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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

This randomized controlled trial will evaluate the effectiveness of an 8-week group music therapy intervention for active duty service members with chronic pain. Participants will be randomized to either a group music therapy intervention plus standard care or standard care alone. Outcomes will be assessed at baseline, post- treatment (8 weeks), and 1-month follow-up. Primary outcomes include pain interference and pain intensity. Secondary outcomes include pain-related self-efficacy, depression, anxiety, positive affect, sleep disturbance, patient perception of change, and pain medication use. Qualitative interviews will be conducted with a subset of participants who receive music therapy to explore subjective experiences and perceived treatment benefits.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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

Tipo de estudio

Intervencionista

Inscripción (Estimado)

130

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Joke Bradt, PhD
  • Número de teléfono: 2673595508
  • Correo electrónico: jbradt@drexel.edu

Ubicaciones de estudio

    • Alaska
      • Anchorage, Alaska, Estados Unidos, 99505
        • Reclutamiento
        • Joint Base Elmendorf-Richardson (JBER)
        • Contacto:
        • Investigador principal:
          • Earl J Banning, PsyD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
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.
Otros nombres:
  • Group Music Therapy
Sin intervención: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Pain Intensity
Periodo de tiempo: Baseline, Week 8, and 1-Month Follow-Up as well as pre and post- session
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.
Baseline, Week 8, and 1-Month Follow-Up as well as pre and post- session
Pain Interference
Periodo de tiempo: Baseline, Week 8, and 1-Month Follow-Up
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.
Baseline, Week 8, and 1-Month Follow-Up

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Pain Medication Use
Periodo de tiempo: Baseline, Week 8, 1-Month Follow-Up
Medication use from participant daily reports for 7 days
Baseline, Week 8, 1-Month Follow-Up
Pain-related self-efficacy
Periodo de tiempo: Baseline, Week 8, 1-Month Follow-Up
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.
Baseline, Week 8, 1-Month Follow-Up
Depression
Periodo de tiempo: Baseline, Week 8, 1-Month Follow-Up
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.
Baseline, Week 8, 1-Month Follow-Up
Anxiety
Periodo de tiempo: Baseline, Week 8, 1-Month Follow-Up
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.
Baseline, Week 8, 1-Month Follow-Up
Positive Well-Being
Periodo de tiempo: Baseline, Week 8, 1-Month Follow-Up
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.
Baseline, Week 8, 1-Month Follow-Up
Sleep Disturbance
Periodo de tiempo: Baseline, Week 8, 1-Month Follow-Up
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.
Baseline, Week 8, 1-Month Follow-Up
Disability
Periodo de tiempo: Baseline, Week 8, 1-Month Follow-Up
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.
Baseline, Week 8, 1-Month Follow-Up
Patient Perception of Change
Periodo de tiempo: Week 8, 1-Month Follow-Up
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.
Week 8, 1-Month Follow-Up

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Post-Traumatic Stress Symptoms (Moderator)
Periodo de tiempo: Baseline
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.
Baseline

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Paul Pasquina, MD, Uniformed Services University of the Health Sciences
  • Investigador principal: Joke Bradt, PhD, Drexel University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

17 de marzo de 2026

Finalización primaria (Estimado)

1 de julio de 2028

Finalización del estudio (Estimado)

1 de diciembre de 2028

Fechas de registro del estudio

Enviado por primera vez

5 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

5 de agosto de 2026

Publicado por primera vez (Actual)

10 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

25 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • HU00012420072

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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