Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-30 @ 5:46 PM
Study NCT ID:
NCT04548635
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2020-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VR for Burn Dressing Changes at Home
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}, {'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D000073818', 'term': 'Pain, Procedural'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-29', 'studyFirstSubmitDate': '2020-09-01', 'studyFirstSubmitQcDate': '2020-09-08', 'lastUpdatePostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain assessment during dressing changes.', 'timeFrame': '15-30 minutes during daily burn dressing changes for up to 7 days.', 'description': '1-10 rating scale (self-reported and caregiver-reported), 1(min)-10(max), with higher score indicating worse outcome.'}, {'measure': 'Observed VR experience.', 'timeFrame': 'Daily for 15-30 minutes burn dressing change for up to 7 days.', 'description': "caregiver-reported subject's engagement with VR (VR-PAT arm only) using a 5-item parent questionnaire."}, {'measure': 'Self-reported VR experience.', 'timeFrame': 'Daily for 15-30 minutes burn dressing change for up to 7 days.', 'description': '1-10 rating scale of degree of realism, pleasure, and satisfaction with VR (VR-PAT arm only), with higher score meaning better outcome.'}], 'secondaryOutcomes': [{'measure': 'Burn-related medications', 'timeFrame': 'Daily for burn dressing change for up to 7 days.', 'description': 'caregiver-reported name and dosage of medication provided for burn-related pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Virtual Reality', 'VR', 'Burns', 'Pain', 'Dressing Changes'], 'conditions': ['Burns', 'Acute Pain', 'Procedural Pain']}, 'referencesModule': {'references': [{'pmid': '35982492', 'type': 'RESULT', 'citation': 'Armstrong M, Lun J, Groner JI, Thakkar RK, Fabia R, Noffsinger D, Ni A, Keesari R, Xiang H. Mobile phone virtual reality game for pediatric home burn dressing pain management: a randomized feasibility clinical trial. Pilot Feasibility Stud. 2022 Aug 18;8(1):186. doi: 10.1186/s40814-022-01150-9.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the impact of our smartphone-based Virtual Reality Pain Alleviation Tool (VR-PAT) during the repeated at-home burn dressing changes of children (5-17 years) with a burn injury in comparison with a control group of children with a burn injury who will not use VR-PAT during at-home burn dressing changes. We hypothesize that children using VR-PAT will report less pain during their dressing changes.', 'detailedDescription': 'Subjects will be randomly assigned to either the VR-PAT intervention group or Control group. Subjects and caregivers in both groups will perform daily dressing changes (as prescribed by their physician) and afterward will answer questions about their pain and any medications used. Subjects and caregivers in the intervention group will answer additional questions about their experience using the VR-PAT, ease of use, and helpfulness. Surveys will be repeated with each dressing changes for one week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pediatric patients age 5-17 years (inclusive)\n* receiving first outpatient dressing change or being discharged from the inpatient burn unit at our institution\n* have a dressing that requires daily changes at home for at least one week\n* can communicate orally\n\nExclusion Criteria:\n\n* any wounds that may interfere with study procedures (i.e. face)\n* vision, hearing, or cognitive/motor impairments preventing valid administration of study measures\n* history of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras\n* minors in foster care\n* suspected child abuse\n* unable to communicate in English\n* families who do not have access to a smartphone (due to the VR-PAT game requirements)'}, 'identificationModule': {'nctId': 'NCT04548635', 'briefTitle': 'VR for Burn Dressing Changes at Home', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'officialTitle': 'Mobile Phone Virtual Reality Game for Pediatric Home Burn Dressing Pain Management', 'orgStudyIdInfo': {'id': 'STUDY00000450'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VR-PAT', 'description': 'Virtual Reality administered during burn dressing changes', 'interventionNames': ['Device: VR-PAT']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Dressing changes performed without Virtual Reality (other distraction methods available in the home allowed).'}], 'interventions': [{'name': 'VR-PAT', 'type': 'DEVICE', 'otherNames': ['Virtual Reality'], 'description': 'Smartphone-based Virtual Reality Pain Alleviation Tool (VR-PAT) via a lightweight, mobile VR headset', 'armGroupLabels': ['VR-PAT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Henry Xiang, MD, MPH, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Nationwide Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nationwide Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Ohio Department of Public Safety', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Center Director', 'investigatorFullName': 'Henry Xiang', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}