[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100417438":3},{"organization":4,"armGroups":7,"interventions":46,"overallOfficials":69,"centralContacts":73,"locations":79,"responsibleParty":110,"collaborators":112,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":52,"eligibilityCriteria":121,"healthyVolunteers":118,"sex":122,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":52,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":141,"overallStatus":96,"whyStopped":52,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},{"fullName":5,"class":6},"Children's Hospital Medical Center, Cincinnati","OTHER",[8,16,20,25,29,34,38,42],{"label":9,"type":10,"description":11,"interventionNames":12},"40 minute session, home practice e-health, phone call","EXPERIMENTAL","This intervention arm consists of mind body skill introduction session that is 40 minutes in duration. The daily home practice component for headache management will utilize a migraine specific interactive web portal, Migraine e-health portal. This arm will also receive a follow up phone call 4 weeks after the introductory session to promote adherence to home practice.",[13,14,15],"Behavioral: 40 minute session","Behavioral: home practice e-health","Behavioral: phone call",{"label":17,"type":10,"description":18,"interventionNames":19},"40 minute session, home practice e-health, no phone call","This intervention arm consists of mind body skill introduction session that is 40 minutes in duration. The daily home practice component for headache management will utilize a migraine specific interactive web portal, Migraine e-health portal. This arm will not receive a follow up phone call 4 weeks after the introductory session to promote adherence to home practice.",[13,14],{"label":21,"type":10,"description":22,"interventionNames":23},"40 minute session, home practice handout, phone call","This intervention arm consists of mind body skill introduction session that is 40 minutes in duration. The daily home practice component for headache management will utilize a handout with explanations of mind body skills and a home practice plan. This arm will also receive a follow up phone call 4 weeks after the introductory session to promote adherence to home practice.",[13,24,15],"Behavioral: home practice handout",{"label":26,"type":10,"description":27,"interventionNames":28},"40 minute session, home practice handout, no phone call","This intervention arm consists of mind body skill introduction session that is 40 minutes in duration. The daily home practice component for headache management will utilize a handout with explanations of mind body skills and a home practice plan. This arm will not receive a follow up phone call 4 weeks after the introductory session to promote adherence to home practice.",[13,24],{"label":30,"type":10,"description":31,"interventionNames":32},"20 minute session, home practice e-health, phone call","This intervention arm consists of mind body skill introduction session that is 20 minutes in duration. The daily home practice component for headache management will utilize a migraine specific interactive web portal, Migraine e-health portal. This arm will also receive a follow up phone call 4 weeks after the introductory session to promote adherence to home practice.",[33,14,15],"Behavioral: 20 minute session",{"label":35,"type":10,"description":36,"interventionNames":37},"20 minute session, home practice e-health, no phone call","This intervention arm consists of mind body skill introduction session that is 20 minutes in duration. The daily home practice component for headache management will utilize a migraine specific interactive web portal, Migraine e-health portal. This arm will not receive a follow up phone call 4 weeks after the introductory session to promote adherence to home practice.",[33,14],{"label":39,"type":10,"description":40,"interventionNames":41},"20 minute session, home practice handout, phone call","This intervention arm consists of mind body skill introduction session that is 20 minutes in duration. The daily home practice component for headache management will utilize a handout with explanations of mind body skills and a home practice plan. This arm will also receive a follow up phone call 4 weeks after the introductory session to promote adherence to home practice.",[33,24,15],{"label":43,"type":10,"description":44,"interventionNames":45},"20 minute session, home practice handout, no phone call","This intervention arm consists of mind body skill introduction session that is 20 minutes in