[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556254":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":63,"collaborators":66,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":26,"enrollmentInfo":80,"targetDuration":26,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":95,"whyStopped":26,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Ciusss de L'Est de l'Île de Montréal","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Virtual reality","EXPERIMENTAL","Patients assigned to use a virtual reality headset during their surgery.",[13],"Device: Virtual reality headset",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","ACTIVE_COMPARATOR","Standard of care group.",[19],"Other: Standard of care",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Virtual reality headset","A brief overview of all three virtual reality scenarios will be shown in a consolidated video prior to letting the participant select the preferred scenario. The participant's choice of scenario will then be documented. Once paravertebral blocks are completed and the participants are in supine position and the surgeon is ready to disinfect, the VR headset will be applied on the face of the participants in the intervention group and the chosen scenario will be started. If at any point the patient expresses a desire to stop using VR during the surgery, we will first offer them an alternate scenario. If they reiterate their willingness to stop, with or without having experienced the new scenario, the headset will be removed for the remainder of the surgery.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard of care","Standard of care in anesthesia with patient-controlled sedation.",[15],[32],{"name":33,"affiliation":5,"role":34},"Pascal Laferriere-Langlois, MD, MSc","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+1 (819) 432-5847","pascal.laferriere-langlois@umontreal.ca",{"name":41,"role":37,"phone":42,"phoneExt":43,"email":44},"Nadia NG Godin, NR","+1 (514) 252-3400","3193","ngodin.hmr@ssss.gouv.qc.ca",[46],{"facility":47,"status":26,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal","Montreal East","Quebec","H1T2M4","Canada","CA",{"type":54,"coordinates":55},"Point",[56,57],-73.5075,45.63202,{"lat":57,"lon":56},[60,62],{"name":33,"role":37,"phone":61,"phoneExt":26,"email":39},"+1-819-432-5847",{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":34,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Pascal Laferrière-Langlois","Clinical assistant professor",[67],{"name":68,"class":69},"Paperplane Therapeutics","UNKNOWN","100556254","virtual-reality-for-anxiolysis-and-pharmacological-sparing-100556254",false,"NCT06522711","Virtual Reality for Anxiolysis and Pharmacological Sparing","Virtual Reality as a Strategy for Intra-operatory Anxiolysis and Pharmacological Sparing in Patients Undergoing Breast Surgeries : the V-RAPS Randomized Controlled Trial","V-RAPS","Inclusion Criteria:\n\n* Fully consented female patients above the age of 18 years;\n* Undergoing elective, awake, breast surgery performed under paravertebral block.\n\nExclusion Criteria:\n\n* Hearing or visual impairment;\n* History of epilepsy, seizure or severe dizziness;\n* Severe mental impairment;\n* Recent eye or facial surgery or wounds;\n* Inability to use the VR hand controller.","FEMALE","18 Years",{"count":81,"type":82},100,"ESTIMATED","INTERVENTIONAL",[85],"NA","The goal of this clinical trial is to learn if virtual reality can reduce propofol requirements in adult, female patients undergoing elective breast surgery under regional anesthesia. The main question it aims to answer is:\n\nCan virtual reality immersion reduce intra-operative propofol requirements in adult female patients undergoing elective breast surgery under regional anesthesia?\n\nResearchers will compare time and weight-adjusted average propofol requirements in both the intervention group and the control group to see if there is a reduction in sedative usage in the group using the virtual reality device.\n\nParticipants will be randomly assigned to either a virtual reality (intervention) group or a control group.\n\n* The patients in the virtual reality group will have a virtual reality headset on during the surgery with a preselected scenario of their choice.\n* Both groups will have access to patient-controlled sedation under the supervision of an anesthesiologist and will be permitted to self-administer propofol boluses as needed.",[88,89],"Virtual Reality","Propofol",[9,91,92,93,89,94],"Anxiety","Patient-controlled sedation","Pain","Breast surgery","NOT_YET_RECRUITING","2024-07-25",{"date":98,"type":99},"2024-07-26","ACTUAL",{"date":101,"type":82},"2024-09-01",{"date":103,"type":82},"2026-09-01",{"name":5,"class":6},1]