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

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).

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.