Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 14, 2022
Date Accepted: Jul 30, 2022
Feasibility and Acceptability of Music Imagery, and Listening Interventions for Analgesia (FAMILIA): Randomized Controlled Trial Protocol
ABSTRACT
Background:
Background:
Chronic pain and access to care are identified as critical needs of the Veterans Health Administration (VHA). Music Imagery (MI) and Music Listening (ML) interventions have shown promise as effective non-pharmacological options for pain management; however, most studies have focused on acute pain, passive music experiences, and in-person delivery.
Objective:
Objective:
To examine the feasibility and acceptability of two music interventions delivered through telehealth for chronic musculoskeletal pain, trial design, and theoretical model before conducting a fully powered efficacy or comparative effectiveness trial.
Methods:
Methods:
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.
Results:
Results:
Potential participants are identified through the VA database. FAMILIA is in the recruitment phase of the study.
Conclusions:
Conclusions:
Aligned with VHA initiatives, FAMILIA addresses four limitations in music intervention research for chronic pain: limited studies in Veterans, evaluation of a multi-component music intervention, methodological rigor, and virtual delivery. Clinical Trial: Trial Registration: ClinicalTrials.gov NCT05426941 https://www.clinicaltrials.gov/ct2/show/NCT05426941?term=Music&recrs=ab&type=Intr&cond=Chronic+Pain&cntry=US&age=1&draw=2&rank=1
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