Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2026-01-01 @ 6:19 PM
Study NCT ID:
NCT03583450
Status:
COMPLETED
Last Update Posted:
2020-07-08
First Post:
2018-06-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Perioperative Virtual Reality for Pediatric Anesthesia
Sponsor:
Organization:
Raw JSON
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Total range 20 to 80 with higher scores indicating greater anxiety. The value is a sum of trait and state anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Induction Compliance Checklist', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Perioperative Virtual Reality Headset', 'description': 'Perioperative virtual reality headset with mobile app and routine anesthetic care'}, {'id': 'OG001', 'title': 'Control', 'description': 'Routine anesthetic care'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '(Day 0 + 30 minutes on average from initial baseline) During mask induction', 'description': 'Induction Compliance Checklist (An observational scale used to describe the compliance of a child during induction of anesthesia, range 0 to 11 with higher scores indicating less compliance)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Parental Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Perioperative Virtual Reality Headset', 'description': 'Perioperative virtual reality headset with mobile app and routine anesthetic care'}, {'id': 'OG001', 'title': 'Control', 'description': 'Routine anesthetic care'}], 'classes': [{'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '76', 'upperLimit': '84'}, {'value': '80', 'groupId': 'OG001', 'lowerLimit': '76', 'upperLimit': '83'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '(Day 0 + 45 minutes on average from initial baseline) After mask induction', 'description': '21-item parental satisfaction questionnaire after induction of general anesthesia (T3). Parental satisfaction score range: 21-84. Higher scores represent higher satisfaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Anesthesia Length', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Perioperative Virtual Reality Headset', 'description': 'Perioperative virtual reality headset with mobile app and routine anesthetic care\n\nPerioperative virtual reality headset with mobile app: Perioperative virtual reality headset with mobile app (Samsung Gear VR headset, ChariotVR software)'}, {'id': 'OG001', 'title': 'Control', 'description': 'Routine anesthetic care'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'spread': '91', 'groupId': 'OG000'}, {'value': '101', 'spread': '119', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '(Day 0 + 120 minutes on average from initial baseline) After exiting the OR', 'description': 'Length of time that patient received anesthesia care.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Surgery Length', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Perioperative Virtual Reality Headset', 'description': 'Perioperative virtual reality headset with mobile app (Samsung Gear VR headset, ChariotVR software) with routine anesthetic care'}, {'id': 'OG001', 'title': 'Control', 'description': 'Routine anesthetic care'}], 'classes': [{'categories': [{'measurements': [{'value': '62', 'spread': '85', 'groupId': 'OG000'}, {'value': '77', 'spread': '106', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '(Day 0 + 120 minutes on average from initial baseline) After exiting the OR', 'description': 'Length of surgery from procedure start to procedure finish', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pre-medication Given', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Perioperative Virtual Reality Headset', 'description': 'Perioperative virtual reality headset with mobile app (Samsung Gear VR headset, ChariotVR software) with routine anesthetic care'}, {'id': 'OG001', 'title': 'Control', 'description': 'Routine anesthetic care'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '(Day 0 + 30 minutes on average from initial baseline) On induction of anesthesia', 'description': 'Whether patient was given anxiolytic medication prior to induction of general anesthesia', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Parent Present for Induction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Perioperative Virtual Reality Headset', 'description': 'Perioperative virtual reality headset with mobile app (Samsung Gear VR headset, ChariotVR software) with routine anesthetic care'}, {'id': 'OG001', 'title': 'Control', 'description': 'Routine anesthetic care'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '(Day 0 + 30 minutes on average from initial baseline) On induction of anesthesia', 'description': 'Whether parent was present in operating room during induction of anesthesia', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Perioperative Virtual Reality Headset', 'description': 'Perioperative virtual reality headset with mobile app (Samsung Gear VR headset, ChariotVR software) with routine anesthetic care'}, {'id': 'FG001', 'title': 'Control', 'description': 'Routine anesthetic care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'hardware malfunction (battery depletion)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Perioperative Virtual Reality Headset', 'description': 'Perioperative virtual reality headset with mobile app (Samsung Gear VR headset, ChariotVR software) with routine anesthetic care'}, {'id': 'BG001', 'title': 'Control', 'description': 'Routine anesthetic care'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'spread': '2.3', 'groupId': 'BG000'}, {'value': '7.8', 'spread': '2.3', 'groupId': 'BG001'}, {'value': '8.0', 'spread': '2.