[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614307":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":18,"locations":18,"responsibleParty":23,"collaborators":18,"id":27,"slug":28,"hasResults":29,"nctId":30,"briefTitle":31,"officialTitle":32,"acronym":18,"eligibilityCriteria":33,"healthyVolunteers":34,"sex":35,"minAge":36,"maxAge":37,"enrollmentInfo":38,"targetDuration":18,"studyType":41,"phases":42,"briefSummary":44,"conditions":45,"keywords":49,"overallStatus":54,"whyStopped":18,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":18},{"fullName":5,"class":6},"Saglik Bilimleri Universitesi","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"virtual reality group","EXPERIMENTAL","In the course of noninvasive urodynamic testing, patients will be presented with a 360-degree visualization of a clean and spacious bathroom environment via virtual reality goggles.",[13],"Other: Virtual reality group",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","The control group participants will not be equipped with virtual reality headsets, and only routine clinical procedures will be administered.",null,[20],{"type":6,"name":21,"description":11,"armGroupLabels":22,"otherNames":18},"Virtual reality group",[9],{"type":24,"investigatorFullName":25,"investigatorTitle":26,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Esra Özden","Principal Investigator and Lecturer","100614307","the-effect-of-virtual-reality-during-urodynamics-on-vital-signs-anxiety-and-satisfaction-100614307",false,"NCT07277894","The Effect of Virtual Reality During Urodynamics on Vital Signs, Anxiety, and Satisfaction","The Effect of Virtual Reality During Non-Invasive Urodynamics on Patients' Vital Signs, Anxiety, and Satisfaction Levels","Inclusion Criteria:\n\n* Being the first to undergo noninvasive urodynamics;\n* Agreeing to participate in the study;\n* Being between the ages of 30-50.\n\nExclusion Criteria:\n\n* Having had a urodynamic test before;\n* Being on antidepressants or anxiolytics;\n* Having communication and cooperation problems;\n* Having visual or balance disorders.",true,"ALL","18 Years","50 Years",{"count":39,"type":40},60,"ESTIMATED","INTERVENTIONAL",[43],"NA","Study Topic\n\nThis research aims to evaluate the effects of virtual reality (VR) application during noninvasive urodynamics on patients' vital signs, anxiety, and satisfaction levels.\n\nSignificance of the Problem\n\nUrodynamic studies are essential diagnostic methods for assessing lower urinary tract functions.\n\nHowever, they often cause discomfort, pain, and high levels of anxiety in patients.\n\nThis not only negatively affects the patient experience but also creates uncertainty in clinical decision-making.\n\nPrevious studies have shown that nursing interventions such as music therapy, aromatherapy, and heating pads effectively reduce anxiety.\n\nRecently, VR technology has emerged as a promising tool to distract patients, thereby reducing pain and anxiety.\n\nAim of the Study\n\nTo investigate the effects of VR application during noninvasive urodynamics on:\n\nVital signs,\n\nAnxiety,\n\nComfort, and\n\nPatient satisfaction.\n\nMethodology\n\nDesign: Single-center, randomized controlled clinical trial.\n\nSetting\u002FDuration: Urology Outpatient Clinic, Ankara Etlik City Hospital, September - December 2025.\n\nSample: Based on power analysis, at least 26 patients per group; total minimum of 52 participants.\n\nInclusion criteria: 18-50 years old, undergoing noninvasive urodynamics for the first time, voluntary participation.\n\nExclusion criteria: Previous urodynamics, use of anxiolytics\u002Fantidepressants, communication\u002Fvision\u002Fbalance impairments.\n\nRandomization: Block randomization (block size 6).\n\nData Collection Tools\n\nDescriptive Characteristics Form\n\nState-Trait Anxiety Inventory (STAI)\n\nVital Signs and Urodynamic Parameters Monitoring Form\n\nPatient Satisfaction and Comfort Assessment (Visual Analog Scale - VAS)\n\nVR Application Satisfaction Form\n\nInterventions\n\nVR Group: During uroflowmetry, patients will experience a 360° virtual hygienic and spacious bathroom environment via VR goggles.\n\nControl Group: Routine clinical practice only, with standard pre-procedure information.\n\nData Analysis\n\nData will be analyzed using SPSS 21.0.\n\nNormality will be tested with Kolmogorov-Smirnov.\n\nBetween-group differences will be assessed using Independent Samples t-test or Mann-Whitney U test, as appropriate.\n\nStatistical significance will be set at p \\\u003C 0.05.\n\nEthical Considerations\n\nEthical approval and hospital permission were obtained.\n\nInformed consent will be collected from all participants prior to data collection.",[46,47,48],"Urinary Incontinence","Urodynamic Studies","Urodynamics",[50,51,52,53],"Urinary incontinence","urodynamic studies","anxiety","satisfaction","NOT_YET_RECRUITING","2025-11-29",{"date":57,"type":58},"2025-12-11","ACTUAL",{"date":60,"type":40},"2025-12-01",{"date":62,"type":40},"2026-01-15",{"name":5,"class":6}]