Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2026-01-10 @ 8:47 PM
Study NCT ID:
NCT07249359
Status:
COMPLETED
Last Update Posted:
2025-12-03
First Post:
2025-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality for Dental Anxiety in Children With Mild Intellectual Disability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008607', 'term': 'Intellectual Disability'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-11-18', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment success', 'timeFrame': 'Duration of procedure', 'description': 'Number of patients with completion of restorative dental procedure under local anesthesia within 50 minutes and positive overall treatment experience (dichotomous: success vs. failure)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intellectual Disabilities (F70-F79)']}, 'descriptionModule': {'briefSummary': 'Virtual reality (VR) is a promising non-pharmacological approach to reduce dental anxiety in children with neurodevelopmental disorders. This randomized controlled trial compared a VR-based distraction intervention with conventional monitor-based distraction in children aged 11-15 years with mild intellectual disability and moderate dental anxiety undergoing conservative dental treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 11-15; diagnosis of mild intellectual disability (DSM-5)\n* Moderate anxiety (Corah DAS 9-12)\n* ≥1 decayed tooth requiring conservative treatment under local anesthesia\n* Informed consent from parents/legal guardians\n\nExclusion Criteria:\n\n* no or slight anxiety\n* high or severe anxiety\n* visual disorders\n* neuromuscular comorbidities interfering with cooperation'}, 'identificationModule': {'nctId': 'NCT07249359', 'acronym': 'VR-MID', 'briefTitle': 'Virtual Reality for Dental Anxiety in Children With Mild Intellectual Disability', 'organization': {'class': 'OTHER', 'fullName': 'Oasi Research Institute-IRCCS'}, 'officialTitle': 'Effect of Virtual Reality on Dental Anxiety in Children With Mild Intellectual Disability: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'RC-2794677'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality Distraction', 'description': 'immersive VR software delivered through Meta Quest 3® headset during dental procedure', 'interventionNames': ['Device: Virtual Reality Distraction - immersive VR software delivered through Meta Quest 3® headset during dental procedure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control: Monitor-Based Distraction', 'description': 'cartoon video displayed in front of dental chair', 'interventionNames': ['Device: Control: Monitor-Based Distraction']}], 'interventions': [{'name': 'Virtual Reality Distraction - immersive VR software delivered through Meta Quest 3® headset during dental procedure', 'type': 'DEVICE', 'description': 'immersive VR software delivered through Meta Quest 3® headset during dental procedure', 'armGroupLabels': ['Virtual Reality Distraction']}, {'name': 'Control: Monitor-Based Distraction', 'type': 'DEVICE', 'description': 'cartoon video displayed in front of dental chair', 'armGroupLabels': ['Control: Monitor-Based Distraction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94018', 'city': 'Troina', 'state': 'EN', 'country': 'Italy', 'facility': 'IRCCS Ass. Oasi Maria SS', 'geoPoint': {'lat': 37.78437, 'lon': 14.59605}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oasi Research Institute-IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}