RecruitingNot ApplicableNCT04715685

Mind Body Balance for Pediatric Migraine


Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

260 participants

Start Date

Mar 9, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This study uses a factorial research design to evaluate a nurse delivered mind body intervention using different doses of 3 treatment components to determine the optimized treatment for headache day reduction.


Eligibility

Min Age: 10 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called 20 minute session, a behavioral approach called 40 minute session, and others for people with chronic migraine, headache, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 10 Years to 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORAL40 minute session

The 40 minute session will include all of the content contained in the 20 minute session, but will include a greater explanation of each of the mind and body skills, followed by in vivo practice of each skill with the nurse. Sessions will also include review of home practice for each group.

BEHAVIORAL20 minute session

For participants randomized to the 20 minute session, content will include pain education, followed by brief explanations of each of the mind and body skills, in vivo diaphragmatic breathing practice and demonstration of use of biofeedback card. Sessions will also include review of home practice for each group.

BEHAVIORALhome practice e-health

Participants will be provided and instructed on access to a migraine-specific interactive web portal, Migraine e-Health. This web-based tool actively guides participants in practicing evidence-based mind and body skills. Use of the Migraine -e-Health application for the high dose capitalizes on teaching participants mind and body skills while increasing accessibility due to implementation on mobile devices.

BEHAVIORALhome practice handout

Participants will be given a handout of commercially available free apps relevant to the mind body skills introduced.

BEHAVIORALphone call

The dose of phone call will occur about 4 weeks following the face-to-face mind and body introduction session and will last approximately 5-10 minutes. The phone call will be used to promote adherence to home-practice and answer questions related to skill use/home practice completion.


Locations(2)

University of Colorado/Children's Hospital Colorado

Aurora, Colorado, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

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NCT04715685


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