Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT05112302
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-01-17
First Post:
2021-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Virtual Reality As Adjunct to Anesthesia During Orthopedic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D025981', 'term': 'Hip Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2021-10-13', 'studyFirstSubmitQcDate': '2021-11-05', 'lastUpdatePostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of virtual reality on anxiety level', 'timeFrame': 'Up to 2 hours', 'description': "Evaluate patients' satisfaction with using virutal reality and reduction in anxiety during orthopedic procedures"}], 'secondaryOutcomes': [{'measure': 'Impact of virtual reality on pharmacological therapy doses', 'timeFrame': 'Up to 2 hours', 'description': 'Elucidate the impact of VR on pharmacological therapy doses required for proper analgesia and anxiolysis and on reduction of drug side effects in patient using VR during surgeries.'}, {'measure': "Impact of virtual reality on patient's perioperative temperature", 'timeFrame': 'Up to 3 hours', 'description': 'Evaluate if utilizing virtual reality has a positive impact in preventing patient hypothermia intra- and post-operatively.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['virtual reality', 'knee arthroplasty', 'hip arthroplasty'], 'conditions': ['Knee Arthropathy', 'Hip Injuries']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to obtain feedback from patients and orthopedic surgeons who agree to use virtual reality (VR ) as an adjunct to standard of care in orthopedic cases under regional or central neuraxial nerve block. This will serve as a preliminary study for future trials to compare outcomes between VR and standard of care vs standard of care only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing elective orthopedic surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old.\n* Patients scheduled for orthopedic procedure under regional or central neuraxial nerve block (anterior primary hip arthroplasty or primary knee arthroplasty).\n* Subject willing to participate and able to provide informed consent.\n\nExclusion Criteria:\n\n* Age \\< 18 years old.\n* History of motion sickness or blindness.\n* Unable to consent due to cognitive difficulty.\n* Current diagnosis of epilepsy, dementia, or other neurological disease that may prevent use of VR hardware and software.\n\nSensitivity to flashing light or motion.\n\n* Recent stroke.\n* Injury to the eyes, face, neck, or arms that prevents comfortable use of VR hardware or software, or safe use of the hardware (e.g., open wound, sores, or skin rash on face).'}, 'identificationModule': {'nctId': 'NCT05112302', 'briefTitle': 'A Study to Evaluate Virtual Reality As Adjunct to Anesthesia During Orthopedic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Use of Virtual Reality As an Adjunct for Anesthesia During Orthopedic Procedures Under Regional or Central Neuraxial Nerve Block. a Pilot and Feasibility Study', 'orgStudyIdInfo': {'id': '21-005305'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Virtual reality', 'interventionNames': ['Other: Virtual reality']}], 'interventions': [{'name': 'Virtual reality', 'type': 'OTHER', 'description': 'Use of virtual reality goggles during procedure', 'armGroupLabels': ['Virtual reality']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jackson', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic in Florida'}], 'overallOfficials': [{'name': 'Klaus Torp, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Klaus D. Torp', 'investigatorAffiliation': 'Mayo Clinic'}}}}