[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564708":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":28,"locations":34,"responsibleParty":61,"collaborators":11,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":11,"enrollmentInfo":72,"targetDuration":11,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":36,"whyStopped":11,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Centre Hospitalier Departemental Vendee","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Rectosigmoidoscopy with virtual reality headset","EXPERIMENTAL",null,[13],"Device: Virtual reality headset",{"label":15,"type":16,"description":11,"interventionNames":11},"Rectosigmoidoscopy without a virtual reality headset","NO_INTERVENTION",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":11},"DEVICE","Virtual reality headset","Use of a virtual reality headset during rectosigmoidoscopy",[9],[24],{"name":25,"affiliation":26,"role":27},"Morgane AMIL","Centre Hospitalier Départemental Vendée","PRINCIPAL_INVESTIGATOR",[29],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Clémentin GABORIAU","CONTACT","0251446572","clementin.gaboriau@ght85.fr",[35,49],{"facility":5,"status":36,"city":37,"state":11,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","La Roche-sur-Yon","85925","France","FR",{"type":42,"coordinates":43},"Point",[44,45],-1.42757,46.66974,{"lat":45,"lon":44},[48],{"name":25,"role":27,"phone":11,"phoneExt":11,"email":11},{"facility":50,"status":36,"city":51,"state":11,"zip":52,"country":39,"countryCode":40,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"Centre Hospitalier Universitaire Nantes","Nantes","44000",{"type":42,"coordinates":54},[55,56],-1.55336,47.21725,{"lat":56,"lon":55},[59],{"name":60,"role":27,"phone":11,"phoneExt":11,"email":11},"Michael COLLINS",{"type":62,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100564708","virtual-reality-headset-and-acceptability-of-rectosigmoidoscopy-in-ulcerative-colitis-a-randomised-controlled-trial-100564708",false,"NCT06632691","Virtual Reality Headset and Acceptability of Rectosigmoidoscopy in Ulcerative Colitis: a Randomised Controlled Trial","VIRTU","Inclusion Criteria:\n\n* Patients aged 18 or over with UC in the active phase or in remission of their disease\n* Patient who has already undergone rectosigmoidoscopy without general anaesthetic\n* Patient requiring rectosigmoidoscopy (with colonoscope and air insufflation) as part of routine care\n* Patient able to follow the Clinical Investigation protocol and having given written informed consent to participate\n* Patient affiliated to the social security system or entitled beneficiary\n\nExclusion Criteria:\n\n* Patients with Crohn disease or indeterminate colitis\n* Patients hospitalised with severe acute colitis, as defined by the truelove criteria.\n* Patients with a stoma in place or with a history of colorectal resection.\n* Patients with a contraindication to the use of the virtual reality headset:\n\n  * Psychotic patients or patients diagnosed with psychiatric disorders\n  * Patients with uncontrolled epilepsy\n  * Patients with visual problems (lack of binocular vision, blindness) and\u002For hearing problems (deafness) that prevent them from using virtual reality.\n* Patients taking part in another clinical research protocol having an impact on the objectives of the clinical investigation\n* Patients already randomized in the clinical investigation\n* Pregnant, parturient or breast-feeding patients\n* Patients under guardianship, curatorship or deprived of their liberty\n* Patient under activated protection mandate or family habilitation\n* Patients under court protection.","ALL","18 Years",{"count":73,"type":74},100,"ESTIMATED","INTERVENTIONAL",[77],"NA","Haemorrhagic rectocolitis is an inflammatory bowel disease that continuously affects the rectum and colon, with lesions that extend variably from the rectum into the upstream colon. This disease requires repeated assessment of both clinical activity (transcribed by the clinical Mayo score) and endoscopic activity. ACCEPT study showed that the acceptability of rectosigmoidoscopy is low, and the main determinants of this low acceptability were pain and bloating (51%) and embarrassment during the examination (30%).\n\nVirtual reality headsets has analgesic and anxiolytic properties, thanks to specially designed virtual environments that apply different principles such as medical hypnosis, music therapy and cardiac coherence to enhance therapeutic action.\n\nThe aim of our project is to study the benefit of medical hypnosis provided by the use of a virtual reality headset in terms of tolerance of lower digestive endoscopy in patients with ulcerative colitis.",[80],"Haemorrhagic Rectocolitis",[82],"Haemorrhagic rectocolitis","2025-07-31",{"date":85,"type":86},"2025-08-01","ACTUAL",{"date":88,"type":86},"2024-10-09",{"date":90,"type":74},"2027-04-09",{"name":5,"class":6},2]