Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-30 @ 1:04 AM
Study NCT ID:
NCT04357132
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2020-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality for Appendectomy Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '60 participants assigned to one of two groups. VR- Distraction and VR-Biofeedback'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-06', 'studyFirstSubmitDate': '2020-04-17', 'studyFirstSubmitQcDate': '2020-04-21', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect on VR-biofeedback on anxiety', 'timeFrame': 'Before 10 minute VR session.', 'description': 'Anxiety scores will be collected. Anxiety will be rated using a visual analog scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.'}, {'measure': 'Effect on VR-biofeedback on anxiety', 'timeFrame': 'Immediately after VR session.', 'description': 'Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.'}, {'measure': 'Effect on VR-biofeedback on anxiety', 'timeFrame': '15 minutes after VR session.', 'description': 'Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.'}, {'measure': 'Effect on VR-biofeedback on anxiety', 'timeFrame': '30 minutes after VR session.', 'description': 'Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.'}, {'measure': 'Effect of VR-biofeedback on pain', 'timeFrame': 'Postoperatively 24 - 90 hours.', 'description': 'Pain scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable.'}, {'measure': 'Effect of VR-biofeedback on medication use', 'timeFrame': '24-90 hours', 'description': 'Amount of pain medications used will be collected'}, {'measure': 'Effect of VR-distraction on anxiety', 'timeFrame': 'Before 10 minute VR session.', 'description': 'Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.'}, {'measure': 'Effect of VR-distraction on anxiety', 'timeFrame': 'Immediately after 10 minute VR session.', 'description': 'Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.'}, {'measure': 'Effect of VR-distraction on anxiety', 'timeFrame': '15 minutes after 10 minute VR session.', 'description': 'Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.'}, {'measure': 'Effect of VR-distraction on anxiety', 'timeFrame': '30 minutes after 10 minute VR session.', 'description': 'Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.'}, {'measure': 'Effect of VR-distraction on pain', 'timeFrame': 'Postoperatively 24 - 90 hours.', 'description': 'Pain scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable.'}, {'measure': 'Effect of VR-distraction on medication use', 'timeFrame': '24-90 hours', 'description': 'Pain medications used will be collected'}], 'secondaryOutcomes': [{'measure': 'Role of anxiety on changes in pain', 'timeFrame': 'One time prior to study visit', 'description': 'Participants will complete a questionnaire regarding anxiety'}, {'measure': 'Role of pain catastrophizing', 'timeFrame': 'One time prior to study visit', 'description': 'Participants will complete a questionnaire regarding pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Appendix Rupture', 'Pain', 'Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'To determine the impact of VR-Biofeedback and VR-Distraction on pain and medication utilization in children and adolescents undergoing surgery for ruptured appendix.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 8 - 18 years\n* Able to read, understand, and speak English\n* Patients in the immediate postoperative period following laparoscopic appendectomy for ruptured appendix\n\nExclusion Criteria:\n\n* Outside of age range (\\<8 or \\>18 years)\n* History of developmental delays, uncontrolled psychiatric conditions, or neurological conditions (especially epilepsy and/or significant motion sickness/nausea/vomiting)\n* History of vertigo, dizziness, and/or seizure disorders\n* Conditions that would preclude the application of the VR headset, such as craniofacial deformities\n* History of chronic pain, frequent opioid use and/or active cancer therapy'}, 'identificationModule': {'nctId': 'NCT04357132', 'briefTitle': 'Virtual Reality for Appendectomy Pain', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Functional Response to Immersive Virtual Reality in Pediatric Patients Post-Laparoscopic Appedectomy', 'orgStudyIdInfo': {'id': '2020-0258'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'VR-Biofeedback', 'interventionNames': ['Other: VR-Biofeedback']}, {'type': 'OTHER', 'label': 'VR-Distraction', 'interventionNames': ['Other: VR-Distraction']}], 'interventions': [{'name': 'VR-Biofeedback', 'type': 'OTHER', 'description': 'Participants will be instructed to use the Mindful Aurora Application', 'armGroupLabels': ['VR-Biofeedback']}, {'name': 'VR-Distraction', 'type': 'OTHER', 'description': 'Participants will be instructed to use one of four applications', 'armGroupLabels': ['VR-Distraction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Vanessa Olbrecht, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}