Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440876
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-28
Brief Title:
Music and Imagery for Veterans With Migraine Headache
Sponsor:
Richard L Roudebush VA Medical Center
Organization:
Richard L Roudebush VA Medical Center
Study Overview
Official Title:
Interactive Music And Guided Imagery for Nonpharma Headache Ease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMAGINE
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None