Mind Body Balance for Pediatric Migraine

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.

Conditions

• Headache
• Headache Disorders
• Headache, Migraine
• Migraine
• Migraine Disorders
• Migraine With Aura
• Migraine Without Aura
• Chronic Migraine

Interventions

BEHAVIORAL

home 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.

BEHAVIORAL

40 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.

BEHAVIORAL

20 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.

BEHAVIORAL

home practice handout

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

BEHAVIORAL

phone 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.

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH)

  collaborator NIH

• Children's Hospital Medical Center, Cincinnati

  lead OTHER

Principal Investigators

• Scott Powers, PhD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

10 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-09

Primary Completion

2026-05-01

Completion

2026-05-31

Countries

• United States

Study Locations