Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-26 @ 8:52 PM
Study NCT ID:
NCT03689868
Status:
COMPLETED
Last Update Posted:
2023-04-20
First Post:
2018-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Limited-English Proficiency (LEP) Virtual Reality (VR) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D007802', 'term': 'Language'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-19', 'studyFirstSubmitDate': '2018-09-27', 'studyFirstSubmitQcDate': '2018-09-27', 'lastUpdatePostDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedural-Related Anxiety', 'timeFrame': 'Duration of intervention, approximately 20-30 minutes', 'description': 'Validated questionnaires regarding anxiety will be administers pre- and post-intervention (i.e virtual reality) and compared to those in the control arm (i.e no virtual reality)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['virtual reality'], 'conditions': ['Anxiety', 'Parents', 'Language']}, 'referencesModule': {'references': [{'pmid': '24882604', 'type': 'BACKGROUND', 'citation': "West AM, Bittner EA, Ortiz VE. The effects of preoperative, video-assisted anesthesia education in Spanish on Spanish-speaking patients' anxiety, knowledge, and satisfaction: a pilot study. J Clin Anesth. 2014 Jun;26(4):325-9. doi: 10.1016/j.jclinane.2013.12.008. Epub 2014 Jun 2."}, {'pmid': '22962543', 'type': 'BACKGROUND', 'citation': 'Fabiyi C, Rankin K, Norr K, Shapiro N, White-Traut R. Anxiety among Black and Latina Mothers of Premature Infants at Social-Environmental Risk. Newborn Infant Nurs Rev. 2012 Sep 1;12(3):132-140. doi: 10.1053/j.nainr.2012.06.004.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset) are more effective than the standard of care (i.e., no technology based distraction) for preventing anxiety in parental and pediatric populations with limited English proficiency (LEP).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 0-99 (Child participants will be ages 0 to 17. Parents of children of any age may also be enrolled)\n* Able to consent\n* Self-identified as having a limited English proficiency or English-proficiency\n\nExclusion Criteria:\n\n* People who do not consent\n* Significant Cognitive Impairment\n* History of Severe Motion Sickness\n* Current Nausea\n* Seizures\n* Visual Problems\n* Patients whose children are clinically unstable or require urgent/emergent intervention'}, 'identificationModule': {'nctId': 'NCT03689868', 'briefTitle': 'Limited-English Proficiency (LEP) Virtual Reality (VR) Study', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Addressing Parental and Pediatric Anxiety Through Virtual Reality (VR) Intervention in (Limited-English Proficiency) LEP Populations', 'orgStudyIdInfo': {'id': '46551'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality', 'interventionNames': ['Behavioral: Virtual Reality']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Virtual Reality', 'type': 'BEHAVIORAL', 'description': 'Virtual Reality headset with calming scenery', 'armGroupLabels': ['Virtual Reality']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': "Lucile Packard Children's Hospital Stanford", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Samuel Rodriguez', 'investigatorAffiliation': 'Stanford University'}}}}