Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2026-03-01 @ 6:29 AM
Study NCT ID:
NCT06342193
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Virtual Reality Glasses on Anxiety During Cystoscopy: A Randomised Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-26', 'studyFirstSubmitDate': '2024-03-26', 'studyFirstSubmitQcDate': '2024-03-26', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anxiety', 'timeFrame': '30 minutes', 'description': 'State Trait Anxiety Scale-Situational Anxiety Scale'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cystoscopy', 'Virtual Reality', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to investigate the effect of using virtual reality glasses as a distraction method on anxiety in men undergoing cystoscopy under local anaesthesia.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteering to participate in the research\n* 18 years of age or older\n* Male gender\n* undergoing a rigid cystoscopy procedure for the first time\n* Application of local anaesthesia\n\nExclusion Criteria:\n\n* Cognitive or physical disabilities that may prevent the use of virtual reality glasses.\n* Premedication before the procedure'}, 'identificationModule': {'nctId': 'NCT06342193', 'briefTitle': 'Effect of Virtual Reality Glasses on Anxiety During Cystoscopy: A Randomised Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Uşak University'}, 'officialTitle': 'Effect of Virtual Reality Glasses on Anxiety During Cystoscopy: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'virtual reality'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention group', 'description': 'This group will use virtual reality glasses during cystoscopy.', 'interventionNames': ['Device: virtual reality group']}, {'type': 'NO_INTERVENTION', 'label': 'controlled group', 'description': 'No intervention'}], 'interventions': [{'name': 'virtual reality group', 'type': 'DEVICE', 'description': 'This group will use virtual reality glasses as distraction during cystoscopy.', 'armGroupLabels': ['intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64100', 'city': 'Uşak', 'state': 'Center', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Yucel Can Danisman', 'role': 'CONTACT', 'email': '202201023@ogr.usak.edu.tr', 'phone': '+905532864569'}, {'name': 'Fatma Susam, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yucel Can Danisman', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ozan Ozavci', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Shahnaza Mahmudova', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Erkan Arslan, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Adem Tuncekin, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Bilgen Arikan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Usak Training and Research Hospital', 'geoPoint': {'lat': 38.67351, 'lon': 29.4058}}], 'centralContacts': [{'name': 'Bilgen Arikan, PhD', 'role': 'CONTACT', 'email': 'blgnkhy@gmail.com', 'phone': '+902762212121', 'phoneExt': '3081'}, {'name': 'Yucel Can Danisman', 'role': 'CONTACT', 'email': '202201023@ogr.usak.edu.tr', 'phone': '+905532864569'}], 'overallOfficials': [{'name': 'Yucel Can Danisman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Usak University Training and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uşak University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}