Actively Recruiting

Phase Not Applicable
Age: 10Years - 17Years
All Genders
NCT04715685

Mind Body Balance for Pediatric Migraine

Led by Children's Hospital Medical Center, Cincinnati · Updated on 2026-03-18

260

Participants Needed

2

Research Sites

272 weeks

Total Duration

On this page

Sponsors

C

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

N

National Center for Complementary and Integrative Health (NCCIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Mind Body Balance for Pediatric Migraine

Who Can Participate

Age: 10Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of migraine with or without aura or chronic migraine meeting International Classification of Headache Disorders criteria
  • Headache frequency between 4 and 28 days during a 28-day prospective diary period
  • PedMIDAS disability score greater than 4 and less than 140
  • Use or stable dose of prescribed nutraceuticals or preventive anti-migraine medications including Vitamin B2, Coenzyme Q10, Magnesium, Vitamin D2 or D3, Depakote, Inderal, Elavil, Topamax, or Periactin
  • English speaking and able to complete interviews and questionnaires in English
Not Eligible

You will not qualify if you...

  • Continuous migraine with unrelenting headache for 28 days
  • Use of non-specific acute medication more than 3 times per week or migraine-specific acute medication more than 6 times per month
  • PedMIDAS disability score greater than 140
  • Pregnant or sexually active without using medically accepted contraception
  • Severe psychiatric disease, alcohol or drug dependence, or documented developmental delays or impairments that interfere with study participation or safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

University of Colorado/Children's Hospital Colorado

Aurora, Colorado, United States, 80045

Active, Not Recruiting

2

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Actively Recruiting

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Research Team

L

LeighAnn Chamberlin, MEd

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

8

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