[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593996":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":61,"collaborators":26,"id":63,"slug":26,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":26,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":26,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Centre Hospitalier Eure-Seine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"virtual reality group","ACTIVE_COMPARATOR","Participants in this group receive a virtual reality session with a hypnotic objective during surgery performed under regional anesthesia. The device consists of a virtual reality headset offering immersive visual and auditory content in a calming environment chosen by the participant. The session begins before the administration of regional anesthesia and may continue throughout the surgical procedure.",[13],"Device: Virtual reality headset",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","PLACEBO_COMPARATOR","Participants in this group receive standard anesthetic and surgical care without the use of virtual reality.",[19],"Other: Standard Care (in control arm)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Virtual reality headset","Patients in the intervention group receive a virtual reality session with a hypnotic purpose during surgery under regional anesthesia. The device consists of a virtual reality headset providing visual and auditory immersion in a calming environment, freely chosen by the patient. The session begins before the regional anesthesia is administered and may continue throughout the entire surgical procedure",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard Care (in control arm)","Participants in this group receive standard anesthetic and surgical care without the use of virtual reality",[15],[32],{"name":33,"affiliation":5,"role":34},"Jean-Baptiste HARDY","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Lydia BEN BEKKOU","CONTACT","02 32 33 86 75","arc2.circe@ch-eureseine.fr",{"name":42,"role":38,"phone":39,"phoneExt":26,"email":43},"Dihia AIDENE","arc.circe@ch-eureseine.fr",[45],{"facility":5,"status":46,"city":47,"state":26,"zip":48,"country":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Évreux","27000","France",{"type":51,"coordinates":52},"Point",[53,54],1.15082,49.02414,{"lat":54,"lon":53},[57,59],{"name":58,"role":38,"phone":39,"phoneExt":26,"email":40},"BEN BEKKOU Lydia",{"name":60,"role":38,"phone":39,"phoneExt":26,"email":43},"AIDENE Dihia",{"type":62,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100593996",false,"NCT07013695","Evaluation of the Impact of Virtual Reality on Sedation Use in Patients Undergoing Regional Anesthesia for Scheduled Orthopedic Surgery","VIRTUALR","Inclusion Criteria:\n\n* Signed informed consent\n* Patient affiliated with or benefiting from a social security system\n* Patient aged 18 years or older\n* Patient requiring regional anesthesia for scheduled orthopedic surgery of the upper or lower limb\n\nExclusion Criteria:\n\n* Patient refusal to participate in the study\n* Device interfering with the surgical or anesthetic procedure\n* Premedication before arrival in the operating room\n* Psychiatric or cognitive disorders, communication disorders\n* Patient unable to understand the study (language barrier, psychological issues)\n* Emergency surgery","ALL","18 Years",{"count":72,"type":73},164,"ESTIMATED","INTERVENTIONAL",[76],"NA","The VIRTUALR study evaluates the effect of virtual reality combined with hypnosis on anxiety in patients undergoing orthopedic surgery under regional anesthesia. Patients are randomly assigned to two groups: one group receiving virtual reality and a control group without the device. Anxiety and satisfaction questionnaires are used to compare the two groups.",[79,80,81],"Orthopedic Procedure","Anesthesia","Sedation","2025-06-02",{"date":84,"type":85},"2025-06-10","ACTUAL",{"date":87,"type":85},"2024-07-18",{"date":89,"type":73},"2025-07-19",{"name":5,"class":6},1]