Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT06440876

Music and Imagery for Veterans With Migraine Headache

Interactive Music And Guided Imagery for Nonpharma Headache Ease

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
25 (estimated)
Sponsor
Richard L. Roudebush VA Medical Center · Federal
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to determine feasibility and acceptability of telehealth music imagery for migraine (Aim 1) and to explore whether there are clinically meaningful changes in headache frequency and associated patient-centered outcomes (Aim 2).

Detailed description

IMAGINE is a single arm pilot trial. At least 10 and up to 25 Veterans with migraine headache will participate in 8-weekly one-to-one telehealth MI sessions. Sessions will be conducted via a private channel in VA Microsoft Teams, which is a VA approved platform. Each 60-minute MI session is facilitated by a music therapist and consists of 1) a verbal check-in 2) music listening (Veteran patient and therapist choose music together) 3) processing imagery elicited by music, which is done through optional artwork or discussion of the imagery 4) identification of ways to continue to work with music and imagery independently between sessions. Feasibility metrics related to recruitment, retention, engagement, and completion of treatment protocols and assessments will be evaluated. Acceptability will be measured through brief feedback from participant interviews. Qualitative interviews will be conducted to attain Veteran experiences, including perceived benefits, barriers and facilitators. Interview transcripts will be coded and analyzed for emergent themes. Aim 2 outcomes will be explored through changes in headache frequency and associated symptoms from baseline to follow-up immediately following completion of MI sessions. Descriptive statistics will be used to report outcomes. This study is not powered to detect differences in outcomes.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMusic and ImagerySee music and imagery arm description.

Timeline

Start date
2024-06-15
Primary completion
2025-06-15
Completion
2025-08-15
First posted
2024-06-04
Last updated
2024-06-04

Source: ClinicalTrials.gov record NCT06440876. Inclusion in this directory is not an endorsement.