- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
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
Inskrivning (Beräknad)
Fas
- Fas 2
Kontakter och platser
Studiekontakt
- Namn: Joke Bradt, PhD
- Telefonnummer: 2673595508
- E-post: jbradt@drexel.edu
Studieorter
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Alaska
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Anchorage, Alaska, Förenta staterna, 99505
- Rekrytering
- Joint Base Elmendorf-Richardson (JBER)
-
Kontakt:
- Earl J Banning, PsyD
- Telefonnummer: 9075800014
- E-post: earl.j.banning.mil@health.mil
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Huvudutredare:
- Earl J Banning, PsyD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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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:
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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.
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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
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.
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Baseline, Week 8, and 1-Month Follow-Up
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pain Medication Use
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Post-Traumatic Stress Symptoms (Moderator)
Tidsram: 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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Samarbetspartners och utredare
Utredare
- Huvudutredare: Paul Pasquina, MD, Uniformed Services University of the Health Sciences
- Huvudutredare: Joke Bradt, PhD, Drexel University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HU00012420072
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