Feasibility and Acceptability of Music Therapy for Chronic Pain

Not Applicable

• Conditions: Chronic Pain

• Registration Number: NCT05426941
• Lead Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

Brief Summary

The purpose of the study is to examine the feasibility and acceptability of two music interventions delivered through telehealth for chronic musculoskeletal pain. This pilot study evaluates outcomes (feasibility, acceptability, pain and associated outcomes) in a single-component, minimally interactive music listening (ML) intervention and a multi-component, more interactive music imagery (MI) intervention.

Detailed Description

FAMILIA is a 3-arm, parallel group, pilot trial. Sixty Veterans will be randomized to one of three conditions: MI, ML, or usual care. Aim 1 is to test the feasibility and acceptability of a multi-component, interactive MI intervention (8-weekly, individual sessions) and a single-component, minimally interactive ML intervention (independent music listening). Feasibility metrics related to recruitment, retention, engagement, and completion of treatment protocol and questionnaires will be assessed. Up to 20 qualitative interviews will be conducted to assess Veteran experiences with both interventions, including perceived benefits, acceptability, barriers, and facilitators. Interview transcripts will be coded and analyzed for emergent themes. Aim 2 is to explore the effects of MI and ML versus usual care on pain and associated patient-centered outcomes. These outcomes and potential mediators will be explored through changes from baseline to follow-up assessments at 1, 3, and 4 months. Descriptive statistics will be used to describe outcomes; this pilot study is not powered to detect differences in outcomes.

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2022-05-25
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-16
• Study First Posted: 2022-06-22
• Last Update Submitted: 2022-06-28
• Last Update Posted: 2022-07-01
• Primary Completion: 2023-08-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Chronic (> 6 months) musculoskeletal pain of at least moderate severity (≥5 on 0-10 numeric scale)
• Access to a personal computer, tablet computer, and/or smartphone,
• Ability to pass technology assessment screen, and
• Not currently receiving music therapy services

Exclusion Criteria

• Serious or unstable medical (e.g., Congestive Heart Failure, Chronic Obstructive Pulmonary Disease) or psychiatric illness (e.g., psychosis, mania) or housing insecurity that could compromise study participation,
• Suicidal ideation with current intent/plan,
• Hearing or cognitive impairment that may interfere with music listening or abstract thinking needed for imagery work,
• Lack access to a personal computer, tablet computer, and/or smartphone,
• Unable to pass technology assessment screen, or
• Currently receiving music therapy services.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of contacted and eligible Veterans consent to study participation, attend intervention sessions, and complete the treatment protocol and scheduled outcome assessments?	at 3 months	Determine the feasibility of the music therapy interventions
Aspects of the interventions do Veterans perceive to be most/least helpful or most/least liked?	at 3 months	Assess participant acceptability of the music therapy interventions

Secondary Outcome Measures

Name	Time	Method
Numeric Rating Scale for Pain intensity	Baseline, 1, 3, and 4 months	assessment of severity of pain, scored 0 to 10 with higher scores representing more intense pain
Patient Global Impression of Change Scale	1,3 and 4 months	assessment of treatment response, scored 1 to 7 with higher scores representing greater improvement from starting the intervention
PROMIS Sleep Scale	Baseline, 1, 3, and 4 months	assessment of sleep quality, scored 1 to 5 with higher scores representing worse sleep quality (worse outcome)
EQ 5D Scale for Health-Related Quality of Life	Baseline and 3 months	assessment of generic health-related quality of life, scored 0 to 100 with higher scores represent improved quality of life (better outcome)
PHQ-9 Depression Measure	Baseline, 1, 3, and 4 months	assessment of depression severity, scored 0 to 27 with higher scores representing more severe depression (worse outcome)
GAD-7 Anxiety Measure	Baseline, 1, 3, and 4 months	assessment of anxiety severity, scored 0 to 21 with higher scores representing more severe anxiety (worse outcome)
Perceived Stress Scale	Baseline and 3 months	assessment of stress severity, scored 0 to 14 with higher scores representing more severe stress (worse outcome)
Brief Pain Inventory - Pain interference subscale	Baseline, 1, 3, and 4 months	how does pain interfere with 7 activities, scored 0 to 10 with higher scores representing more interference of pain with activities
Brief Pain Catastrophizing Scale	Baseline, 1, 3, and 4 months	assessment of pain belief, scored 0 to 12 with higher scores representing more pain catastrophizing (worse outcome)
Centrality of Pain Scale	Baseline, 1, 3, and 4 months	assessment of pain coping, scored 10 to 50 with higher scores representing the belief that pain is central to individual's life (worse outcome)

Trial Locations

Locations (1)

Roudebush VA Medical Center; 🇺🇸 Indianapolis, Indiana, United States