Anxiety, Prolonged Mechanical Ventilation
Conditions
Keywords
Music Therapy, Prolonged Mechanical Ventilation, Anxiety, Intensive Care Unit, Patient-Directed Music Intervention
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.
Detailed description
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).
Interventions
OTHERPatient-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.
OTHEREnvironmental 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.
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 。 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Severity | Baseline (T0), Day 3 (T1), Day 7 (T2), and Day 14 (T3) | Assessed using the Critical-Care Pain Observation Tool (CPOT) |
| Sleep Quality | Baseline (T0) and Day 14 (T3) | Measured by the Pittsburgh Sleep Quality Index (PSQI) |
| Successful Extubation Rate | Up to Day 14 or discharge from ICU | The percentage of patients who successfully remain extubated for at least 48 hours without requiring re-intubation |
Countries
China
Contacts
CONTACTSongqi Shi, Bachelor of Science
CONTACTHongying Jiang, Ph.D.
STUDY_DIRECTORHongying Jiang
Beijing Rehabilitation Hospital
Outcome results
None listed