Mind Body Balance for Pediatric Migraine
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.
| Condition(s) | Headache, Headache Disorders, Headache, Migraine, Migraine, Migraine Disorders, Migraine With Aura, Migraine Without Aura, Chronic Migraine |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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/Ch |
| Ages | 10 Years to 17 Years |
| Sex | All |
| Lead sponsor | Children's Hospital Medical Center, Cincinnati |
| Locations | Aurora, Colorado, United States; Cincinnati, Ohio, United States |
| Start date | 2021-03-09 |
| NCT ID | NCT04715685 |
| Official listing | https://clinicaltrials.gov/study/NCT04715685 |