Feasibility and Acceptability of Music Therapy for Chronic Pain (FAMILIA)

  • STATUS
    Recruiting
  • days left to enroll
    3
  • participants needed
    60
  • sponsor
    Henry M. Jackson Foundation for the Advancement of Military Medicine
Updated on 4 October 2022
chronic pain
music therapy
Accepts healthy volunteers

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.

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.

Details
Condition Chronic Pain
Treatment Music Listening, Music Imagery
Clinical Study IdentifierNCT05426941
SponsorHenry M. Jackson Foundation for the Advancement of Military Medicine
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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