Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2026-01-28 @ 12:09 PM
Study NCT ID:
NCT02427659
Status:
COMPLETED
Last Update Posted:
2019-03-13
First Post:
2015-03-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VR High Tech Pain Control Burn Wound Care
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': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-11', 'studyFirstSubmitDate': '2015-03-31', 'studyFirstSubmitQcDate': '2015-04-27', 'lastUpdatePostDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '"Pain" as measured by McGill Short Form Pain Questionnaire', 'timeFrame': 'up to an hour', 'description': 'Pain is being measured'}, {'measure': '"Pain" as measured by Nurse Graphic Rating Scale', 'timeFrame': 'up to 3 hours', 'description': 'Pain is being measured.'}, {'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', 'Virtual Reality as Distraction during Procedure', 'Burn Wound Care'], 'conditions': ['Pain', 'Burn']}, 'descriptionModule': {'briefSummary': 'Using virtual reality as a form of distraction for pain during wound care. Virtual reality involves looking into a set of goggles and then moving through a computer-simulated world.', 'detailedDescription': 'This study has three different groups. Patients will be randomly assigned to one of three groups (two treatments and one control). Treatment for Group 1 is Virtual Reality Distraction during wound care. Group 2 will listen to an audio recording called "Sounds of Nature". Group 3 will be the control group.\n\nSubjects in all three groups will receive the following questionnaires:\n\nGraphic Rating Scale McGill Short-Form pain questionnaire Sullivan Catastrophization scale (only on Day 1/Baseline) The Nurse GRS'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 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': 'NCT02427659', 'acronym': 'VRH2O', 'briefTitle': 'VR High Tech Pain Control Burn Wound Care', 'organization': {'class': 'NIH', 'fullName': 'National Institute of General Medical Sciences (NIGMS)'}, 'officialTitle': 'High Technology Pain Control During Burn Wound Care', 'orgStudyIdInfo': {'id': '41673'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Virtual Reality Distraction', 'description': 'The subjects will receive a 20-minute Virtual Reality Distraction (VRD) during their wound care procedure. The nurse will be doing their wound care.', 'interventionNames': ['Behavioral: Virtual Reality Distraction']}, {'type': 'OTHER', 'label': 'Audio (sounds of nature)', 'description': 'The subjects will listen to an audio recording called "Sounds of Nature" during their wound care. The nurse will be doing the wound care.', 'interventionNames': ['Behavioral: Audio (sound 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 Distraction', 'type': 'BEHAVIORAL', 'otherNames': ['VRD'], 'description': 'The subjects will receive a 20-minute Virtual Reality Distraction (VRD) during their wound care procedure. The nurse will be doing their wound care.', 'armGroupLabels': ['Virtual Reality Distraction']}, {'name': 'Audio (sound of nature)', 'type': 'BEHAVIORAL', 'description': 'The subjects will listen to an audio recording called "Sounds of Nature" during their wound care.', 'armGroupLabels': ['Audio (sounds 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': 'University of Washington; Harborview Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'David R. Patterson, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University fo Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of General Medical Sciences (NIGMS)', 'class': 'NIH'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'David R. Patterson', 'investigatorAffiliation': 'National Institute of General Medical Sciences (NIGMS)'}}}}