- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Geschat)
Fase
- Fase 2
Contacten en locaties
Studiecontact
- Naam: Joke Bradt, PhD
- Telefoonnummer: 2673595508
- E-mail: jbradt@drexel.edu
Studie Locaties
-
-
Alaska
-
Anchorage, Alaska, Verenigde Staten, 99505
- Werving
- Joint Base Elmendorf-Richardson (JBER)
-
Contact:
- Earl J Banning, PsyD
- Telefoonnummer: 9075800014
- E-mail: earl.j.banning.mil@health.mil
-
Hoofdonderzoeker:
- Earl J Banning, PsyD
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
Andere namen:
|
|
Geen tussenkomst: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Pain Intensity
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Pain Medication Use
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Post-Traumatic Stress Symptoms (Moderator)
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Paul Pasquina, MD, Uniformed Services University of the Health Sciences
- Hoofdonderzoeker: Joke Bradt, PhD, Drexel University
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HU00012420072
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .