NCT05426941

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 22, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

July 1, 2022

Status Verified

June 1, 2022

Enrollment Period

2 years

First QC Date

May 25, 2022

Last Update Submit

June 28, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Percentage of contacted and eligible Veterans consent to study participation, attend intervention sessions, and complete the treatment protocol and scheduled outcome assessments?

    Determine the feasibility of the music therapy interventions

    at 3 months

  • Aspects of the interventions do Veterans perceive to be most/least helpful or most/least liked?

    Assess participant acceptability of the music therapy interventions

    at 3 months

Secondary Outcomes (11)

  • Numeric Rating Scale for Pain intensity

    Baseline, 1, 3, and 4 months

  • Brief Pain Inventory - Pain interference subscale

    Baseline, 1, 3, and 4 months

  • Brief Pain Catastrophizing Scale

    Baseline, 1, 3, and 4 months

  • Centrality of Pain Scale

    Baseline, 1, 3, and 4 months

  • Patient Global Impression of Change Scale

    1,3 and 4 months

  • +6 more secondary outcomes

Study Arms (3)

Music Imagery

EXPERIMENTAL

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.

Behavioral: Music Imagery

Music Listening

EXPERIMENTAL

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.

Behavioral: Music Listening

Usual care

NO INTERVENTION

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.

Interventions

Music ImageryBEHAVIORAL

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

Also known as: music therapy
Music Imagery
Music ListeningBEHAVIORAL

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

Also known as: music therapy
Music Listening

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roudebush VA Medical Center

Indianapolis, Indiana, 46202, United States

RECRUITING

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Chronic Pain

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Matthew Bair

    Roudebush VA Medical Center

    PRINCIPAL INVESTIGATOR
  • Maya Story

    Roudebush VA Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2022

First Posted

June 22, 2022

Study Start

September 1, 2021

Primary Completion

August 30, 2023

Study Completion

September 30, 2023

Last Updated

July 1, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations