[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569222":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":42,"responsibleParty":56,"collaborators":45,"id":59,"slug":45,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":45,"enrollmentInfo":68,"targetDuration":45,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":82,"whyStopped":45,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"University Hospital, Grenoble","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"prostate biopsies without virtual reality hypnosis headset","ACTIVE_COMPARATOR","Biopsies are performed according to current recommendations",[13],"Device: prostate biopsy",{"label":15,"type":16,"description":17,"interventionNames":18},"prostate biopsies with virtual reality hypnosis headset","EXPERIMENTAL","Patient wearing a virtual reality headset put in place in the transfer room 15 minutes before the procedure and maintained throughout the procedure.",[13],[20],{"type":21,"name":22,"description":15,"armGroupLabels":23,"otherNames":24},"DEVICE","prostate biopsy",[15,9],[25],"experimental",[27],{"name":28,"affiliation":29,"role":30},"Gaelle GF FIARD, professor","university grenoble hospital","PRINCIPAL_INVESTIGATOR",[32,38],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Gaelle GF FIARD, Professor","CONTACT","0476767642","+33","gfiard@chu-grenoble.fr",{"name":39,"role":34,"phone":40,"phoneExt":36,"email":41},"Assilah AB BOUZIT, study co","0476767971","abouzit@chu-grenoble.fr",[43],{"facility":44,"status":45,"city":46,"state":45,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":45},"University Hospital Grenoble",null,"Grenoble","38043","France","FR",{"type":51,"coordinates":52},"Point",[53,54],5.71479,45.17869,{"lat":54,"lon":53},{"type":30,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"EssaiClinique_HYPNOSURG-VR","Professeur","100569222",false,"NCT06691438","Evaluation of the Effect on Pain of Attentional Diversion Associated with Hypnotic Induction by Virtual Reality (VRH) in Perioperative Prostate Biopsies Under Local Anesthesia:","Evaluation of the Effect on Pain of Attentional Diversion Associated with Hypnotic Induction by Virtual Reality (VRH) in Perioperative Prostate Biopsies Under Local Anesthesia: Prospective Randomized and Controlled Trial","HYPNOSURG-VR","Inclusion Criteria:\n\n* Adult patients who are candidates for ultrasound-guided prostate biopsies under local anesthesia, via transperineal or transrectal route\n* Patient having signed informed consent\n\nExclusion Criteria:\n\n* Patient suffering from blindness or any other visual handicap that contraindicates the use of the headset\n* Deaf or hard of hearing patients\n* Patients suffering from epilepsy and\u002For mental deficiency, and\u002For disorders of higher functions\n* Psychotic patients\n* Claustrophobic patients or those who cannot tolerate a mask over their eyes\n* Refusal of local anesthesia\n* Protected person (art. L1121-5 to L1121-8 of the CSP)","MALE","18 Years",{"count":69,"type":70},130,"ESTIMATED","INTERVENTIONAL",[73],"NA","The primary objective of the study is to prospectively compare perioperative pain assessed in patients undergoing targeted prostate biopsies, either transrectally or transperineally, under local anesthesia with or without a virtual reality hypnosis headset. The study was sized based on a mean pain reduction of 1.5 points on a numerical scale (0-10 NAS), with an estimate of procedure-related pain of 4.0 on the NAS scale.",[76],"Prostate Biopsy",[78,79,80,81],"Sedation","Pain","Hypnosis","Virtual Reality","NOT_YET_RECRUITING","2024-11-14",{"date":85,"type":86},"2024-11-15","ACTUAL",{"date":88,"type":70},"2024-12-01",{"date":90,"type":70},"2026-10-01",{"name":5,"class":6},1]