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '131.8', 'spread': '12.8', 'groupId': 'BG000'}, {'value': '130.2', 'spread': '15.5', 'groupId': 'BG001'}, {'value': '131.0', 'spread': '14.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '32.9', 'spread': '11.9', 'groupId': 'BG000'}, {'value': '31.9', 'spread': '15.2', 'groupId': 'BG001'}, {'value': '32.4', 'spread': '13.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '18.5', 'spread': '4.0', 'groupId': 'BG000'}, {'value': '18.0', 'spread': '4.8', 'groupId': 'BG001'}, {'value': '18.2', 'spread': '4.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'ASA physical status classification', 'classes': [{'categories': [{'title': 'ASA 1', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'ASA 2', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'ASA 3', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The ASA Physical Status Classification System is used to assess and communicate a patient's pre-anesthesia medical co-morbidities. ASA I is the healthiest and ASA VI is a declared brain-dead patient.\n\n* ASA I: Normal healthy patient\n* ASA II: Patient with mild systemic disease\n* ASA III: Patient with severe systemic disease", 'unitOfMeasure': 'Participants'}, {'title': 'Prior general anesthesia', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of prior general anesthetics', 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '4.1', 'groupId': 'BG000'}, {'value': '2.7', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '3.0', 'spread': '4.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Prior general anesthetics', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Modified Yale Preoperative Anxiety Scale in preop', 'classes': [{'categories': [{'measurements': [{'value': '28.3', 'groupId': 'BG000', 'lowerLimit': '23.3', 'upperLimit': '28.3'}, {'value': '28.3', 'groupId': 'BG001', 'lowerLimit': '23.3', 'upperLimit': '28.3'}, {'value': '28.3', 'groupId': 'BG002', 'lowerLimit': '23.3', 'upperLimit': '28.3'}]}]}], 'paramType': 'MEDIAN', 'description': "mYPAS is an observational measure of children's preoperative anxiety consisting of 27 items divided into 5 categories: Activity, Vocalizations, Emotional Expressivity, State of Arousal and Use of Parent. Scores range from 22.5 to 100 with higher scores indicating greater anxiety.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Parental State-Trait Anxiety Inventory in preop', 'classes': [{'categories': [{'measurements': [{'value': '36.0', 'groupId': 'BG000', 'lowerLimit': '26.5', 'upperLimit': '42.8'}, {'value': '38.0', 'groupId': 'BG001', 'lowerLimit': '31.0', 'upperLimit': '45.0'}, {'value': '36.0', 'groupId': 'BG002', 'lowerLimit': '28.0', 'upperLimit': '44.5'}]}]}], 'paramType': 'MEDIAN', 'description': 'State-Trait Anxiety Inventory: Self-reported anxiety instrument containing two separate 2-item subscales that measure trait (baseline) and state (situational) anxiety. Range 20 to 80 with higher scores indicating greater anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-22', 'size': 27780, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-04-07T16:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-15', 'studyFirstSubmitDate': '2018-06-18', 'resultsFirstSubmitDate': '2020-04-06', 'studyFirstSubmitQcDate': '2018-06-28', 'lastUpdatePostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-15', 'studyFirstPostDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Anesthesia Length', 'timeFrame': '(Day 0 + 120 minutes on average from initial baseline) After exiting the OR', 'description': 'Length of time that patient received anesthesia care.'}, {'measure': 'Surgery Length', 'timeFrame': '(Day 0 + 120 minutes on average from initial baseline) After exiting the OR', 'description': 'Length of surgery from procedure start to procedure finish'}, {'measure': 'Pre-medication Given', 'timeFrame': '(Day 0 + 30 minutes on average from initial baseline) On induction of anesthesia', 'description': 'Whether patient was given anxiolytic medication prior to induction of general anesthesia'}, {'measure': 'Parent Present for Induction', 'timeFrame': '(Day 0 + 30 minutes on average from initial baseline) On induction of anesthesia', 'description': 'Whether parent was present in operating room during induction of anesthesia'}], 'primaryOutcomes': [{'measure': 'Perioperative Pediatric Anxiety (Change From Baseline)', 'timeFrame': '(Day 0 + 15 minutes on average from initial baseline) On entering the OR', 'description': 'Modified Yale Preoperative Anxiety Scale (Observational measure of anxiety in five categories (activity, emotional expressivity, state of arousal, vocalization, and use of parents); Total range 0 to 100 with higher scores indicating greater anxiety)'}, {'measure': 'Perioperative Pediatric Anxiety (Change From Baseline)', 'timeFrame': '(Day 0 + 30 minutes on average from initial baseline) During mask induction', 'description': 'Modified Yale Preoperative Anxiety Scale (Observational measure of anxiety in five categories (activity, emotional expressivity, state of arousal, vocalization, and use of parents); Total range 0 to 100 with higher scores indicating greater anxiety)'}], 'secondaryOutcomes': [{'measure': 'Perioperative Parental Anxiety (Change From Baseline)', 'timeFrame': '(Day 0 + 45 minutes on average from initial baseline) After mask induction', 'description': 'State-Trait Anxiety Inventory: Self-reported anxiety instrument containing two separate 2-item subscales that measure trait (baseline) and state (situational) anxiety. Total range 20 to 80 with higher scores indicating greater anxiety. The value is a sum of trait and state anxiety.'}, {'measure': 'Induction Compliance Checklist', 'timeFrame': '(Day 0 + 30 minutes on average from initial baseline) During mask induction', 'description': 'Induction Compliance Checklist (An observational scale used to describe the compliance of a child during induction of anesthesia, range 0 to 11 with higher scores indicating less compliance)'}, {'measure': 'Parental Satisfaction', 'timeFrame': '(Day 0 + 45 minutes on average from initial baseline) After mask induction', 'description': '21-item parental satisfaction questionnaire after induction of general anesthesia (T3). Parental satisfaction score range: 21-84. Higher scores represent higher satisfaction.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Virtual Reality', 'Pediatric Anesthesia'], 'conditions': ['Anxiety']}, 'referencesModule': {'references': [{'pmid': '32618627', 'type': 'DERIVED', 'citation': 'Jung MJ, Libaw JS, Ma K, Whitlock EL, Feiner JR, Sinskey JL. Pediatric Distraction on Induction of Anesthesia With Virtual Reality and Perioperative Anxiolysis: A Randomized Controlled Trial. Anesth Analg. 2021 Mar 1;132(3):798-806. doi: 10.1213/ANE.0000000000005004.'}]}, 'descriptionModule': {'briefSummary': "The goal of this study is to evaluate the use of immersive audiovisual distraction and virtual reality to reduce perioperative anxiety in pediatric patients undergoing surgery at UCSF Benioff Children's Hospital. The study plans to employ virtual reality headsets during induction of anesthesia in pediatric patients for elective surgery in a randomized clinical trial.", 'detailedDescription': "The goal of this study is to evaluate the use of immersive audiovisual distraction and virtual reality to reduce perioperative anxiety in pediatric patients undergoing surgery at UCSF Benioff Children's Hospital. The study plans to employ virtual reality headsets during induction of anesthesia in pediatric patients for elective surgery in a randomized clinical trial. We will be enrolling patients age 5-12 years presenting for elective surgery.\n\nPatients will be randomized to one of two groups: (1) virtual reality headset with routine anesthetic care and (2) routine anesthetic care only."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 5-12 years\n* Patients present in preoperative area for induction of general anesthesia for an elective surgery or procedure\n\nExclusion Criteria:\n\n* Patients with injuries to the head/face that would prohibit wearing of headsets\n* Patients with loss of consciousness, altered mental status, life-threatening injuries/illness or multi-trauma\n* Patients with open skin, lice, scabies, or other infectious skin conditions on the head/face\n* Patients with a history of or current symptoms of vertigo\n* Patients who are blind\n* Patients with significant developmental or cognitive delays who may not be able to engage with or tolerate the virtual reality environment, as determined by their parent/caregiver\n* Patients on whom the VR headset does not fit appropriately\n* Non-English speaking patients (due to limited availability of non-English study documents and consents)'}, 'identificationModule': {'nctId': 'NCT03583450', 'briefTitle': 'Perioperative Virtual Reality for Pediatric Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Perioperative Virtual Reality for Pediatric Anesthesia: Pediatric Distraction on Induction With Virtual Reality (PEDI-VR)', 'orgStudyIdInfo': {'id': '18-25277'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Perioperative virtual reality headset', 'description': 'Perioperative virtual reality headset with mobile app and routine anesthetic care', 'interventionNames': ['Device: Perioperative virtual reality headset with mobile app']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Routine anesthetic care'}], 'interventions': [{'name': 'Perioperative virtual reality headset with mobile app', 'type': 'DEVICE', 'description': 'Perioperative virtual reality headset with mobile app (Samsung Gear VR headset, ChariotVR software)', 'armGroupLabels': ['Perioperative virtual reality headset']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': "UCSF Benioff Children's Hospital", 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Michael Jung', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSF Medical Center'}, {'name': 'Jina Sinskey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}