[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100495982":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":72,"collaborators":26,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":26,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":26,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"University of Oslo","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","After 2 weeks mapping phase, patient-specific HR-informed intervention from week 3.",[13],"Behavioral: HR-informed change in routine",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","ACTIVE_COMPARATOR","After 4 weeks mapping phase, patient-specific HR-informed intervention from week 5.",[19],"Behavioral: Delayed HR-informed specific change in routine",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","HR-informed change in routine","The intervention is given for a situation occuring at least ten times and accompanied by an increase in HR at least 80% of the time, during the two-week registration period. Change in care (intervention) is introduced from week 3.\n\nThe intervention is in one of four forms:\n\n1. changes in physiotherapy, e.g., less rigorous movement in the identified painful stretch,\n2. preparations for putting on corrective cast to stabilize joint and\u002For stretch spastic muscles,\n3. change in procedures for transportation\u002Flifting, e.g., new technique or adaptations made to equipment, or\n4. revised personal hygiene procedure.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Delayed HR-informed specific change in routine","The intervention is given for a situation occuring at least twenty times and accompanied by an increase in HR at least 80% of the time, during the four-week registration period. Change in care (intervention) is introduced from week 5.\n\nThe intervention is in one of four forms:\n\n1. changes in physiotherapy, e.g., less rigorous movement in the identified painful stretch,\n2. preparations for putting on corrective cast to stabilize joint and\u002For stretch spastic muscles,\n3. change in procedures for transportation\u002Flifting, e.g., new technique or adaptations made to equipment, or\n4. revised personal hygiene procedure.",[15],[32],{"name":33,"affiliation":5,"role":34},"Bjørnar Hassel","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Bjørnar Hassel, Professor","CONTACT","0047 98829754","bjornar.hassel@medisin.uio.no",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Emilie SM Kildal","45481949","eskildal@uio.no",[46,61],{"facility":47,"status":48,"city":49,"state":26,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Oslo University Hospital","RECRUITING","Oslo","0192","Norway","NO",{"type":54,"coordinates":55},"Point",[56,57],10.74609,59.91273,{"lat":57,"lon":56},[60],{"name":37,"role":38,"phone":26,"phoneExt":26,"email":26},{"facility":5,"status":48,"city":49,"state":26,"zip":62,"country":51,"countryCode":52,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"0450",{"type":54,"coordinates":64},[56,57],{"lat":57,"lon":56},[67,70],{"name":68,"role":38,"phone":69,"phoneExt":26,"email":40},"Bjørnar Hassel, PhD","004798829754",{"name":42,"role":38,"phone":71,"phoneExt":26,"email":44},"004745481949",{"type":34,"investigatorFullName":33,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Professor","100495982","heart-rate-informed-changes-in-care-for-non-communicating-patients-100495982",false,"NCT05738278","Heart Rate Informed Changes in Care for Non-Communicating Patients","Heart Rate Informed Changes in Care for Non-Communicating Patients: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Between 5 and 70 years of age at the time of data collection\n* Autism spectrum disorder as evaluated by clinical psychologist\n* Communication difficulties\n* Living at a care home with round-the-clock staff for at least five days a week; or attending one-to-one staffed school\u002Fday-care at least five days a week.\n* Written informed consent is obtained from the subjects' legal representative.\n\nExclusion Criteria:\n\n\\- Having any autoimmune disorder or any type of cancer with ongoing chemotherapy.","ALL","5 Years","70 Years",{"count":85,"type":86},38,"ESTIMATED","INTERVENTIONAL",[89],"NA","The overarching aim is to generate knowledge to reduce incidence of pain in non-verbal patients' everyday life. The trial will 1) evaluate how HR can be used to identify potentially painful care procedures that should be re-evaluated in terms of the approach taken; 2) test the effect of heart rate (HR)-informed changes in potentially painful care procedures on biomarkers of pain, and 3) assess how six weeks of communication through HR affects the quality of communication between patient and caregiver.",[92,93,94],"Autism Spectrum Disorder","Intellectual Disability","Communication, Nonverbal",[96,97,93,98,99,100,101,102,103],"Heart Rate","Autistic Disorder","Social Interaction","Caregivers","Developmental Disabilities","Communication","Biomarkers","Pain","2025-07-01",{"date":106,"type":107},"2025-07-04","ACTUAL",{"date":109,"type":107},"2023-02-27",{"date":111,"type":86},"2025-12-30",{"name":5,"class":6},2]