Effects of Music Therapy on Anxiety Symptoms in Patients With Prolonged Mechanical Ventilation: A Randomized Controlled Trial
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.
연구 개요
상태
정황
상세 설명
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).
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Songqi Shi, Bachelor of Science
- 전화번호: +86-18601258786
- 이메일: 1499913759@qq.com
연구 연락처 백업
- 이름: Hongying Jiang, Ph.D.
- 전화번호: +86-10-56981067
연구 장소
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Beijing Municipality
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Beijing, Beijing Municipality, 중국, 100144
- Beijing Rehabilitation Hospital, Capital Medical University
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연락하다:
- Songqi Shi, Bachelor of Science
- 전화번호: +86-18601258786
- 이메일: 1499913759@qq.com
-
연락하다:
- Hongying Jiang, Ph.D.
- 전화번호: +86-10-56981067
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Experimental: Music Therapy Group
Participants will receive patient-directed music therapy (PDMT) in addition to standard respiratory ICU/rehabilitation care and environmental control.
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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: 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. |
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활성 비교기: Active Comparator: Control Group
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.
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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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Improvement in Anxiety Severity
기간: Change from Baseline (T0) to Day 14 of intervention (T3)
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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 。
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Change from Baseline (T0) to Day 14 of intervention (T3)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain Severity
기간: Baseline (T0), Day 3 (T1), Day 7 (T2), and Day 14 (T3)
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Assessed using the Critical-Care Pain Observation Tool (CPOT)
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Baseline (T0), Day 3 (T1), Day 7 (T2), and Day 14 (T3)
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Sleep Quality
기간: Baseline (T0) and Day 14 (T3)
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Measured by the Pittsburgh Sleep Quality Index (PSQI)
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Baseline (T0) and Day 14 (T3)
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Successful Extubation Rate
기간: Up to Day 14 or discharge from ICU
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The percentage of patients who successfully remain extubated for at least 48 hours without requiring re-intubation
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Up to Day 14 or discharge from ICU
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공동 작업자 및 조사자
수사관
- 연구 책임자: Hongying Jiang, Beijing Rehabilitation Hospital
간행물 및 유용한 링크
일반 간행물
- Gerber JS, Prasad PA, Fiks AG, Localio AR, Grundmeier RW, Bell LM, Wasserman RC, Keren R, Zaoutis TE. Effect of an outpatient antimicrobial stewardship intervention on broad-spectrum antibiotic prescribing by primary care pediatricians: a randomized trial. JAMA. 2013 Jun 12;309(22):2345-52. doi: 10.1001/jama.2013.6287.
- Schilling G. Space science. Europe trumpets successes on Mars and Titan. Science. 2005 Dec 9;310(5754):1598. doi: 10.1126/science.310.5754.1598. No abstract available.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2026bkky-051
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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Patient-Directed Music Therapy (PDMT)에 대한 임상 시험
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The First Affiliated Hospital with Nanjing Medical...West China Hospital; Fujian Medical University Union Hospital; Chinese Academy of Medical... 그리고 다른 협력자들모집하지 않고 적극적으로