Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:26 AM
Study NCT ID:
NCT07328061
Status:
COMPLETED
Last Update Posted:
2026-01-08
First Post:
2025-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality for Anxiety and Pain Management in Transvaginal Ultrasound for Endometriosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'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': 'D001523', 'term': 'Mental Disorders'}, {'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', 'maskingDescription': 'This is an open-label study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants Are randomized to undergo either transvaginal ultrasound with virtual reality distraction or standard transvaginal ultrasound without virtual reality. Each participant is assigned to a single study arm for the duration of the study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 155}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-28', 'studyFirstSubmitDate': '2025-12-28', 'studyFirstSubmitQcDate': '2025-12-28', 'lastUpdatePostDateStruct': {'date': '2026-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in anxiety level measured by State Anxiety Inventory (STAI-S)Anxiety levels are assessed using the Stating', 'timeFrame': 'From immediately before the TVUS to immediately after completion of the examination.', 'description': 'Anxiety levels are assessed using the State Anxiety Inventory (STAI-S). It includes 20 items such as "I feel calm " and "I am tense ". Participates were instructed to circle the number that best describes how they felt at that moment from 1 to 4 (from "Not at all" to "Very much so"). The STAI-S questionnaire is scored by summing the responses to the individual items and the possible scores ranges from 20 to 80, where 20-37 refers to "no or low anxiety", 38-44 to "moderate anxiety", and 45-80 to "high anxiety" (45-80). The outcome measure is the change in STAI-S score from before to immediately after the TVUS examination'}], 'secondaryOutcomes': [{'measure': 'Change in pain intensity measured by Visual Analog scale (VAS)', 'timeFrame': 'From immediately before the TVUS to immediately after completion of the examination.', 'description': 'Pain intensity is assessed using a VAS . VAS is a self-reported measure of pain expressed as a number on a continuum between 1 ("no pain") and 10 ("worst pain").'}, {'measure': "Change in heart rate and blood pressure '(including mean arterial pressure) during TVUS", 'timeFrame': 'The outcome measure is the change in the heart rate and blood pressure from immediately before to immediately after the TVUS examination.', 'description': 'Heart rate and blood pressure level are measured as objective measures of emotional distress and pain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Virtual reality', 'VR distraction', 'Transvaginal Ultrasound', 'TVUS', 'Anxiety', 'Pain'], 'conditions': ['Endometriosis']}, 'descriptionModule': {'briefSummary': 'The goal of this study to evaluate whether virtual reality (VR)-based technology, designed to promote relaxation and support pain self-management, can reduce anxiety and pain during trans-vaginal ultrasound (TVUS) for endometriosis.\n\nParticipants, women undergoing TVUS for endometriosis will be randomly assigned to either VR distraction group (VR-TVUS) or a standard examination group (control).\n\nAnxiety and pain levels will be assessed immediately before and after the TVUS.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18 to 50 years.\n* Confirmed or suspected diagnosis of endometriosis.\n* Scheduled to undergo transvaginal ultrasound examination.\n* Ability to understand the study procedures and independently complete study questionnaires.\n* Provided written informed consent.\n\nExclusion Criteria:\n\n* History of epilepsy or seizure disorders.\n* History of migraines.\n* Visual or hearing impairment.\n* Diagnosed anxiety disorders.\n* Claustrophobia.\n* Current symptoms of dizziness or nausea.\n* Active respiratory tract infection.\n* Any contraindication to transvaginal ultrasound examination.'}, 'identificationModule': {'nctId': 'NCT07328061', 'acronym': 'VR Endo TVU', 'briefTitle': 'Virtual Reality for Anxiety and Pain Management in Transvaginal Ultrasound for Endometriosis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Effect of Virtual Reality on Anxiety and Pain During Trans-vaginal Ultrasound for Endometriosis: A Prospective Randomized Controlled Study.', 'orgStudyIdInfo': {'id': '0142-23-SMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VR- TVUS Group', 'description': 'Participants undergo TVUS while using immersive virtual reality distraction', 'interventionNames': ['Behavioral: Virtual reality - based distraction']}, {'type': 'NO_INTERVENTION', 'label': 'Contro Group - Standard TVUS', 'description': 'Participants undergo standard TVUS, without virtual reality or any additional distraction intervention.'}], 'interventions': [{'name': 'Virtual reality - based distraction', 'type': 'BEHAVIORAL', 'description': 'Participants use an immersive virtual reality headset during TVUS. The intervention consists of immersive three-dimensional (3D) VR distraction delivered a head-mounted display, allowing participants to engage with a computer-simulated virtual environment, with or without guided audio based mindfulness relaxation techniques. The intervention is designed to reduce pain and anxiety during US examination. Each session lasts approximately 10-15 minutes, and may include calming music or guided meditation audio', 'armGroupLabels': ['VR- TVUS Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ramat Gan', 'state': 'Central District', 'country': 'Israel', 'facility': 'Endometriosis Center, Sheba Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Michal Zajicek', 'investigatorAffiliation': 'Sheba Medical Center'}}}}