Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-01-24 @ 2:35 PM
Study NCT ID:
NCT06524934
Status:
COMPLETED
Last Update Posted:
2024-07-29
First Post:
2024-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality's Role in See&Treat Hysteroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D047708', 'term': 'Myofibroma'}, {'id': 'D004714', 'term': 'Endometrial Hyperplasia'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-24', 'studyFirstSubmitDate': '2024-07-18', 'studyFirstSubmitQcDate': '2024-07-24', 'lastUpdatePostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain pre procedure', 'timeFrame': '1 minute before the procedure', 'description': 'Level of pain the patient thinks she will experience, expressed on a 10-point numerical rating scale (NRS), from 0 indicating no pain to 10 corresponding to the worst pain (subjective criteria), before undergoing diagnostic and operative procedures.'}, {'measure': 'Anxiety pre procedure', 'timeFrame': '1 minute before the procedure', 'description': 'Level of anxiety the patient thinks she will experience, expressed on a 10-point numerical rating scale (NRS), from 0 indicating no anxiety to 10 corresponding to the worst anxiety (subjective criteria), before undergoing diagnostic and operative procedures.'}, {'measure': 'Pain post procedure', 'timeFrame': '1 minute after the procedure', 'description': 'Level of pain reported by the patient, expressed on a 10-point numerical rating scale (NRS), from 0 indicating no pain or anxiety, to 10 corresponding to the worst pain (subjective criteria), during diagnostic and operative procedures.'}, {'measure': 'Anxiety post procedure', 'timeFrame': '1 minute after the procedure', 'description': 'Level of anxiety reported by the patient, expressed on a 10-point numerical rating scale (NRS), from 0 indicating no pain or anxiety, to 10 corresponding to the worst anxiety (subjective criteria), during diagnostic and operative procedures.'}, {'measure': 'Heart rate (HR) pre procedure', 'timeFrame': '1 minute before the procedure', 'description': 'Heart rate (HR) collected by a dedicate nurse before diagnostic or operative procedures (objective criteria).'}, {'measure': 'Respiratory rate (RR) pre procedure', 'timeFrame': '1 minute before the procedure', 'description': 'Respiratory rate (RR) collected by a dedicate nurse before diagnostic or operative procedures (objective criteria).'}, {'measure': 'Heart rate (HR) during procedure', 'timeFrame': '5 minutes after the start of the procedure', 'description': 'Heart rate (HR) collected by a dedicate nurse during diagnostic or operative procedures (objective criteria).'}, {'measure': 'Respiratory rate (RR) during procedure', 'timeFrame': '5 minutes after the start of the procedure', 'description': 'Respiratory rate (RR) collected by a dedicate nurse during diagnostic or operative procedures (objective criteria).'}], 'secondaryOutcomes': [{'measure': 'Suspension rate of procedure', 'timeFrame': 'During procedure', 'description': 'Procedure completion and suspension rate (defined as the proportion of suspended procedures for any reasons)'}, {'measure': 'Time of procedure', 'timeFrame': 'During procedure', 'description': 'Recording the time of procedure'}, {'measure': 'Satisfaction rate', 'timeFrame': '5 minutes after the procedure', 'description': 'Satisfaction rate (Virtual reality group: desire to use the headset again in the future / Control group: desire to use headset if they could)'}, {'measure': 'Side effects', 'timeFrame': '5 minutes after the procedure', 'description': 'Reported side effects'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Outpatient Hysteroscopy', 'Virtual Reality Technology', 'Pain and Anxiety Management', 'See & Treat'], 'conditions': ['Endometrial Cancer', 'Endometrial Diseases', 'Myoma;Uterus', 'Endometrial Hyperplasia']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the feasibility and effectiveness of virtual reality technology in outpatient hysteroscopy to improve pain and anxiety management and spread the diffusion of see \\& treat philosophy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06524934', 'briefTitle': "Virtual Reality's Role in See&Treat Hysteroscopy", 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'The Impact of Virtual Reality Technology in the Era of See & Treat Hysteroscopy: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '112/24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Case group', 'description': 'The patients in this group undergo the procedure using virtual reality.', 'interventionNames': ['Device: Use of virtual reality during the hysteroscopic procedure']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The patients in this group undergo the procedure without the use of virtual reality.'}], 'interventions': [{'name': 'Use of virtual reality during the hysteroscopic procedure', 'type': 'DEVICE', 'description': 'In VR group patients underwent hysteroscopy with standard care but the addition of VRT provided by a VR headset and headphones with the use of a Hypno VR software.', 'armGroupLabels': ['Case group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '810131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'University of Naples Federico II', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}], 'overallOfficials': [{'name': 'Brunella Ms Zizolfi, AssProfessor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Federico II of Naples - Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Brunella Zizolfi', 'investigatorAffiliation': 'Federico II University'}}}}