Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 5:43 AM
Study NCT ID:
NCT04802460
Status:
COMPLETED
Last Update Posted:
2021-03-17
First Post:
2021-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality Effects on Pain During Hysteroscopy Hysteroscopy: A Randomized Control Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'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': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-16', 'studyFirstSubmitDate': '2021-03-12', 'studyFirstSubmitQcDate': '2021-03-16', 'lastUpdatePostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain scale', 'timeFrame': '10 minutes', 'description': 'The primary aim of this study is to see if virtual reality can decrease pain intensity during office hysteroscopies using a 100mm Visual Analogue Scale (VAS).'}], 'secondaryOutcomes': [{'measure': 'heart rate changes', 'timeFrame': '10 minutes', 'description': "The secondary outcomes will be change in pain score and change in participant's HR throughout the procedure to assess for sympathetic evidence of pain and anxiety."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain and Hysteroscopy']}, 'descriptionModule': {'briefSummary': 'The Objective of this study is to compare pain levels in women undergoing office-based hysteroscopies using Virtual Reality versus control in a randomized control prospective trial.', 'detailedDescription': 'The primary aim of this study is to see if virtual reality can decrease pain intensity during office hysteroscopies using a 100mm Visual Analogue Scale (VAS).\n\nA secondary aim will be to monitor heart rate for patients using virtual reality versus the controls during the procedure. Another secondary aim will be to time the length of the procedure as it is possible if pain perception is reduced, the procedure can be completed faster. Lastly, we would also want to evaluate both patient and surgeon satisfaction of the procedure with or without virtual reality by using a satisfaction questionnaire to assess for patients satisfaction with the procedure, with the VR intervention, perceived realism of VR game, and measure simulator sickness related to the VR game.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion criteria will be women over the age of 18 presenting for office hysteroscopy.\n\nExclusion Criteria:\n\nExclusion criteria included patients with visual or auditory impairment that would interfere with their ability to use the virtual reality set, English language non-fluency, history of opioid dependence/abuse, current narcotic use, or desire for narcotic use during the procedure.'}, 'identificationModule': {'nctId': 'NCT04802460', 'acronym': 'VR', 'briefTitle': 'Virtual Reality Effects on Pain During Hysteroscopy Hysteroscopy: A Randomized Control Trial', 'organization': {'class': 'OTHER', 'fullName': 'Medstar Health Research Institute'}, 'officialTitle': 'Virtual Reality Effects on Acute Pain During Office Hysteroscopy: A Randomized Control Study', 'orgStudyIdInfo': {'id': 'STUDY00001687'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'virtual reality', 'description': 'Patients assigned to the VR group will be engaged with the VR using a publicly available VR set. Both study groups will be directed to take 800mg ibuprofen 1 hour prior to scheduled surgery as standard pain management in our office.', 'interventionNames': ['Device: Virtual reality headset (The Guided Meditation VR App through Oculus Go headset)']}, {'type': 'NO_INTERVENTION', 'label': 'control arm', 'description': 'Patients in the control arm will undergo standard of care office hysteroscopy. Both study groups will be directed to take 800mg ibuprofen 1 hour prior to scheduled surgery as standard pain management in our office.'}], 'interventions': [{'name': 'Virtual reality headset (The Guided Meditation VR App through Oculus Go headset)', 'type': 'DEVICE', 'description': 'Patients assigned to the VR condition will engage with the VR using The Guided Meditation VR App through Oculus Go headset. They will enjoy up to a 10 minute video of an environment of their choosing. During this video they will listen to calming music and a guided meditation session.', 'armGroupLabels': ['virtual reality']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MHRI IRB', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medstar Health Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}