Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-02-22 @ 4:10 AM
Study NCT ID:
NCT03568292
Status:
SUSPENDED
Last Update Posted:
2025-11-17
First Post:
2018-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality in Reducing Pain and Anxiety in Cancer Participants Undergoing Painful Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017410', 'term': 'Practice Guidelines as Topic'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D017408', 'term': 'Guidelines as Topic'}, {'id': 'D011785', 'term': 'Quality Assurance, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'whyStopped': 'Awaiting new cohort to open', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2018-06-14', 'studyFirstSubmitQcDate': '2018-06-14', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain as assessed according to a visual analog scale (VAS)', 'timeFrame': 'Up to 1 year', 'description': "A visual analogue pain scale is a validated pain measure. A 10 centimeter horizontal line with a 0 (no pain) on the far left and 10 (worst possible pain) on the far right. Participants rate pain intensity by drawing a mark on the line. Pain intensity is obtained by measuring from the 0 to the participant's mark on the line, yielding a score from 0 to 10."}, {'measure': 'Anxiety', 'timeFrame': 'Up to 1 year', 'description': 'Will be assessed by the State-Trait Anxiety Inventory.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Malignant Neoplasm']}, 'descriptionModule': {'briefSummary': 'This trial studies how well virtual reality (VR) works in reducing pain and anxiety in cancer participants undergoing bone marrow biopsy or lumbar puncture. Virtual reality may impact pain and anxiety during and after the procedure.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine the feasibility of VR in patients undergoing procedural intervention.\n\nSECONDARY OBJECTIVES:\n\nI. To estimate differences between the two arms in terms of pain and anxiety. II. To document any adverse events that could possibly be attributed to the VR intervention.\n\nEXPLORATORY OBJECTIVES:\n\nI. Explore the use of biomarkers as a tool to reflect the impact of intervention.\n\nOUTLINE: Participants are randomized to 1 of 2 arms.\n\nARM I: Participants undergo VR intervention peri-procedure (bone marrow biopsy or lumbar puncture) lasting until completion of the procedure.\n\nARM II: Participants receive standard of care during procedure (bone marrow biopsy or lumbar puncture).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has been diagnosed with any cancer\n* Patient is currently hospitalized and receiving treatment for a primary or secondary cancer at University of Southern California (USC) Norris Comprehensive Cancer Center and Hospital\n* Patient is undergoing a bone marrow biopsy or lumbar puncture\n\nExclusion Criteria:\n\n* Inability to sign informed assent and/or consent\n* Patient with an underlying diagnosis of epilepsy, dementia, Parkinson?s disease, primary central nervous system malignancy, brain metastasis, underlying inflammatory or infectious central nervous system disorder, inner ear infection, history of vertigo, baseline visual or hearing impairment, macular degeneration, untreated glaucoma, implantable medical devices or any medical condition that investigator deems contraindicated\n* Patient with an underlying chronic pain disorder, anxiety disorder, depressive disorder, or other psychiatric illness unspecified\n* Patient with active Clostridium difficile infection\n* Patient on any acute (within last \\< 24 hour \\[hr\\]) or chronic pain medication (opioid, nonsteroidal anti-inflammatory drug \\[NSAID\\], steroid)\n* Patient on chronic steroids \\> 10 mg prednisone equivalent daily or other immunosuppressant \\> 1 week\n* Patient who is post bone marrow transplant\n* Patient with a body mass index (BMI) \\> 35'}, 'identificationModule': {'nctId': 'NCT03568292', 'briefTitle': 'Virtual Reality in Reducing Pain and Anxiety in Cancer Participants Undergoing Painful Procedures', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Effects of Virtual Reality on Pain and Anxiety in Cancer Patients Undergoing Painful Procedures', 'orgStudyIdInfo': {'id': '0S-17-10'}, 'secondaryIdInfos': [{'id': 'NCI-2018-00759', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '0S-17-10', 'type': 'OTHER', 'domain': 'USC / Norris Comprehensive Cancer Center'}, {'id': 'P30CA014089', 'link': 'https://reporter.nih.gov/quickSearch/P30CA014089', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I: Virtual Reality', 'description': 'Participants receive the VR intervention during bone marrow biopsy or lumbar puncture lasting until completion of the procedure. Participants will be trained to use VR equipment prior to the bone marrow biopsy or lumbar puncture. The headset will cover both eyes with a strap along the back to hold the headset in place. The headset will be attached by a wire to a laptop which will power the headset and provide content. A remote control will be available for assistance in setting up or stopping the content in the case of an event. The VR content will consist of meditation and relaxing techniques through visual and auditory input which can last up to one hour. There will be minimal stimulatory effort to decrease excess movement for the procedure.', 'interventionNames': ['Other: Laboratory Biomarker Analysis', 'Device: Oculus Rift Headset', 'Other: Questionnaire Administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm II: No Virtual Reality', 'description': 'Participants receive standard of care during bone marrow biopsy or lumbar puncture.', 'interventionNames': ['Other: Best Practice', 'Other: Laboratory Biomarker Analysis', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Best Practice', 'type': 'OTHER', 'otherNames': ['standard of care', 'standard therapy'], 'description': 'Receive standard of care', 'armGroupLabels': ['Arm II: No Virtual Reality']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I: Virtual Reality', 'Arm II: No Virtual Reality']}, {'name': 'Oculus Rift Headset', 'type': 'DEVICE', 'description': 'Subject wears headset for virtual reality intervention during bone marrow biopsy or lumbar puncture procedure', 'armGroupLabels': ['Arm I: Virtual Reality']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I: Virtual Reality', 'Arm II: No Virtual Reality']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC / Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Jacek Pinski, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Virtually Strong, LLC', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}