Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT07094451
Status:
RECRUITING
Last Update Posted:
2025-07-30
First Post:
2025-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Virtual Reality for Pain Control in US-Guided Obstetric Needle Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073818', 'term': 'Pain, Procedural'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-23', 'studyFirstSubmitDate': '2025-07-23', 'studyFirstSubmitQcDate': '2025-07-23', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short-form McGill Pain Questionnaire', 'timeFrame': 'Immediately post-procedure', 'description': "The Short-form McGill Pain Questionnaire (SF-MPQ) is used to assess procedural pain and its qualities, such as 'sharpness.' The total score ranges from 0 to 45, with higher scores indicating more pain. It includes subscales for Sensory (0-33), Affective (0-12), a Visual Analogue Scale (0-10), and Present Pain Intensity (0-5)."}], 'secondaryOutcomes': [{'measure': 'Acceptability of Intervention Measure (AIM)', 'timeFrame': 'Immediately post-procedure (procedure lasts approximately 20 minutes)', 'description': 'This is a short, 4-question survey that helps the research team understand how acceptable participants found the use of virtual reality (VR) during their procedure. Participants rate each statement (ex: "The VR intervention meets my approval") on a scale from 1 (completely disagree) to 5 (completely agree). The total score ranges from 4 to 20, with higher scores indicating greater acceptability of the VR experience.'}, {'measure': 'State-Trait Anxiety Inventory (STAI)', 'timeFrame': 'Immediately Pre-procedure and immediately post-procedure (procedure lasts approximately 20 minutes)', 'description': 'The STAI is a 20-item instrument assessing anxiety before and after procedure. Each item is rated on a 4-point scale from 1-4.\n\nTotal scale range from 20 to 80, with higher scores indicating higher state anxiety.'}, {'measure': 'Visual Analog Scale for Satisfaction', 'timeFrame': 'Immediately post-procedure (procedure lasts approximately 20 minutes)', 'description': 'This is a simple one-question survey where participants rate how satisfied they were with their overall procedure experience. They will mark their satisfaction on a scale from 1 to 10, where 1 means "not satisfied at all" and 10 means "completely satisfied." The total score ranges from 1 to 10, with higher scores indicating greater satisfaction.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Virtual reality', 'Procedural anxiety', 'Ultrasound-guided', 'Obstetric patients', 'Non-pharmacologic pain control', 'Immersive distraction'], 'conditions': ['Procedural Pain']}, 'descriptionModule': {'briefSummary': 'This is a single-site randomized controlled pilot study at Mount Sinai Hospital evaluating the effect of virtual reality on procedural pain and anxiety in obstetric patients undergoing ultrasound-guided needle procedures. Patients will be randomized to receive either VR or standard care during the procedure and complete validated questionnaires assessing pain, anxiety, intervention acceptability, and satisfaction.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Age ≥18\n* English-speaking\n* Undergoing ultrasound-guided needle procedure at Mount Sinai\n\nExclusion criteria:\n\n* History of seizures\n* Severe motion sickness'}, 'identificationModule': {'nctId': 'NCT07094451', 'briefTitle': 'Virtual Reality for Pain Control in US-Guided Obstetric Needle Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Virtual Reality for Pain Control During US-guided Needle Procedures in Obstetric Patients: A Prospective Pilot Study', 'orgStudyIdInfo': {'id': 'STUDY-25-00020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Patients without Virtual Reality (VR)', 'description': 'Standard of care procedure without virtual reality.', 'interventionNames': ['Procedure: Ultrasound']}, {'type': 'EXPERIMENTAL', 'label': 'Patients with Virtual Reality', 'description': 'Ultrasound-guided (US-Guided) procedure with virtual reality.\n\nParticipants will wear a Meta Quest 2 virtual reality headset during their ultrasound-guided needle procedure.', 'interventionNames': ['Device: Virtual Reality', 'Procedure: Ultrasound']}], 'interventions': [{'name': 'Virtual Reality', 'type': 'DEVICE', 'description': 'Meta Quest 2 virtual reality headset. The VR experience includes an interactive, immersive environment with classical music and wrist-controlled movement to match floating visual cues to a beat. The experience is designed to be soothing and require minimal movement.', 'armGroupLabels': ['Patients with Virtual Reality']}, {'name': 'Ultrasound', 'type': 'PROCEDURE', 'description': 'Ultrasound-guided (US-Guided) procedure', 'armGroupLabels': ['Patients with Virtual Reality', 'Patients without Virtual Reality (VR)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lauren Ferrera, MD', 'role': 'CONTACT', 'email': 'lauren.ferrara@mssm.edu'}, {'name': 'Daniel Katz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mount Sinai Obstetrics and Gynecology', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Lucy Shang, BA', 'role': 'CONTACT', 'email': 'lucy.shang@icahn.mssm.edu', 'phone': '212-241-7475'}], 'overallOfficials': [{'name': 'Daniel Katz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is a single-site, small-scale pilot study that does not include the collection of biospecimens or long-term follow-up data. The data collected are limited to de-identified questionnaire responses.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Vice Chair of Education for the Department of Anesthesiology, Pain, & Perioperative Medicine', 'investigatorFullName': 'Daniel Katz', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}