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

N/ANot Yet RecruitingNCT07560384

Capital Medical University200 enrolled

Overview

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.

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).

Study Type

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.

Environmental Control and Matched InteractionOTHER

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.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

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 。

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

Secondary Outcomes

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)

Sleep Quality

Measured by the Pittsburgh Sleep Quality Index (PSQI)

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

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