Ignite Creation Date:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-26 @ 10:16 PM
Study NCT ID:
NCT05334212
Status:
TERMINATED
Last Update Posted:
2023-02-13
First Post:
2021-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Impact of Surgical Theater's Patient Engagement
Sponsor:
Organization:
Raw JSON
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Before 360VR consult (Visit 1) 2. Immediately after 360VR consult (Visit 1) 3. Post-op 6 weeks (Visit 2) 4. Post op 3 months (Visit 3) 5. Post op 6 month (Visit 4)', 'description': 'Reports on 5 dimensions of health: Mobility, Self-care, Usual activities, Pain/Discomfort, Anxiety/Depression. 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Before 360VR consult (Visit 1) 2. Immediately after 360VR consult (Visit 1) 3. Post-op 6 weeks (Visit 2) 4. Post op 3 months (Visit 3) 5. Post op 6 month (Visit 4)', 'description': 'Reports on 5 dimensions of health: Mobility, Self-care, Usual activities, Pain/Discomfort, Anxiety/Depression. Each score from 1-3 with 1.0 being perfect health.'}, {'measure': 'Change From Baseline Pain Disability Questionnaire (PDQ) at 6 Months After Surgery', 'timeFrame': 'Visits 1, 2, 3, 4 - 1. Before 360VR consult (Visit 1) 2. Immediately after 360VR consult (Visit 1) 3. Post-op 6 weeks (Visit 2) 4. Post op 3 months (Visit 3) 5. Post op 6 month (Visit 4)', 'description': '0-10 Scale to assess how pain affects the ability to function across 15 categories. o 0 (optimal function) to 150 (total disability)'}, {'measure': 'Change in Patient Satisfaction and Understanding With HCHAPS (Hospital Consumer Assessment of Healthcare Providers and Systems) at 6 Months After Surgery', 'timeFrame': 'Visits 1, 2, 3, 4 - 1. Before 360VR consult (Visit 1) 2. Immediately after 360VR consult (Visit 1) 3. Post-op 6 weeks (Visit 2) 4. Post op 3 months (Visit 3) 5. Post op 6 month (Visit 4)', 'description': 'Understanding - before and after consult, Anxiety level - before and after consult, Satisfaction with consult, HCAHPS - Overall rating of hospital, Satisfied = 9 or 10 rating'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Lumbar Spine Surgeries', 'Cervical Spine Surgeries']}, 'referencesModule': {'references': [{'pmid': '31331747', 'type': 'BACKGROUND', 'citation': 'Altieri R, Melcarne A, Junemann C, Zeppa P, Zenga F, Garbossa D, Certo F, Barbagallo G. Inferior Fronto-Occipital fascicle anatomy in brain tumor surgeries: From anatomy lab to surgical theater. J Clin Neurosci. 2019 Oct;68:290-294. doi: 10.1016/j.jocn.2019.07.039. Epub 2019 Jul 19.'}, {'pmid': '24051875', 'type': 'BACKGROUND', 'citation': 'Bambakidis NC, Selman WR, Sloan AE. Surgical rehearsal platform: potential uses in microsurgery. Neurosurgery. 2013 Oct;73 Suppl 1:122-6. doi: 10.1227/NEU.0000000000000099.'}, {'pmid': '29256988', 'type': 'BACKGROUND', 'citation': 'Ehlers JP, Uchida A, Srivastava SK. THE INTEGRATIVE SURGICAL THEATER: Combining Intraoperative Optical Coherence Tomography and 3D Digital Visualization for Vitreoretinal Surgery in the DISCOVER Study. Retina. 2018 Sep;38 Suppl 1(Suppl 1):S88-S96. doi: 10.1097/IAE.0000000000001999.'}]}, 'descriptionModule': {'briefSummary': "To evaluate usefulness of Surgical Theater's Patient Engagement 360VR platform in helping align patient expectations and improve patient satisfaction and understanding in spinal surgery consults.", 'detailedDescription': "Surgical Theater is a company that has developed a platform which can be used to describe and explain spinal surgery to patient before they undergo the procedure. The platform specifically implements data from the patient's own MRI and CT scans, creating a 3d reconstruction that can be seen through a virtual reality lens. This technology was developed to help clarify any concerns patient's may have before surgery, and help them better appreciate what will occur in the OR.\n\nSurgical theater has FDA clearance for patient interaction and engagement. Our study is to take surgical theater into our clinics and, after a patient is defined as a surgical candidate, use surgical theater to provide spatial learning and comprehension through modeling so they better understand their surgical plan. Only the SRP system will be used for this study (Surgical Planner).\n\nThe intervention is showing surgical theater to patients identified for surgery in clinic routinely. Surgical theater will be offered to all patients offered surgery. No other changes in practice will be done."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age range: 18-89.\n2. Patients undergoing elective lumbar or cervical spine surgeries\n3. Those who are receiving Surgical Theater consultation as part of their clinical care\n\nExclusion Criteria:\n\n1. Age \\<18 years\n2. Non-elective surgery due to emergency, trauma\n3. Patients undergoing correction for spinal deformities'}, 'identificationModule': {'nctId': 'NCT05334212', 'acronym': 'ISTPE', 'briefTitle': "Impact of Surgical Theater's Patient Engagement", 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': "Evaluating the Impact of Surgical Theater's Patient Engagement 360VR Platform on Spinal Surgery Patient Expectations and Experiences", 'orgStudyIdInfo': {'id': 'STUDY20210810'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Evaluation of usefulness', 'description': "To evaluate usefulness of Surgical Theater's Patient Engagement 360VR platform in helping align patient expectations and improve patient satisfaction and understanding in spinal surgery consults.", 'interventionNames': ['Device: Surgical Theater']}], 'interventions': [{'name': 'Surgical Theater', 'type': 'DEVICE', 'description': 'The surgical theater platform uses data from MRI and CT scans, creating a 3d image that can be seen by the patient.', 'armGroupLabels': ['Evaluation of usefulness']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44130', 'city': 'Middleburg Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals at Southwest General Medical Center', 'geoPoint': {'lat': 41.36144, 'lon': -81.81291}}], 'overallOfficials': [{'name': 'Gabriel Smith, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}