Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
Study NCT ID:
NCT06952192
Status:
COMPLETED
Last Update Posted:
2025-04-30
First Post:
2025-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality During Skin Prick Test
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System 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'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2025-04-22', 'studyFirstSubmitQcDate': '2025-04-29', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of procedural anxiety in pediatric patients undergoing skin prick test', 'timeFrame': 'during the procedure', 'description': 'The primary objective of this study was to evaluate the effectiveness of VR in reducing procedural anxiety in pediatric patients undergoing SPT. Anxiety levels were assessed using the CAM scale before (0), during (1), post procedure, i.e., one minute after the procedure (2).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['virtual reality', 'skin prick test', 'pediatric allergy', 'anxiety', 'pain', 'compliance'], 'conditions': ['Allergy']}, 'descriptionModule': {'briefSummary': 'Skin prick testing (SPT) is a cornerstone diagnostic procedure for identifying allergic sensitizations in pediatric patients. Despite being minimally invasive, it often provokes considerable anxiety, fear, and pain, potentially compromising test accuracy due to poor compliance. Virtual Reality (VR) has emerged as a promising non-pharmacological tool for procedural distress management, yet its application in allergy diagnostics remains underexplored.\n\nTo evaluate the effectiveness of VR in reducing procedural anxiety, fear, and pain, and in improving compliance in children undergoing SPT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a confirmed history of allergic symptoms related to either environmental or food allergens\n* between 4 and 18 years of age\n\nExclusion Criteria:\n\n* history of seizure disorders,\n* motion sickness,\n* severe developmental delay,\n* non-Italian-speaking patients\n* Participants who had used systemic antihistamines or corticosteroids within the past seven days'}, 'identificationModule': {'nctId': 'NCT06952192', 'briefTitle': 'Virtual Reality During Skin Prick Test', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'Effectiveness of Virtual Reality in Reducing Anxiety, Fear, and Pain in Pediatric Patients Undergoing Skin Prick Testing: A Cross-Over Study', 'orgStudyIdInfo': {'id': '11n24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual reality', 'interventionNames': ['Device: Virtual reality']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care'}], 'interventions': [{'name': 'Virtual reality', 'type': 'DEVICE', 'description': 'VR application via a head-mounted display one minute before and throughout the SPT procedure. The VR intervention utilized a Samsung Gear VR headset (Samsung, Seoul, South Korea) in conjunction with a Samsung S7 or S8 mobile device to provide an immersive and engaging experience. Children were allowed to choose from a range of age-appropriate VR content designed to enhance engagement and relaxation. Prior to the procedure, children were trained on how to use the headset by study staff to ensure a smooth experience.', 'armGroupLabels': ['Virtual reality']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Naples', 'country': 'Italy', 'facility': 'Univeristy of Naples Federico II', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor', 'investigatorFullName': 'Roberto Berni Canani, MD, PhD', 'investigatorAffiliation': 'Federico II University'}}}}