RECRUITING

Mind Body Balance for Pediatric Migraine

Conditions

Headache Headache Disorders Headache, Migraine Migraine Migraine Disorders Migraine With Aura Migraine Without Aura Chronic Migraine cognitive behavioral therapy pediatrics mind body intervention diaphragmatic breathing progressive muscle relaxation imagery relaxation biofeedback

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Mind Body Balance for Pediatric Migraine

Quick Facts

Study Start:2021-03-09

Study Completion:2025-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04715685

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

LeighAnn Chamberlin, MEd

CONTACT

513-636-9739

leighann.chamberlin@cchmc.org

Principal Investigator

Scott Powers, PhD

PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Study Locations (Sites)

University of Colorado/Children's Hospital Colorado

Aurora, Colorado, 80045

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

Scott Powers, PhD, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-09

Study Completion Date2025-05-31

Study Record Updates

Study Start Date2021-03-09

Study Completion Date2025-05-31

Terms related to this study

Keywords Provided by Researchers

headache
migraine
cognitive behavioral therapy
pediatrics
mind body intervention
diaphragmatic breathing
progressive muscle relaxation
imagery
relaxation
biofeedback

Additional Relevant MeSH Terms

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