[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519319":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":36,"responsibleParty":53,"collaborators":55,"id":59,"slug":18,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":18,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":18,"enrollmentInfo":67,"targetDuration":18,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":18,"overallStatus":38,"whyStopped":18,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"All India Institute of Medical Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Smartphone restriction","EXPERIMENTAL","Patients with headache with history of high smartphone use will be randomized into restriction and no-restriction arm.\n\nRestriction method:\n\nIn the 'run-in' period of four weeks, the smartphone usage will be assessed in terms of number of overall use. The patients will then be advised to cut down the usage by one-third in terms of usage hours. The compliance will be checked at the time of outcome assessment.",[13],"Behavioral: Smartphone restriction",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","Comparison:\n\nIn the 'run-in' period of four weeks, the smartphone usage will be assessed in terms of number of overall use. In the non-intervention group only the smartphone usage data will be collected in the study period. The non-smartphone users will be as another control arm.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"BEHAVIORAL","The patients will then be advised to cut down the usage by one-third in terms of usage hours. The compliance will be checked at the time of outcome assessment.",[9],[25],{"name":26,"affiliation":5,"role":27},"Deepti Vibha","PRINCIPAL_INVESTIGATOR",[29,33],{"name":26,"role":30,"phone":31,"phoneExt":18,"email":32},"CONTACT","+911126594485","deeptivibha@aiims.edu",{"name":34,"role":30,"phone":35,"phoneExt":18,"email":18},"Rajesh Singh","+911126594049",[37],{"facility":26,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","New Delhi","National Capital Territory of Delhi","110029","India","IN",{"type":45,"coordinates":46},"Point",[47,48],77.2148,28.62137,{"lat":48,"lon":47},[51],{"name":26,"role":30,"phone":52,"phoneExt":18,"email":32},"+91-011-26594485",{"type":27,"investigatorFullName":26,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Clinical Professor",[56],{"name":57,"class":58},"Council of Scientific and Industrial Research, India","OTHER_GOV","100519319",false,"NCT06041997","Smartphone Use Restriction as Treatment of Primary Headache","Smartphone Use Restriction as Treatment of Primary Headache: a Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n1. Patients ≥18 years of age\n2. Diagnosis of primary headache as per the ICHD3Beta classification (\"ICHD-3 The International Classification of Headache Disorders 3rd Edition\" n.d.)\n3. Willing and consenting to participate in the study.\n\nExclusion Criteria:\n\n* 1\\. Secondary headaches 2. Not consenting for participation or follow up","ALL","18 Years",{"count":68,"type":69},60,"ESTIMATED","INTERVENTIONAL",[72],"NA","The goal of this clinical trial is to study smartphone use restriction as a treatment modality in patients of primary headache. The main question\\[s\\] it aims to answer are:\n\n1. In patients with primary headache, does restriction of smartphone use lead to reduced consumption of medications (acute, prophylaxis, either or both)?\n2. In patients with primary headache, does restriction of smartphone use lead to better responsiveness to medications (acute, prophylaxis, either or both)?\n3. Can reduction of smartphone duration be used as a non-pharmacological treatment of primary headache?\n4. In patients with primary headache, is the type of smartphone use (phone calls, internet browsing, watching screen) determinant of the severity of headache?\n5. Can we make an addiction score to predict which patient should be advised to limit smartphone use based on the above information?\n6. In patients with primary headache, does restriction of smartphone use led to improvement in headache severity (frequency, intensity, duration, one of them or all).\n\nThe smartphone users may further be classified into low and high smartphone users depending upon the smartphone addiction questionnaire (SAQ) (appendix 1) usage score. SUs with 0-1 score on the SAQ were further grouped into low SUs, and patients with score ≥1 were grouped into high SUs. To create a homogenous group, only patients with high SU will be randomized to standard treatment (Arm C) and intervention group (Arm D).\n\nParticipants will be asked about their smartphone usage, and if found eligible, there will be a run-in period of 4 weeks after which they will be randomized to the intervention (smartphone restriction) or comparison group (no restriction recommended)",[75],"Headache Disorders","2024-11-28",{"date":78,"type":79},"2024-12-02","ACTUAL",{"date":81,"type":79},"2023-10-01",{"date":83,"type":69},"2026-11-30",{"name":5,"class":6},1]