- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07755540
Group Music Therapy for Chronic Pain Management in Active Duty Service Members
Group Music Therapy for Chronic Pain Management in Active Duty Service Members With Chronic Pain: A Randomized Controlled Trial
연구 개요
상세 설명
Chronic pain is a significant health concern among military personnel and veterans and is associated with disability and reduced quality of life. Music therapy is a non-pharmacological intervention that may address biological, psychological, and social factors contributing to chronic pain.
This mixed-methods research study embeds qualitative inquiry within a randomized controlled trial. A total of 130 active duty service members with chronic pain will be randomized 1:1 to either an 8-week group music therapy intervention plus standard care or standard care alone. The music therapy intervention consists of eight weekly 75-minute sessions delivered in groups of 6-8 participants and includes music-guided breathing, music-based relaxation exercises, group improvisation, verbal processing, listening to meaningful music, and instruction in music-based pain self-management strategies.
Primary outcomes are pain interference and pain intensity. Secondary outcomes include pain-related self-efficacy, depression, anxiety, positive affect, sleep disturbance, patient global impression of change, disability, and pain medication use. Outcomes will be evaluated at baseline, week 8, and 1-month follow-up. Semi-structured interviews will be conducted with approximately 20 participants from the music therapy arm after follow-up assessment to explore treatment experiences and perceived benefits
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Joke Bradt, PhD
- 전화번호: 2673595508
- 이메일: jbradt@drexel.edu
연구 장소
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Alaska
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Anchorage, Alaska, 미국, 99505
- 모병
- Joint Base Elmendorf-Richardson (JBER)
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연락하다:
- Earl J Banning, PsyD
- 전화번호: 9075800014
- 이메일: earl.j.banning.mil@health.mil
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수석 연구원:
- Earl J Banning, PsyD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Active duty service member
- Age 18 -64 years of age
- Diagnosis of chronic benign pain for at least 3 months
- Average pain severity greater than 4/10 on the Defense and Veterans Pain Rating Scale
- Able to read and understand English
Exclusion Criteria:
- Pregnancy
- Mental health conditions that would prevent compliance with or productive participation in group sessions
- Cognitive impairment preventing completion of study measures
- Malignant disease
- Progressive neurological disorder
- Moderate to profound hearing impairment not corrected with hearing aids
- Previous participation in music therapy services at Joint Base Elmendorf-Richardson (JBER)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Group Music Therapy + Standard Care
Participants will receive eight weekly 75-minute group music therapy sessions in addition to standard pain management care.
Sessions include music-guided breathing, relaxation exercises, group improvisation, music listening, discussion, and music-based pain self-management training.
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An 8-week standardized music therapy protocol delivered in weekly 75-minute group sessions.
The intervention is guided by a biopsychosocial framework and includes music-guided breathing, relaxation exercises, group improvisation, processing of music experiences, meaningful music listening, and home practice of music-based pain management skills.
다른 이름들:
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간섭 없음: Standard Care
Participants will receive standard pain management services available at Joint Base Elmendorf-Richardson.
These may include medication management, physical therapy, acupuncture, cognitive behavioral therapy, and interventional pain procedures.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pain Intensity
기간: Baseline, Week 8, and 1-Month Follow-Up as well as pre and post- session
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As measured by the Defense and Veterans Pain Rating Scale (DVPRS), where each item is scored 0-10 and a higher total score indicates a worse outcome.
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Baseline, Week 8, and 1-Month Follow-Up as well as pre and post- session
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Pain Interference
기간: Baseline, Week 8, and 1-Month Follow-Up
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As measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 8-item Scale, where each item is scored 1-5 and a higher total score indicates a worse outcome.
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Baseline, Week 8, and 1-Month Follow-Up
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain Medication Use
기간: Baseline, Week 8, 1-Month Follow-Up
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Medication use from participant daily reports for 7 days
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Baseline, Week 8, 1-Month Follow-Up
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Pain-related self-efficacy
기간: Baseline, Week 8, 1-Month Follow-Up
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As measured by the 6-item University of Washington Pain Related Self-Efficacy Scale (UWPRSE), where each item is scored 1-5 and a higher total score indicates a better outcome.
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Baseline, Week 8, 1-Month Follow-Up
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Depression
기간: Baseline, Week 8, 1-Month Follow-Up
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As measured by the 9-item Patient Health Questionnaire scale (PHQ-9), where each item is scored 0-3 and a higher total score indicates a worse outcome.
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Baseline, Week 8, 1-Month Follow-Up
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Anxiety
기간: Baseline, Week 8, 1-Month Follow-Up
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As measured by the 7-item Generalized Anxiety Disorder Scale (GAD-7), where each item is scored 0-3 and a higher total score indicates a worse outcome.
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Baseline, Week 8, 1-Month Follow-Up
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Positive Well-Being
기간: Baseline, Week 8, 1-Month Follow-Up
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As measured by the 14-item Warwick-Edinburgh Mental Well-Being Scale (WEMWBS), where each item is scored 1-5 and a higher total score indicates a better outcome.
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Baseline, Week 8, 1-Month Follow-Up
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Sleep Disturbance
기간: Baseline, Week 8, 1-Month Follow-Up
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As measured by the 8-item PROMIS® Sleep Disturbance Short Form-8a, where each item is scored 1-5 and a higher total score indicates a worse outcome.
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Baseline, Week 8, 1-Month Follow-Up
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Disability
기간: Baseline, Week 8, 1-Month Follow-Up
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As measured by the 10-item Oswestry Disability Index (ODI), where each item is scored 0-5 and a higher total score indicates a worse outcome.
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Baseline, Week 8, 1-Month Follow-Up
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Patient Perception of Change
기간: Week 8, 1-Month Follow-Up
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As measured by the Patient Global Impression of Change Scale (PGIC), a single item scale that uses a 1-7 score and a higher score indicates a better outcome.
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Week 8, 1-Month Follow-Up
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Post-Traumatic Stress Symptoms (Moderator)
기간: Baseline
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As measured by the PTSD Checklist for DSM-5 (PCL-5), where each item is scored 0-4 and a higher total score indicates a worse outcome.
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Baseline
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공동 작업자 및 조사자
수사관
- 수석 연구원: Paul Pasquina, MD, Uniformed Services University of the Health Sciences
- 수석 연구원: Joke Bradt, PhD, Drexel University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
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