Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:48 PM
Study NCT ID:
NCT07277894
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-11
First Post:
2025-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Virtual Reality During Urodynamics on Vital Signs, Anxiety, and Satisfaction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-29', 'studyFirstSubmitDate': '2025-08-22', 'studyFirstSubmitQcDate': '2025-11-29', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in State Anxiety Score (State-Trait Anxiety Inventory - STAI-State)', 'timeFrame': 'Baseline and immediately after the procedure', 'description': 'State Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI-State), a 20-item scale ranging from 20 to 80 points. Higher scores indicate higher anxiety. Unit of Measure: points (20-80)'}], 'secondaryOutcomes': [{'measure': 'Uroflowmetry Parameters (Qmax, Qavg, voided volume, flow time)', 'timeFrame': 'During the procedure', 'description': 'Uroflowmetry parameters including maximum flow rate (Qmax, mL/s), average flow rate (Qavg, mL/s), voided volume (mL), and flow time (seconds) will be recorded during the procedure. Unit of Measure: mL/s; mL; seconds'}, {'measure': 'Change in Vital Signs (blood pressure, heart rate, respiratory rate, oxygen saturation)', 'timeFrame': 'Baseline and immediately after procedure', 'description': 'Vital signs (systolic/diastolic blood pressure in mmHg, heart rate in bpm, respiratory rate in breaths/min, and SpO₂ in %) will be measured before and after the uroflowmetry procedure. Unit of Measure: mmHg, bpm, breaths/min, %'}, {'measure': 'Patient Satisfaction Score (Visual Analog Scale - VAS)', 'timeFrame': 'Immediately after the procedure', 'description': 'Satisfaction will be assessed using a Visual Analog Scale ranging from 0 (no satisfaction) to 10 (highest satisfaction). Unit of Measure: VAS score (0-10)'}, {'measure': 'Patient Comfort Score (Visual Analog Scale - VAS)', 'timeFrame': 'Immediately after the procedure', 'description': 'Comfort will be assessed using a Visual Analog Scale ranging from 0 (no comfort) to 10 (highest comfort). Unit of Measure: VAS score (0-10)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Urinary incontinence', 'urodynamic studies', 'anxiety', 'satisfaction'], 'conditions': ['Urinary Incontinence', 'Urodynamic Studies', 'Urodynamics']}, 'descriptionModule': {'briefSummary': "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/Duration: 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/antidepressants, communication/vision/balance 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 \\< 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.", 'detailedDescription': 'Background:\n\nUrodynamic studies are essential diagnostic tools for evaluating lower urinary tract function. However, they often cause discomfort, pain, and anxiety, which may negatively affect patient experience and the accuracy of clinical results. Non-pharmacological interventions such as music therapy and aromatherapy have been shown to reduce anxiety. Virtual reality (VR) is a promising new approach that provides immersive distraction and has demonstrated benefits in clinical care, but its use in urodynamic testing remains limited.\n\nObjective:\n\nTo evaluate the effects of VR application during non-invasive urodynamics on:\n\nVital signs\n\nAnxiety\n\nComfort\n\nPatient satisfaction\n\nDesign and Setting:\n\nSingle-center, randomized controlled clinical trial. Location: Urology Outpatient Clinic, Ankara Etlik City Hospital. Study period: November 2025 - January 2026.\n\nParticipants:\n\nMinimum 52 participants (26 per group).\n\nInclusion criteria: Adults aged 18-50, undergoing non-invasive urodynamics for the first time, voluntary participation.\n\nExclusion criteria: Previous urodynamics, antidepressant/anxiolytic use, communication problems, visual or balance disorders.\n\nRandomization:\n\nBlock randomization (block size = 6).\n\nInterventions:\n\nVR Group: During uroflowmetry, participants will use VR goggles displaying a 360° visualization of a hygienic and spacious bathroom environment.\n\nControl Group: Routine clinical practice only, with standard pre-procedure information.\n\nMeasurements and 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\nData Collection and Analysis:\n\nAssessments conducted before, during, and after urodynamics.\n\nStatistical analyses with SPSS 21.0.\n\nNormality tested with Kolmogorov-Smirnov.\n\nGroup comparisons with Independent Samples t-test or Mann-Whitney U test.\n\nSignificance level: p \\< 0.05.\n\nEthics:\n\nApproved by the Gülhane Research Ethics Committee. Institutional approval obtained. Written informed consent will be collected from all participants.\n\nExpected Contribution:\n\nThis trial will provide evidence on the role of VR in reducing anxiety, improving comfort, and enhancing patient satisfaction during urodynamic procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '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.'}, 'identificationModule': {'nctId': 'NCT07277894', 'briefTitle': 'The Effect of Virtual Reality During Urodynamics on Vital Signs, Anxiety, and Satisfaction', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': "The Effect of Virtual Reality During Non-Invasive Urodynamics on Patients' Vital Signs, Anxiety, and Satisfaction Levels", 'orgStudyIdInfo': {'id': 'SagligBilimleriU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'virtual reality group', 'description': '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.', 'interventionNames': ['Other: Virtual reality group']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The control group participants will not be equipped with virtual reality headsets, and only routine clinical procedures will be administered.'}], 'interventions': [{'name': 'Virtual reality group', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['virtual reality group']}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data will be available beginning 6 months after publication of the primary study results and will remain accessible for up to 5 years.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) related to primary and secondary outcomes will be shared. Supporting information including the study protocol, statistical analysis plan (SAP), informed consent form (ICF), and clinical study report (CSR) will also be made available.', 'accessCriteria': 'Access will be provided to qualified researchers who submit a methodologically sound proposal and obtain approval from an independent ethics committee. Requests should be directed to the Principal Investigator via institutional email.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator and Lecturer', 'investigatorFullName': 'Esra Özden', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi'}}}}