[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639947":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":27,"locations":33,"responsibleParty":47,"collaborators":26,"id":51,"slug":26,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":26,"enrollmentInfo":59,"targetDuration":26,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":72,"whyStopped":26,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"University Hospital, Geneva","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active Group (immediate)","EXPERIMENTAL","Virtual-reality based hypnotherapy session",[13],"Device: Virtual-reality hypnotherapy device",{"label":15,"type":6,"description":16,"interventionNames":17},"Active Group (wait list)","Wait list and acts as Control, then active intervention",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Virtual-reality hypnotherapy device","10-20 minute virtual-reality based hypnotherapy session with Hypno-VR device",[9,15],[25],"Hypno-VR",null,[28],{"name":29,"role":30,"phone":31,"phoneExt":26,"email":32},"Nicolas Nicastro, MD","CONTACT","+41223723521","nicolas.nicastro@hug.ch",[34],{"facility":35,"status":26,"city":36,"state":26,"zip":37,"country":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Geneva University Hospitals","Geneva","1206","Switzerland",{"type":40,"coordinates":41},"Point",[42,43],6.14569,46.20222,{"lat":43,"lon":42},[46],{"name":29,"role":30,"phone":31,"phoneExt":26,"email":32},{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Nicolas Nicastro","PD Dr","100639947",false,"NCT07614373","Virtual Reality-based Mindfulness Training for Mental Health After Stroke","VITAL","Inclusion Criteria:\n\n* Ischemic or hemorrhagic stroke \\>6 months before inclusion\n* Anxiety-HAD score at inclusion \\>= 8\n\nExclusion Criteria:\n\n* Blindness\n* Deafness\n* Photo-sensitive epilepsy\n* unstable psychiatric condition","ALL","18 Years",{"count":60,"type":61},48,"ESTIMATED","INTERVENTIONAL",[64],"NA","Background: anxiety has a high prevalence in stroke patients and can dampen recovery of motor and cognitive impairment. Psychotropic medication can induce cognitive side effects, while psychotherapy and mindfulness-based stress reduction programs can be difficult to implement and are demanding for patients.\n\nAim: to evaluate the effect of a virtual reality (VR)-based medical device (HypnoVR®) on anxiety and stress reduction in patients with chronic stroke. Other outcomes, including depression, neurological fatigue and quality of life will be assessed.\n\nMethodology: a randomized controlled trial including patients who had an ischemic or hemorrhagic stroke (\\>6 months) and experience significant anxiety - Hospital Anxiety and Depression Scale (HADS) ≥ 8 for anxiety. Intervention includes 3 weekly HypnoVR® sessions for 3 weeks (total: 9), with clinical assessments at baseline, post-intervention (end of week 3) and at a 8-week follow-up. The sessions will be supervised by a research assistant and will take place in our outpatient clinic. Participants will be randomly assigned to either an immediate treatment group or a delayed treatment group (waiting list), the latter acting as both controls and active participants.\n\nPotential significance: VR-based therapeutic interventions are emerging as promising solutions to improve mental health but require solid scientific studies to assess their efficacy. This study provides a safe, non-invasive intervention for all included participants and could unveil its potential as an adjunctive therapy for mental health issues after stroke.",[67],"Stroke (Subacute)",[69,70,71],"stroke","virtual reality","anxiety","NOT_YET_RECRUITING","2026-05-20",{"date":75,"type":76},"2026-05-29","ACTUAL",{"date":78,"type":61},"2027-04-01",{"date":80,"type":61},"2029-03-31",{"name":49,"class":6},1]