Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-01-06 @ 10:08 AM
Study NCT ID:
NCT06245395
Status:
RECRUITING
Last Update Posted:
2024-02-22
First Post:
2024-01-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality as Distraction Analgesia and Anxiolysis for Pediatric Otolaryngology Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-21', 'studyFirstSubmitDate': '2024-01-29', 'studyFirstSubmitQcDate': '2024-01-29', 'lastUpdatePostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wong-Baker FACES Pain Scale', 'timeFrame': 'during the in clinic procedure'}, {'measure': 'Subjective Units of Distress Scale', 'timeFrame': 'during the in clinic procedure'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Virtual Reality', 'Otolaryngology']}, 'descriptionModule': {'briefSummary': 'The primary aim of this randomized controlled trial is to determine the efficacy of Virtual Reality in pediatric otolaryngology clinics as distraction analgesia and anxiolysis for patients undergoing otologic procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients, ages 7-17 years old, undergoing an in-office microscope ear examination with possible debridement/instrumentation by a single fellowship trained neurotologist .\n\nExclusion Criteria:\n\n* 1\\) patients with a history of chronic pain disorders 2) developmental delay including autism spectrum disorders 3) neurologic or seizure disorders 4) visual impairment 5) claustrophobia'}, 'identificationModule': {'nctId': 'NCT06245395', 'briefTitle': 'Virtual Reality as Distraction Analgesia and Anxiolysis for Pediatric Otolaryngology Procedures', 'organization': {'class': 'FED', 'fullName': 'Walter Reed National Military Medical Center'}, 'officialTitle': 'Virtual Reality as Distraction Analgesia and Anxiolysis for Pediatric Otolaryngology Procedures', 'orgStudyIdInfo': {'id': 'WalterReedNMMC - ENT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Virtual Reality Arm', 'description': 'Pediatric patient receiving Virtual Reality during the otologic procedure.', 'interventionNames': ['Device: Virtual Reality']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care Arm'}], 'interventions': [{'name': 'Virtual Reality', 'type': 'DEVICE', 'description': 'Meta Quest 2 Headset', 'armGroupLabels': ['Virtual Reality Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20889', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Human Protections Director', 'role': 'CONTACT', 'email': 'dha.bethesda.Walter-Reed-Med-Ctr.list.drp-leadership@health.mil', 'phone': '301-295-8239'}, {'name': 'Anthony Tolisano, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Walter Reed National Military Medical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'centralContacts': [{'name': 'Samuel Garrett, MD', 'role': 'CONTACT', 'email': 'samlgarrett@gmail.com', 'phone': '4085298722'}, {'name': 'Anthony Tolisano, MD', 'role': 'CONTACT', 'email': 'anthony.m.tolisano.mil@health.mil', 'phone': '8609677563'}], 'overallOfficials': [{'name': 'Anthony Tolisano, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'WRNMMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Walter Reed National Military Medical Center', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}