[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654742":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":25,"studyPopulation":18,"armGroups":26,"interventions":39,"overallOfficials":18,"centralContacts":48,"locations":54,"responsibleParty":67,"collaborators":18,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":18,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":18,"enrollmentInfo":80,"targetDuration":18,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":92,"overallStatus":98,"whyStopped":18,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Trabzon Kanuni Education and Research Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"State-Trait Anxiety Inventory (STAI) Score","Evaluation of patient anxiety levels using the State-Trait Anxiety Inventory (STAI), comprising the State Anxiety (STAI-S) and Trait Anxiety (STAI-T) subscales. Both STAI-S and STAI-T are administered prior to the procedure, whereas only the STAI-S is administered following the procedure. Each subscale yields a score ranging from 20 to 80, where higher scores indicate greater severity of anxiety and lower scores indicate lower levels of anxiety.","Ten minutes before the procedure and ten minutes after the procedure",[14],{"measure":15,"description":16,"timeFrame":17},"Visual Analog Scale (VAS) Pain Score","Evaluation of patient pain intensity experienced during the procedure, assessed using the Visual Analog Scale (VAS) administered after the procedure. The scale ranges from 0 to 10, where higher scores indicate greater pain severity (worse outcomes) and lower scores indicate less pain or no pain (better outcomes).","Ten minutes after the procedure",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":24,"maskingDescription":18,"whoMasked":18},"NONE","The removal of ureteral double-J (DJ) stents is an essential procedure in urological practice. However, many patients express concerns regarding the potential for procedural pain, discomfort, and underlying anxiety, which can complicate the clinical experience. While various analgesic and anxiolytic strategies exist, there is a growing clinical imperative to evaluate effective, non-invasive, and non-pharmacological interventions to enhance patient comfort.\n\nThis prospective, randomized, interventional study will recruit patients scheduled for routine DJ stent removal. The study will allocate participants into an experimental group (receiving VR distraction during the procedure) and a control group (undergoing standard care). The VR intervention consists of immersive visual and auditory stimulation designed to divert the patient's attention from the invasive nature of the procedure.\n\nThe study will employ a longitudinal assessment approach:\n\n1. Pre-procedural baseline anxiety will be measured using the State-Trait Anxiety Inventory (STAI).\n2. Intra-procedural and immediate post-procedural pain will be assessed using the Visual Analog Scale (VAS).\n3. Comparative analysis will be performed to determine the statistical significance of VR implementation on these psychometric and pain scales.\n\nBy integrating virtual reality into the clinical workflow, this research aims to provide evidence-based insights into improving patient experience, potentially reducing the need for pharmaceutical pain management, and standardizing comfort protocols for outpatient urological interventions.",[27,33],{"label":28,"type":29,"description":30,"interventionNames":31},"VIRTUAL REALITY GROUP","EXPERIMENTAL","Patients will undergo double j stent removal while wearing virtual reality glasses for distraction.",[32],"Other: Virtual Reality Distraction",{"label":34,"type":35,"description":36,"interventionNames":37},"CONTROL GROUP","ACTIVE_COMPARATOR","Patients will undergo standart double j stent removal without any virtual reality intervention.",[38],"Other: Standart of care",[40,44],{"type":6,"name":41,"description":42,"armGroupLabels":43,"otherNames":18},"Virtual Reality Distraction","Immersive virtual reality headset used as a non-pharmacological distraction tool during the procedure to reduce pain and anxiety.",[28],{"type":6,"name":45,"description":46,"armGroupLabels":47,"otherNames":18},"Standart of care","Standart urological care and routine procedure for double j stent removal without any virtual reality intervention.",[34],[49],{"name":50,"role":51,"phone":52,"phoneExt":18,"email":53},"VOLKAN ENES CELIK, MD","CONTACT","+905358499061","volkanenescelik061@gmail.com",[55],{"facility":56,"status":18,"city":57,"state":18,"zip":18,"country":58,"countryCode":18,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Trabozn University Faculty of Medicine Kanuni Education and Research Hospital","Trabzon","Turkey (Türkiye)",{"type":60,"coordinates":61},"Point",[62,63],39.72694,41.005,{"lat":63,"lon":62},[66],{"name":50,"role":51,"phone":52,"phoneExt":18,"email":53},{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","VOLKAN ENES ÇELİK","UROLOGY RESIDENT","100654742","effect-of-virtual-reality-glasses-on-anxiety-and-pain-during-double-j-stent-removal-100654742",false,"NCT07805018","EFFECT OF VIRTUAL REALITY GLASSES ON ANXIETY AND PAIN DURING DOUBLE J STENT REMOVAL","EVALUATION OF THE EFFECT OF VIRTUAL REALITY GLASSES ON ANXIETY AND PAIN DURING DOUBLE J STENT REMOVAL USING STAI AND VAS SCORE SCALES","Inclusion Criteria:\n\n* Patients aged 18 years or older who have undergone ureter or kidney stone surgery and have a double j stent\n* Willingness and ability to participate voluntarily in the study and provide informed consent\n\nExclusion Criteria:\n\n* Patients with double j stents placed forreasons other than ureter or kidney stone surgery\n* History of motion sickness or vertigo experienced during previous virtual reality use\n* Visual impairments\n* History of epilepsy\n* Cognitive impairment of mental retardation\n* History of severe psychiatric disorders\n* Pregnant or breastfeeding women\n* Patients requesting double j stent removal under sedation","ALL","18 Years",{"count":81,"type":82},100,"ESTIMATED","INTERVENTIONAL",[85],"NA","This randomized controlled trial aims to investigate the impact of Virtual Reality (VR) as a non-pharmacological distraction method on patient-reported pain and anxiety during the removal of ureteral double-J (DJ) stents. Despite being a standard urological procedure, stent removal is often reported by patients to be a source of significant anxiety and procedure-related pain. By utilizing a standardized distraction environment via VR goggles, this study evaluates whether this intervention can effectively modulate the patient's perception of the procedure. The primary outcomes are measured using the State-Trait Anxiety Inventory (STAI) to assess psychological anxiety and the Visual Analog Scale (VAS) to quantify the intensity of pain experienced throughout the stent removal process.",[88,89,90,91],"Double J Stent","Virtual Reality (VR) Technology","Anxiety","Pain",[93,94,95,96,97],"VIRTUAL REALITY GLASSES","PAIN","ANXIETY","URETERAL STENT","URETERAL STENT REMOVAL","NOT_YET_RECRUITING","2026-09-03",{"date":101,"type":102},"2026-09-04","ACTUAL",{"date":104,"type":82},"2026-09-01",{"date":106,"type":82},"2027-07-01",{"name":69,"class":6},1]