Ignite Creation Date:
2025-12-26 @ 10:37 AM
Ignite Modification Date:
2026-03-07 @ 9:19 PM
Study NCT ID:
NCT03220828
Status:
COMPLETED
Last Update Posted:
2019-04-16
First Post:
2017-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Technology-Based Stress Reduction Techniques Prior to Vascular Access
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013315', 'term': 'Stress, Psychological'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-12', 'studyFirstSubmitDate': '2017-06-01', 'studyFirstSubmitQcDate': '2017-07-13', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain Score', 'timeFrame': 'immediately post vascular access minus baseline', 'description': 'Peak Pain Score minus Baseline Pain Score(0-10)'}], 'secondaryOutcomes': [{'measure': 'Fear Score', 'timeFrame': 'immediately post vascular access minus baseline', 'description': 'Fear Faces'}, {'measure': 'Family Satisfaction', 'timeFrame': 'Immediatly Post Vascular Access', 'description': 'Family Satisfaction Survey'}, {'measure': 'Patient Satisfaction', 'timeFrame': 'Immediately Post Vascular Access', 'description': 'Patient Satisfaction Survey'}, {'measure': 'Patient Compliance', 'timeFrame': 'At the time of Vascular Access', 'description': 'Modified Induction Compliance Checklist'}, {'measure': 'Adverse Events', 'timeFrame': 'At the time of Vascular Access', 'description': 'Negative outcomes such as nausea, headache'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress, Emotional']}, 'descriptionModule': {'briefSummary': "Preprocedural, preoperative, and prevascular access anxiety in pediatric patients has been previously shown to increase the likelihood of family stressors, postoperative pain, agitation, sleep disturbances, and negative behavioral changes. The purpose of this study is to determine if a non-invasive distracting devices (Virtual Reality headset) is more effective than the standard of care (i.e., no technology based distraction) for preventing anxiety before vascular access among hospitalized children undergoing vascular access prior to anesthesia, procedures, surgery, blood draws, port access, or peripheral IV placement. The anticipated primary outcome will be reduction of child's anxiety during and after vascular access.", 'detailedDescription': 'Anxiety among children undergoing vascular access is common. Not only is high anxiety traumatic, but research indicates that high anxiety in children before surgery leads to adverse outcomes such as increased pain and analgesics requirements, delayed hospital discharge, and maladaptive behavioral changes. Treating anxiety may decrease any of these undesirable behaviors.\n\nIn this study, investigators hope to determine if technology based distractions (VR headsets) are more effective than standard care for preventing high anxiety before vascular access. As a secondary aim of the study, we seek to determine if the use of technology based distraction will result in higher parent and patient satisfaction, decreased fear, and increased compliance, while monitoring for side-effects of the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. be between ages of 7-18 years of age\n2. have comprehension of instructions in the English language\n3. have parental consent\n4. Pediatric patient must be undergoing non-emergent vascular access at Lucile Packard Children's Hospital in one of the 6 previously defined care areas (please see study design in Section 16).\n5. Children who are normally healthy (ASA I) or have a mild systemic disease (ASA II,III)-\n\nExclusion Criteria:\n\n1. Significant cognitive impairment/developmental delays per parental report or H\\&P.\n2. Children with ASA IV (severe systemic disease that is a constant threat to life) or ASA V (unstable patients not expected to survive \\>24hours or without the operation)\n3. H/o severe motion sickness, nausea, seizures"}, 'identificationModule': {'nctId': 'NCT03220828', 'briefTitle': 'Evaluation of Technology-Based Stress Reduction Techniques Prior to Vascular Access', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Evaluation of Technology-Based Stress Reduction Techniques Prior to Vascular Access', 'orgStudyIdInfo': {'id': '40232'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The control group will be provided standard of care, which is no use of technologies.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group VR', 'description': 'Interventional arm will use technology based distractions (Virtual Reality)', 'interventionNames': ['Behavioral: Technology Based Distractions']}], 'interventions': [{'name': 'Technology Based Distractions', 'type': 'BEHAVIORAL', 'description': 'Technology based distractions (VR headsets)', 'armGroupLabels': ['Intervention Group VR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': "Lucile Packard Children's Hospital at Stanford", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Samuel Rodriguez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor,Department of Anesthesiology, Perioperative and Pain Medicine', 'investigatorFullName': 'Samuel Rodriguez', 'investigatorAffiliation': 'Stanford University'}}}}