Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-27 @ 11:18 PM
Study NCT ID:
NCT07017660
Status:
RECRUITING
Last Update Posted:
2025-06-15
First Post:
2025-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality Application During Cystoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic 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': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2025-06-04', 'studyFirstSubmitQcDate': '2025-06-04', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog scale', 'timeFrame': '1 day', 'description': 'Rating is done on a scale with a 10 cm horizontal or vertical ruler and "0" means dissatisfaction and "10" means the highest level of satisfaction.'}, {'measure': 'Visual Analog Scale', 'timeFrame': '1 day', 'description': 'Grading is made with a 10 cm long horizantal or vertical ruler on the scale and "0" means no pain and "10" means the most severe pain.'}, {'measure': 'Spielberg State Anxiety Scale', 'timeFrame': '1 day', 'description': 'The scale has a four-point Likert structure consisting of 20 items, and a total score of 20-80 is obtained.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cystoscopy', 'Pain', 'anxiety', 'satisfaction', 'virtual reality'], 'conditions': ['Virtual Reality', 'Rigid Cystoscopy']}, 'descriptionModule': {'briefSummary': 'This randomized controlled experimental study aimed to determine the effect of virtual reality glasses during cystoscopy on pain, anxiety and patient satisfaction.', 'detailedDescription': "Patients in the intervention arm; In order to evaluate pain, anxiety and patient satisfaction regarding the cystoscopy procedure, the patient's pain level will be assessed with the Visual Analog Scale 10 minutes before the procedure and the patient's anxiety level will be assessed with the State Anxiety Scale. Patients will be asked to wear virtual reality glasses starting three minutes before the procedure and until the procedure is completed. The patient will be shown a video of nature scenes with the virtual reality glasses and will also be made to listen to the sounds of water and birds. Routine institution procedures will be applied during the cystoscopy procedure. 10 minutes after the procedure, the patient's pain and satisfaction level will be assessed with the Visual Analog Scale and the patient's anxiety level will be assessed with the State Anxiety Scale.\n\nPatients in the control arm; To assess pain, anxiety, and patient satisfaction with the cystoscopy procedure, the patient's pain level will be assessed with the Visual Analog Scale and the patient's anxiety level will be assessed with the State Anxiety Scale 10 minutes before the procedure. Routine institution procedures will be applied during the cystoscopy procedure. 10 minutes after the procedure, the patient's pain and satisfaction levels will be assessed with the Visual Analog Scale and the patient's anxiety level will be assessed with the State Anxiety Scale."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age and older,\n* First elective and rigid cystoscopy performed under local anesthesia,\n* No vision, hearing and perception problems,\n* Open to communication and able to speak Turkish,\n* Patients who agree to participate in the study\n\nExclusion Criteria:\n\n* Contraindications for the procedure (lidocaine allergy, urinary tract infection, anatomical problems related to the urethra, etc.)\n* Use of any analgesic or sedative medication at least 4 hours before cystoscopy Patients who undergo manipulation such as J stent placement or removal and/or bladder biopsy.'}, 'identificationModule': {'nctId': 'NCT07017660', 'briefTitle': 'Virtual Reality Application During Cystoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Ankara Medipol University'}, 'officialTitle': 'Effect of Virtual Reality Application on Pain, Anxiety and Patient Satisfaction During Cystoscopy: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2025-022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'control group', 'description': 'Routine institution procedures will be applied during the cystoscopy procedure.', 'interventionNames': ['Other: No intervention']}, {'type': 'EXPERIMENTAL', 'label': 'virtual reality glasses', 'description': 'Patients will be asked to wear virtual reality glasses starting three minutes before the procedure and until the procedure is completed. The patient will be shown a video of nature scenes with the virtual reality glasses and will also be made to listen to the sounds of water and birds. Routine institution procedures will be applied during the cystoscopy procedure.', 'interventionNames': ['Other: virtual reality glasses']}], 'interventions': [{'name': 'virtual reality glasses', 'type': 'OTHER', 'description': 'Patients will be asked to wear virtual reality glasses starting three minutes before the procedure and until it is completed. With the virtual reality glasses, the patient will be shown a video of nature scenes and made to listen to the sounds of water and birds. Routine institutional procedures will be applied during the cystoscopy procedure.', 'armGroupLabels': ['virtual reality glasses']}, {'name': 'No intervention', 'type': 'OTHER', 'description': 'Routine institution procedures will be applied during the cystoscopy procedure.', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ankara Etlik City Hospital', 'role': 'CONTACT', 'email': 'etliksh.iletisim@saglik.gov.tr', 'phone': '+90 0 312 797 00 00'}, {'name': 'Hasan N. G. Göktuğ, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ankara Etlik City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Ayten Akkaya, PhD', 'role': 'CONTACT', 'email': 'aytenkoc81@gmail.com', 'phone': '+905052931663'}, {'name': 'Hasan N. G. Göktuğ, PhD', 'role': 'CONTACT', 'email': 'drgoksel@yahoo.com', 'phone': '+9003127970000'}], 'overallOfficials': [{'name': 'Ayten Akkaya, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara Medipol University Faculty of Health Sciences, Department of Nursing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ayten Akkaya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assist. Prof. Dr.', 'investigatorFullName': 'Ayten Akkaya', 'investigatorAffiliation': 'Ankara Medipol University'}}}}