Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-01-02 @ 6:48 AM
Study NCT ID:
NCT06624969
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-03
First Post:
2024-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality in Reducing Acute Orthopedic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2024-09-17', 'studyFirstSubmitQcDate': '2024-10-01', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'opioid use', 'timeFrame': 'From date of enrollment which begins at hospital admission until the date of hospital discharge, assessed up to 5 weeks', 'description': 'Change in opioid equivalents during hospital stay from hospital admission to discharge'}], 'secondaryOutcomes': [{'measure': 'reduction in anxiolytics', 'timeFrame': 'From date of enrollment which begins at hospital admission until the date of hospital discharge, assessed up to 5 weeks', 'description': 'Change in anxiolytics during the hospital admission from admission to discharge'}, {'measure': 'hospital length of stay', 'timeFrame': 'From date of enrollment which begins at hospital admission until the date of hospital discharge, assessed up to 5 weeks'}, {'measure': 'reduction in sleep aids prescribed', 'timeFrame': 'From date of enrollment which begins at hospital admission until the date of hospital discharge, assessed up to 5 weeks', 'description': 'Change in sleep aids prescribed during the hospital stay from hospital admission to discharge'}, {'measure': 'User experiences', 'timeFrame': 'obtained once on the day of hospital discharge, up to 5 weeks from study enrollment', 'description': 'Subjective user experiences with the virtual reality program obtained at hospital discharge using a questionnaire with Likert scale answers showing higher scores to have better experiences with the intervention'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain control', 'orthopedic', 'fracture', 'hospital'], 'conditions': ['Fractures']}, 'descriptionModule': {'briefSummary': "The primary aim of this research is to show that a virtual reality (VR) service line is feasible and can sustain itself with the ability to take care of patients. Additionally, the investigators aim to learn about the limitations of a service line and provide a pathway for future improvements in building a VR service line that is optimally aligned with the user's needs. Secondary aims are to evaluate the clinical aspects of the patient's outcomes including length of stay, morphine equivalents in pain medicine required during the hospital stay, and user experiences."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Hospitalized with an orthopedic fracture\n2. Able to participate fully in all aspects of the study\n3. Able to understand and sign informed consent\n4. Individuals with unaided vision or those who can correct their vision using contact lenses\n\n Exclusion Criteria:\n5. Non-English speaking\n6. Self-reported history of acute and/or chronic severe motion sickness\n7. The presence of a facial/head deformity that will prohibit the wearing of a VR head mounted display.\n8. Legally blind or deaf\n9. Have had a seizure within the past 1 year\n10. Have current (within the past 30 days) clinically significant acute or chronic progressive or unstable/uncontrolled neurologic disorder\n11. Have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence'}, 'identificationModule': {'nctId': 'NCT06624969', 'briefTitle': 'Virtual Reality in Reducing Acute Orthopedic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Virtual Reality in Reducing Acute Orthopedic Pain', 'orgStudyIdInfo': {'id': '24-009261'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual reality', 'description': 'Intervention with virtual reality', 'interventionNames': ['Other: virtual reality']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'No virtual reality intervention'}], 'interventions': [{'name': 'virtual reality', 'type': 'OTHER', 'description': 'Virtual reality program to reduce pain in orthopedic fractures', 'armGroupLabels': ['Virtual reality']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Scott Helgeson, MD', 'role': 'CONTACT', 'email': 'helgeson.scott@mayo.edu', 'phone': '904-953-2000'}], 'overallOfficials': [{'name': 'Scott Helgeson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant, Assistant Professor of Medicine', 'investigatorFullName': 'Scott A. Helgeson', 'investigatorAffiliation': 'Mayo Clinic'}}}}