NCT05426941

Feasibility and Acceptability of Music Therapy for Chronic Pain

Feasibility and Acceptability of Music Imagery, and Listening Interventions for Analgesia (FAMILIA)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
BEHAVIORAL	Music Imagery	Up to 30 participants will be randomized to receive 8 weekly Music Imagery sessions over 8-12 weeks.
BEHAVIORAL	Music Listening	Up to 15 participants will be randomized to independent music listening.

Timeline

• Start date: 2021-09-01
• Primary completion: 2023-08-30
• Completion: 2023-09-30
• First posted: 2022-06-22
• Last updated: 2022-07-01

Locations

1 site across 1 country: United States