Chronic Pain
Conditions
Keywords
Chronic Pain, Music Therapy
Brief summary
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.
Detailed description
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
Interventions
BEHAVIORALMusic intervention
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.
Sponsors
Henry M. Jackson Foundation for the Advancement of Military Medicine
Drexel University
Joint Base Elmendorf-Richardson
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Statistician will be masked
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | 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. |
| Pain Interference | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain-related self-efficacy | 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. |
| Depression | 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. |
| Anxiety | 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. |
| Positive Well-Being | 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. |
| Sleep Disturbance | 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. |
| Disability | 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. |
| Patient Perception of Change | 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. |
| Pain Medication Use | Baseline, Week 8, 1-Month Follow-Up | Medication use from participant daily reports for 7 days |
Countries
United States
Contacts
CONTACTJoke Bradt, PhD
PRINCIPAL_INVESTIGATORJoke Bradt, PhD
Drexel University
PRINCIPAL_INVESTIGATORPaul Pasquina, MD
Uniformed Services University of the Health Sciences
Outcome results
None listed