duration. The daily home practice component for headache management will utilize a handout with explanations of mind body skills and a home practice plan. This arm will not receive a follow up phone call 4 weeks after the introductory session to promote adherence to home practice.",[33,24],[47,53,57,61,65],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"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.",[17,9,26,21],null,{"type":48,"name":54,"description":55,"armGroupLabels":56,"otherNames":52},"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.",[35,30,43,39],{"type":48,"name":58,"description":59,"armGroupLabels":60,"otherNames":52},"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.",[35,30,17,9],{"type":48,"name":62,"description":63,"armGroupLabels":64,"otherNames":52},"home practice handout","Participants will be given a handout of commercially available free apps relevant to the mind body skills introduced.",[43,39,26,21],{"type":48,"name":66,"description":67,"armGroupLabels":68,"otherNames":52},"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\u002Fhome practice completion.",[30,39,9,21],[70],{"name":71,"affiliation":5,"role":72},"Scott Powers, PhD","PRINCIPAL_INVESTIGATOR",[74],{"name":75,"role":76,"phone":77,"phoneExt":52,"email":78},"LeighAnn Chamberlin, MEd","CONTACT","513-636-9739","leighann.chamberlin@cchmc.org",[80,94],{"facility":81,"status":82,"city":83,"state":84,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":52},"University of Colorado\u002FChildren's Hospital Colorado","ACTIVE_NOT_RECRUITING","Aurora","Colorado","80045","United States","US",{"type":89,"coordinates":90},"Point",[91,92],-104.83192,39.72943,{"lat":92,"lon":91},{"facility":95,"status":96,"city":97,"state":98,"zip":99,"country":86,"countryCode":87,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Cincinnati Children's Hospital Medical Center","RECRUITING","Cincinnati","Ohio","45229",{"type":89,"coordinates":101},[102,103],-84.51439,39.12711,{"lat":103,"lon":102},[106],{"name":107,"role":76,"phone":108,"phoneExt":52,"email":109},"Leigh Ann Chamberlin","5136369737","LeighAnn.Chamberlin@cchmc.org",{"type":111,"investigatorFullName":52,"investigatorTitle":52,"investigatorAffiliation":52,"oldNameTitle":52,"oldOrganization":52},"SPONSOR",[113],{"name":114,"class":115},"National Center for Complementary and Integrative Health (NCCIH)","NIH","100417438","mind-body-balance-for-pediatric-migraine-100417438",false,"NCT04715685","Mind Body Balance for Pediatric Migraine","Inclusion Criteria:\n\n* Diagnosis: Migraine with or without aura or chronic migraine that meets the International Classification of Headache Disorders(ICHD) criteria\n* Frequency: Headache frequency based upon prospective headache diary of 28 days must be ≥ 4 and ≤ 28.\n* PedMIDAS: PedMIDAS Disability Score \\> 4, indicating at least mild disruption in daily activities and \\\u003C 140, indicating extreme disability that may require more comprehensive, multi-component therapy\n* Use of one or more of the following prescribed nutraceuticals and\u002For 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\u002FCholecalciferol), Depakote (Divalproate), Inderal (Propanerol), Elavil ((Amitripyline), Topamax (Topiramate), Periactin (Cyproheptadine)\\]\n* Language: English speaking, able to complete interviews and questionnaires in English\n\nExclusion Criteria:\n\n* Continuous migraine defined as unrelenting headache for a 28 day period\n* 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)\n* PedMIDAS Disability Score \\> 140, indicating extreme disability that may require more comprehensive, multi-component therapy\n* Youth who are pregnant, or those who are sexually active and not using a medically accepted form of contraception (barrier or hormonal methods)\n* 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","ALL","10 Years","17 Years",{"count":126,"type":127},260,"ESTIMATED","INTERVENTIONAL",[130],"NA","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.",[133,134,135,136,137,138,139,140],"Headache","Headache Disorders","Headache, Migraine","Migraine","Migraine Disorders","Migraine With Aura","Migraine Without Aura","Chronic Migraine",[142,143,144,145,146,147,148,149,150,151],"headache","migraine","cognitive behavioral therapy","pediatrics","mind body intervention","diaphragmatic breathing","progressive muscle relaxation","imagery","relaxation","biofeedback","2026-06-14",{"date":154,"type":155},"2026-06-16","ACTUAL",{"date":157,"type":155},"2021-03-09",{"date":159,"type":127},"2026-11-30",{"name":5,"class":6},2]