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- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
Contacts et emplacements
Coordonnées de l'étude
- Nom: Joke Bradt, PhD
- Numéro de téléphone: 2673595508
- E-mail: jbradt@drexel.edu
Lieux d'étude
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Alaska
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Anchorage, Alaska, États-Unis, 99505
- Recrutement
- Joint Base Elmendorf-Richardson (JBER)
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Contact:
- Earl J Banning, PsyD
- Numéro de téléphone: 9075800014
- E-mail: earl.j.banning.mil@health.mil
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Chercheur principal:
- Earl J Banning, PsyD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
Autres noms:
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Aucune intervention: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pain Intensity
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pain Medication Use
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Post-Traumatic Stress Symptoms (Moderator)
Délai: 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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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Paul Pasquina, MD, Uniformed Services University of the Health Sciences
- Chercheur principal: Joke Bradt, PhD, Drexel University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HU00012420072
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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