、Voluntarily signed the informed consent form (either by the patient or their legal representative).

You may not qualify if:

• 、Cognitive or psychiatric disorders: history of severe mental illness (e.g., schizophrenia, severe depression, bipolar disorder) or diagnosed moderate-to-severe dementia/cognitive impairment.
• 、Presence of delirium: assessed as positive by the Confusion Assessment Method for the ICU (CAM-ICU) prior to enrollment.
• 、Extreme hemodynamic instability: unstable vital signs requiring frequent resuscitation, or in the acute phase of a severe cardio-cerebrovascular accident.
• 、Untreated hearing impairment. 5、Physical conditions preventing safe earphone use (e.g., skin damage, burns, facial or cranial fractures).
• 、Poor prognosis: end-stage disease or assessed by the investigator as having a life expectancy insufficient to complete the intervention and follow-up period.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Beijing Rehabilitation Hospital, Capital Medical University

Beijing, Beijing Municipality, 100144, China

Location

Related Publications (3)

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• 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.

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MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Hongying Jiang

  Beijing Rehabilitation Hospital

  STUDY DIRECTOR

Central Study Contacts

Songqi Shi, Bachelor of Science

CONTACT

+86-18601258786; 1499913759@qq.com

Hongying Jiang, Ph.D.

CONTACT

+86-10-56981067

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is a single-blind study. Due to the sensory nature of the intervention (listening to music), participants and bedside care providers cannot be masked. To minimize assessment bias, the outcomes assessors and statisticians who analyze the primary outcomes (e.g., VAS-A, STAI-S scores) will be kept blinded to the group assignments throughout the study period.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Therapist

Model Details: This is a multi-center, single-blind, randomized controlled trial with a parallel-group design. A total of 200 participants will be randomly assigned to either the experimental group or the control group using a 1:1 allocation ratio. The experimental group will receive patient-directed music therapy (30 minutes, twice daily) in addition to standard ICU/rehabilitation care for 14 days. The control group will receive standard care and environmental control (noise and light management).

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 1, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)