Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-03 @ 8:19 PM
Study NCT ID:
NCT01099657
Status:
COMPLETED
Last Update Posted:
2017-05-12
First Post:
2010-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality Hypnosis for Chronic Pain Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-10', 'studyFirstSubmitDate': '2010-04-01', 'studyFirstSubmitQcDate': '2010-04-06', 'lastUpdatePostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain and anxiety', 'timeFrame': 'pre and post VR and then up to one month', 'description': 'The subjects will answer questions regarding pain and anxiety at the time of their clinic visit, before and after experiencing virtual reality. Then the subject will be followed for up to one month.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Burns']}, 'descriptionModule': {'briefSummary': 'We would like to determine how well hypnosis works when induced through virtual reality medium for patients who have suffered a major burn injury in the past two years and suffer from chronic pain. These patients are coming back to the outpatient burn and plastic clinic at Harborview Medical Center for routine follow-up. We think that patients will find VR-Hypnosis interesting, and it will help them relax and feel less pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 13 - 75 years\n* Able to complete subjective evaluations of pain\n* English-speaking\n* Able to communicate orally\n\nExclusion Criteria:\n\n* Age less than 13 years or greater than 75 years\n* Incapable of indicating subjective evaluation of pain\n* Non-English-speaking (Virtual Reality Hypnosis only available in English)\n* Demonstrating delirium, psychosis, or Organic Brain Disorder\n* Unable to communicate verbally\n* Significant developmental disability\n* Extreme susceptibility to motion sickness\n* Significant head/or neck injury\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT01099657', 'acronym': 'VRHChP', 'briefTitle': 'Virtual Reality Hypnosis for Chronic Pain Reduction', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Virtual Reality Hypnosis for Chronic Pain Reduction', 'orgStudyIdInfo': {'id': '31498'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality Hypnosis', 'description': 'Virtual Reality Hypnosis for chronic pain', 'interventionNames': ['Behavioral: Virtual Reality Hypnosis for chronic pain']}, {'type': 'EXPERIMENTAL', 'label': 'Virtual Reality Distraction', 'description': 'Virtual Reality Distraction for Chronic Pain', 'interventionNames': ['Behavioral: Virtual Reality Distraction for Chronic Pain']}], 'interventions': [{'name': 'Virtual Reality Hypnosis for chronic pain', 'type': 'BEHAVIORAL', 'description': 'At the time of their clinic visit,the subject will answer pain and anxiety questionnaires before experiencing Virtual Reality Hypnosis. After VRH, the will again answer Pain and anxiety questionnaires.', 'armGroupLabels': ['Virtual Reality Hypnosis']}, {'name': 'Virtual Reality Distraction for Chronic Pain', 'type': 'BEHAVIORAL', 'description': 'At the time of their clinic visit,the subject will answer pain and anxiety questionnaires before experiencing Virtual Reality Distraction. After VRD, the will again answer Pain and anxiety questionnaires.', 'armGroupLabels': ['Virtual Reality Distraction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Harborview Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of General Medical Sciences (NIGMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Rehabilitative Medicine', 'investigatorFullName': 'Shelley A. Wiechman', 'investigatorAffiliation': 'University of Washington'}}}}