Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2026-01-29 @ 6:21 PM
Study NCT ID:
NCT02729259
Status:
COMPLETED
Last Update Posted:
2020-06-09
First Post:
2016-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
H2O VR for Burns 2015
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-04', 'studyFirstSubmitDate': '2016-03-31', 'studyFirstSubmitQcDate': '2016-04-05', 'lastUpdatePostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '"Pain and anxiety" as measured by Graphic Rating Scale', 'timeFrame': 'up to an hour', 'description': 'Pain and anxiety is being measured'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['VRD'], 'conditions': ['Pain', 'Burn']}, 'descriptionModule': {'briefSummary': 'This study is designed to find additional methods to reduce pain during wound care. In this study the investigators use virtual reality (a form of distraction) in addition to pain medication during a burn wound care.', 'detailedDescription': 'This study will employ a randomized within-subjects design. There are three different conditions in this study. By randomization, the participants will experience at least two of the conditions and likely all three, depending on the number of their wound care sessions. All subjects will always receive all their usual pain medications for all treatment conditions. The three conditions are: High Tech Virtual Reality (VRD), Low Tech Virtual Reality (Nature Slides), and standard wound care (no VR). The subjects will be randomly assigned to receive some portions of their wound care sessions during High Tech Virtual Reality (VRD), some portions during Low Tech Virtual Reality (Nature Slides), and some portions with standard wound care, no virtual reality. The treatment orders will be randomized. After each treatment condition the investigators will ask subjects one pain question about their pain intensity during the most recent treatment condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than or equal to 18 years\n* Compliant and able to complete questionnaires\n* No history of psychiatric disorder\n* Not demonstrating delirium, psychosis or any form of Organic Brain Disorder\n* Able to communicate verbally\n* English-speaking\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Not capable of indicating pain intensity\n* Not capable of filling out study measures\n* Evidence of traumatic brain injury\n* History of psychiatric disorder\n* Demonstrating delirium, psychosis or any form of Organic Brain Disorder and associated memory problems\n* Unable to communicate orally\n* Receiving prophylaxis for alcohol or drug withdrawal\n* Developmental disability\n* Any face/head/neck injuries that interfere with the use of Virtual Reality equipment\n* Non-English Speaking\n* Extreme susceptibility to motion sickness\n* Seizure history'}, 'identificationModule': {'nctId': 'NCT02729259', 'acronym': 'H2OWC', 'briefTitle': 'H2O VR for Burns 2015', 'organization': {'class': 'NIH', 'fullName': 'National Institute of General Medical Sciences (NIGMS)'}, 'officialTitle': 'Water Friendly Virtual Reality for Burns', 'orgStudyIdInfo': {'id': '50416EB/002594'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Virtual Reality Snowworld', 'description': 'The subjects will receive Virtual Reality Distraction (VRD) during their wound care procedure. The nurse will be doing their wound care.', 'interventionNames': ['Behavioral: Virtual Reality Snowworld']}, {'type': 'OTHER', 'label': 'Virtual Reality slides of nature', 'description': 'The subjects will see several slides of the nature through virtual reality goggles during their wound care. The nurse will be doing the wound care.', 'interventionNames': ['Behavioral: Virtual Reality slides of nature']}, {'type': 'OTHER', 'label': 'Control standard nurse wound care', 'description': 'The subjects will receive their standard care during wound care. The nurse will be doing the wound care.', 'interventionNames': ['Behavioral: Control standard nurse wound care']}], 'interventions': [{'name': 'Virtual Reality Snowworld', 'type': 'BEHAVIORAL', 'description': 'The subjects will receive Virtual Reality Snowworld during their wound care procedure. The nurse will be doing their wound care.', 'armGroupLabels': ['Virtual Reality Snowworld']}, {'name': 'Virtual Reality slides of nature', 'type': 'BEHAVIORAL', 'description': 'The subjects will receive Virtual Reality Slides of Nature during their wound care procedure. The nurse will be doing their wound care.', 'armGroupLabels': ['Virtual Reality slides of nature']}, {'name': 'Control standard nurse wound care', 'type': 'BEHAVIORAL', 'description': 'The subjects will receive their standard care during wound care. The nurse will be doing the wound care.', 'armGroupLabels': ['Control standard nurse wound care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Harborview Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'David R. Patterson, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of General Medical Sciences (NIGMS)', 'class': 'NIH'}, 'collaborators': [{'name': 'University of Washington', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'David R. Patterson', 'investigatorAffiliation': 'National Institute of General Medical Sciences (NIGMS)'}}}}