Feasibility and Acceptability of Music Therapy for Chronic Pain

NCT ID: NCT05426941

Last Updated: 2022-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2023-09-30

Brief Summary

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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

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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

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Music Imagery

MI sessions will be delivered by board-certified music therapists with specialized training in MI and the study treatment protocol.The 8-session protocol has two stages. Stage 1 (sessions 1-4) is focused on learning to use music and imagery for self-regulation. Once the Veteran has demonstrated skill in using music for self-regulation, Stage 2 (sessions 5-8) shifts to identify and deepen their inner resources and how they can use those resources for self-care.

Group Type EXPERIMENTAL

Music Imagery

Intervention Type BEHAVIORAL

Up to 30 participants will be randomized to receive 8 weekly Music Imagery sessions over 8-12 weeks.

Music Listening

Following a one-time meeting with a music therapist, an electronic playlist will be compiled for the Veteran to listen to during the 12-week treatment period.

Group Type EXPERIMENTAL

Music Listening

Intervention Type BEHAVIORAL

Up to 15 participants will be randomized to independent music listening.

Usual care

Participants in the usual care arm (as is the case for MI and ML groups) may receive analgesics and non-pharmacological treatments (e.g., physical therapy) for their chronic musculoskeletal pain.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Music Imagery

Up to 30 participants will be randomized to receive 8 weekly Music Imagery sessions over 8-12 weeks.

Intervention Type BEHAVIORAL

Music Listening

Up to 15 participants will be randomized to independent music listening.

Intervention Type BEHAVIORAL

Other Intervention Names

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music therapy music therapy

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA Office of Research and Development

FED

Sponsor Role collaborator

Indiana Institute for Medical Research

OTHER

Sponsor Role collaborator

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Bair

Role: PRINCIPAL_INVESTIGATOR

Roudebush VA Medical Center

Maya Story

Role: PRINCIPAL_INVESTIGATOR

Roudebush VA Medical Center

Locations

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Roudebush VA Medical Center

Indianapolis, Indiana, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Barry Barker

Role: CONTACT

317-988-4312

Matthew Bair

Role: CONTACT

317-988-2058

Facility Contacts

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Barry Barker

Role: primary

317-988-4312

Matthew Bair

Role: backup

317-988-2058

References

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Story KM, Wasmuth S, Belkiewitz JM, Whalen C, Robb SL, Bravata DM, Bair MJ. Military veterans' perspectives on using music to manage chronic pain: themes from the feasibility and acceptability of music imagery and listening interventions for analgesia study. Front Neurol. 2025 Aug 6;16:1613220. doi: 10.3389/fneur.2025.1613220. eCollection 2025.

Reference Type DERIVED
PMID: 40843263 (View on PubMed)

Story KM, Bravata DM, Robb SL, Wasmuth S, Slaven JE, Whitmire L, Barker B, Menen T, Bair MJ. Feasibility and Acceptability of Music Imagery and Listening Interventions for Analgesia: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Sep 22;11(9):e38788. doi: 10.2196/38788.

Reference Type DERIVED
PMID: 36136377 (View on PubMed)

Other Identifiers

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1863501-22-C-20

Identifier Type: -

Identifier Source: org_study_id

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