[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645455":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":32,"responsibleParty":51,"collaborators":26,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":26,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":26,"enrollmentInfo":64,"targetDuration":26,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":26,"overallStatus":73,"whyStopped":26,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"IRCCS San Raffaele","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A (Control)- Transperineal Prostate Biopsy under Local Anesthesia","ACTIVE_COMPARATOR","Participants undergo transperineal prostate biopsy performed under standard clinical practice using local anesthesia. Local anesthetic is administered according to institutional protocol prior to the procedure. No additional interventions or supportive devices are used in this arm. Patients receive routine peri-procedural monitoring and care as per standard of care.",[13],"Procedure: Standard Local Anesthesia",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm B (Experimental)- Local anesthesia + immersive VR headset","EXPERIMENTAL","Participants undergo transperineal prostate biopsy performed under standard clinical practice using local anesthesia, with the addition of an immersive virtual reality (VR) headset as a supportive intervention. The VR device is applied approximately 3-5 minutes before the start of the procedure and is worn continuously throughout the biopsy. The VR experience is used as a non-pharmacological distraction tool intended to reduce peri-procedural anxiety and pain.",[19],"Device: Immersive Virtual Reality (VR) Headset",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Standard Local Anesthesia","Transperineal prostate biopsy performed under standard clinical practice using local anesthesia administered according to institutional protocol. No additional supportive or experimental interventions are applied.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DEVICE","Immersive Virtual Reality (VR) Headset","Transperineal prostate biopsy performed under standard local anesthesia with the addition of an immersive virtual reality (VR) headset used as a non-pharmacological distraction tool. The VR device is applied approximately 3-5 minutes before the start of the procedure and worn continuously throughout the biopsy.",[15],[33],{"facility":34,"status":26,"city":35,"state":36,"zip":37,"country":36,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"IRCCS Ospedale San Raffaele","Milan","Italy","20132","IT",{"type":40,"coordinates":41},"Point",[42,43],9.18951,45.46427,{"lat":43,"lon":42},[46],{"name":47,"role":48,"phone":49,"phoneExt":26,"email":50},"Simone Scuderi","CONTACT","+39 02 2643 6922","scuderi.simone@hsr.it",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Prof. Alberto Briganti","Full Professor","100645455","use-of-a-virtual-reality-headset-during-prostate-biopsy-under-local-anesthesia-to-improve-the-patients-experience-100645455",false,"NCT07701421","Use of a Virtual Reality Headset During Prostate Biopsy Under Local Anesthesia to Improve the Patient's Experience","Use of a Virtual Reality Visor (REALICA®) as an Supplementary Tool to Local Anesthesia in Patients Undergoing Prostate Biopsy: A Randomized Clinical Trial","Inclusion Criteria:\n\n* The participant provides written informed consent for the trial\n* Male participants who are at least 18 years of age on the day of signing informed consent\n* Men undergoing transperineal prostate biopsy under local anesthesia\n\nExclusion Criteria:\n\n* Visual or hearing impairment that would prevent effective use of the virtual reality device\n* History of epilepsy or seizure disorders\n* Severe motion sickness or known susceptibility to cybersickness\n* Severe psychiatric disorders that, in the investigator's judgment, could interfere with study participation or outcome assessment","MALE","18 Years",{"count":65,"type":66},200,"ESTIMATED","INTERVENTIONAL",[69],"NA","This is a post-market clinical investigation evaluating the effect of immersive virtual reality (VR) as an adjunct to standard local anesthesia during transperineal prostate biopsy.\n\nTransperineal prostate biopsy under local anesthesia is commonly associated with patient anxiety, procedural discomfort, and vasovagal reactions, which may negatively impact patient experience and procedural tolerability. Non-pharmacological distraction techniques such as immersive VR have shown potential to reduce perceived pain and anxiety during short, invasive medical procedures by modulating cognitive attention and emotional response.\n\nThis study investigates whether the use of an immersive VR headset, added to standard local anesthesia, can reduce peri-procedural anxiety and pain compared to standard care alone. The intervention is designed to provide continuous audiovisual immersive distraction starting shortly before the procedure and continuing throughout the biopsy, without altering standard clinical workflow or increasing procedural invasiveness.\n\nThis is a randomized, controlled, parallel-group, 1:1 superiority trial with a single-blind (assessor-blinded) design. Participants undergoing transperineal prostate biopsy under local anesthesia will be randomly assigned to one of two groups: standard local anesthesia alone (control arm) or standard local anesthesia plus immersive VR (experimental arm).\n\nThe primary objective is to evaluate whether immersive VR reduces peri-procedural anxiety and pain compared with standard local anesthesia alone. Secondary objectives may include evaluation of patient satisfaction, tolerability of the VR intervention, and incidence of vasovagal reactions or procedural interruptions.\n\nThe study aims to generate evidence on the feasibility and clinical benefit of integrating immersive VR as a non-pharmacological supportive tool in urological diagnostic procedures.",[72],"Prostate Biopsy","NOT_YET_RECRUITING","2026-07-08",{"date":76,"type":77},"2026-07-14","ACTUAL",{"date":79,"type":66},"2026-09",{"date":81,"type":66},"2028-10",{"name":5,"class":6},1]