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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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Studietype

Intervensjonell

Registrering (Antatt)

130

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

    • Alaska
      • Anchorage, Alaska, Forente stater, 99505
        • Rekruttering
        • Joint Base Elmendorf-Richardson (JBER)
        • Ta kontakt med:
        • Hovedetterforsker:
          • Earl J Banning, PsyD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Andre navn:
  • Group Music Therapy
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pain Intensity
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pain Medication Use
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Post-Traumatic Stress Symptoms (Moderator)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

17. mars 2026

Primær fullføring (Antatt)

1. juli 2028

Studiet fullført (Antatt)

1. desember 2028

Datoer for studieregistrering

Først innsendt

5. august 2026

Først innsendt som oppfylte QC-kriteriene

5. august 2026

Først lagt ut (Faktiske)

10. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • HU00012420072

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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