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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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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

Studietyp

Interventionell

Inskrivning (Beräknad)

130

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

    • Alaska
      • Anchorage, Alaska, Förenta staterna, 99505
        • Rekrytering
        • Joint Base Elmendorf-Richardson (JBER)
        • Kontakt:
        • Huvudutredare:
          • Earl J Banning, PsyD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Nej

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Andra namn:
  • Group Music Therapy
Inget ingripande: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Pain Intensity
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Pain Medication Use
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Post-Traumatic Stress Symptoms (Moderator)
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

17 mars 2026

Primärt slutförande (Beräknad)

1 juli 2028

Avslutad studie (Beräknad)

1 december 2028

Studieregistreringsdatum

Först inskickad

5 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

5 augusti 2026

Första postat (Faktisk)

10 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

27 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

25 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • HU00012420072

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

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Nej

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