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Mind Body Balance for Pediatric Migraine

Active, not recruitingNot applicableNCT04715685
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Mind Body Balance for Pediatric Migraine
Conditions
Interventions
  • Behavioral: 40 minute session
  • Behavioral: 20 minute session
  • Behavioral: home practice e-health
  • Behavioral: home practice handout
  • Behavioral: phone call
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Start date
2021-03-09
Primary completion
2026-11-01
Sex
All
Age range
from 10 Years to 17 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
2

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Diagnosis: Migraine with or without aura or chronic migraine that meets the International Classification of Headache Disorders(ICHD) criteria * Frequency: Headache frequency based upon prospective headache diary of 28 days must be ≥ 4 and ≤ 28. * PedMIDAS: PedMIDAS Disability Score \> 4, indicating at least mild disruption in daily activities and \< 140, indicating extreme disability that may require more comprehensive, multi-component therapy * Use of one or more of the following prescribed nutraceuticals and/or preventive anti-migraine medications at the time or randomization or be on a stable dose of one or more of the following throughout the 12 weeks of the study \[Vitamin B2 (Riboflavin), Co-Q 10 (Coenzyme Q10), Magnesium (Mg), Vitamin D2 or D3 (Erocalciferol/Cholecalciferol), Depakote (Divalproate), Inderal (Propanerol), Elavil ((Amitripyline), Topamax (Topiramate), Periactin (Cyproheptadine)\] * Language: English speaking, able to complete interviews and questionnaires in English Exclusion Criteria: * Continuous migraine defined as unrelenting headache for a 28 day period * Must agree not to take non-specific acute medication, such as NSAIDS (e.g., ibuprofen), more than 3 times per week, or migraine specific acute medications, such as triptans, more than 6 times per month (to prevent medication overuse headache) * PedMIDAS Disability Score \> 140, indicating extreme disability that may require more comprehensive, multi-component therapy * Youth who are pregnant, or those who are sexually active and not using a medically accepted form of contraception (barrier or hormonal methods) * Present severe psychiatric disease, alcohol or drug dependence, or documented developmental delays or impairments (e.g., autism, cerebral palsy, or mental retardation) or other circumstances, that, in the opinion of the investigator, would interfere with adherence to study requirements or safe participation in the study

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04715685