[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573674":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":40,"responsibleParty":73,"collaborators":12,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":12,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":12,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":100,"whyStopped":12,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Hospital Mutua de Terrassa","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"USUAL","NO_INTERVENTION","In the control group, we will perform the surgical procedure as usual, without any distraction maneuvers, under local anesthesia.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"VIRTUAL REALITY","EXPERIMENTAL","In the study group, we will perform the vasectomy under local anesthesia and provide patients with virtual reality glasses as a distraction technique, aiming to reduce intraoperative anxiety.",[18],"Device: Virtual reality",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DEVICE","Virtual reality","We will use a virtual reality glasses with the 'Lending Moments' program, where patients can experience a sunset on a paradise beach while listening to a soothing voice that guides them through the experience with relaxation and meditation techniques. During this time, we will proceed with the surgical intervention.",[14],[26],{"name":27,"affiliation":12,"role":28},"Olga Monistrol, RN, MsC, PhD","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":12,"email":34},"Maria Claret, Nurse","CONTACT","+34 699259588","mariaclaretgutierrez@gmail.com",{"name":36,"role":32,"phone":37,"phoneExt":38,"email":39},"Carles Castillo, Urological Doctor","+34649646220","61727","carlescastillo@mutuaterrassa.cat",[41],{"facility":42,"status":12,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Hospital Univesitari Mútua de Terrassa","Terrassa","Barcelona","08221","Spain","ES",{"type":49,"coordinates":50},"Point",[51,52],2.01667,41.56667,{"lat":52,"lon":51},[55,59,61,63,65,67,69,71],{"name":56,"role":32,"phone":57,"phoneExt":12,"email":58},"Pilar Arcusa","+34 937365050","parcusa@mutuaterrassa.es",{"name":60,"role":28,"phone":12,"phoneExt":12,"email":12},"Maria Claret, RN, MsC",{"name":62,"role":28,"phone":12,"phoneExt":12,"email":12},"Carles Castillo, Physician",{"name":64,"role":28,"phone":12,"phoneExt":12,"email":12},"Alba Gomariz, Physician",{"name":66,"role":28,"phone":12,"phoneExt":12,"email":12},"Josep M Gili, Physician",{"name":68,"role":28,"phone":12,"phoneExt":12,"email":12},"Josep M Caballero, PhD",{"name":70,"role":28,"phone":12,"phoneExt":12,"email":12},"Juan Camilo Pereira, Physician",{"name":72,"role":28,"phone":12,"phoneExt":12,"email":12},"Ignasi Gallardo, Physician",{"type":74,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100573674","virtual-reality-to-reduce-intraoperative-anxiety-in-vasectomies-under-local-anesthesia-100573674",false,"NCT06749353","Virtual Reality to Reduce Intraoperative Anxiety in Vasectomies Under Local Anesthesia","Distraction Manuever to Reduce Intraoperative Anxiety During Vasectomy Procedure Under Local Anesthesia","Inclusion Criteria:\n\n* Male\n* Age between 20 and 90 years old\n* Intervention between 8 am to 12 am.\n* Vasectomy under local anesthesia\n\nExclusion Criteria:\n\n* Language barrier\n* Oncological urological syurgery\n* Surgery time superior to 30 minuts\n* Intellectual disability\n* STAI Trait \\> 70%\n* Intervention after 12 am","MALE","20 Years","90 Years",{"count":86,"type":87},148,"ESTIMATED","INTERVENTIONAL",[90],"NA","Vasectomy is an elective and ambulatory surgery, typically performed under local anaesthesia. The most common problem that we have found among patients is the anxiety and the apprehension to face the procedure.\n\nVirtual reality (VR), as a novel tool, is relatively underutilized in such medical context. It has been successfully employed across various medical domains, aiding in the training of surgeons, enhancing procedural planning, and offering psychological support to patients.\n\nThis project aims to assess the effectiveness of employing distraction maneuverers, using virtual reality glasses, during the intraoperative period on vasectomy surgery, to mitigate anxiety during the surgical process.\n\nWe want to develop a randomized clinical trial, single-centre study with a control group (conventional procedure) and an intervention group (Virtual reality Glasses). Anxiety was measured using cortisol level through a biomarker saliva test, involving pre and post-procedure samples for each patient. Additionally, we used the State-Trait Anxiety Inventory (STAI) pre and post procedure to evaluate the anxiety and the correlation with the cortisol levels, To evaluate the patient's satisfaction with the used of VR glasses a satisfaction survey was developed. The study protocol has received approval from the ethical committee of our institution.\n\nThe investigators expect to find statistically significant differences in salivary cortisol levels on postoperative samples to prove that VR helps to have a better experience and reduce the intraoperative anxiety.",[93],"Anxiety",[95,96,97,98,99],"anxiety","biomarkers","cortisol","vasectomy","virtual reality","NOT_YET_RECRUITING","2025-01-08",{"date":103,"type":104},"2025-01-09","ACTUAL",{"date":106,"type":87},"2025-01",{"date":108,"type":87},"2026-12",{"name":5,"class":6},1]