Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-29 @ 1:43 PM
Study NCT ID:
NCT04923568
Status:
COMPLETED
Last Update Posted:
2023-09-29
First Post:
2021-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VR and Chronic Pain Pilot Usability Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-10-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-27', 'studyFirstSubmitDate': '2021-06-08', 'studyFirstSubmitQcDate': '2021-06-10', 'lastUpdatePostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '% of participants contacted that are enrolled', 'timeFrame': 'at study 1 day visit', 'description': 'We will determine feasibility by measuring the % of participants that are contacted who are enrolled.'}], 'secondaryOutcomes': [{'measure': 'Satisfaction with VR experience', 'timeFrame': 'at study 1 day visit', 'description': "We use the Global Impression of Change Scale, which is a 7 point Likert type scale, at the conclusion of the VR experience to measure patient's perceived impression of change before and after VR."}, {'measure': 'Change in Mood', 'timeFrame': 'at study 1 day visit', 'description': 'We use the Brief Mood Introspection Scale, a 16-item scale, to measure change in mood before and after VR'}, {'measure': 'Change in Pain intensity', 'timeFrame': 'at study 1 day visit', 'description': 'We use a 1-item pain intensity score (0-10) both before and after VR'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': 'This is a pilot feasibility and usability study of a virtual reality device for patients with chronic pain.', 'detailedDescription': 'The investigators will conduct a study of patients with chronic pain to identify interest in participating in a large VR trial and, for those willing to join the team to test the device in person, to pilot 2 sessions of VR to assess usability and collect preliminary data on pain and mood and to obtain data on patient satisfaction with device use. Researchers expect the entire session to last 45 minutes to 1 hour.\n\nAll patients recruited will be in the active arm; this is not a randomized pilot study.\n\nThe intervention being piloted is the EaseVRx - AppliedVR, Los Angeles, CA - VR hardware and software. EaseVRx incorporates evidence-based principles of cognitive behavioral therapy, mindfulness, and pain neuroscience education into an immersive and enhanced biofeedback experience. EaseVRx includes breathing training and relaxation response exercises that activate the parasympathetic nervous system. EaseVRx was designed for at-home use and comes with a sequence of daily immersive experiences, with each VR experience being 2-16 minutes in length (average of 6 minutes). For this pilot, researchers will be doing one in-person session, using two interoceptive VR experiences (out of 56 total).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Chronic pain (using self-report) with pain intensity \\>=4 and confirmed by ICD-10 codes in medical record\n3. Fluency in English\n\nExclusion Criteria:\n\n1. Inability to give informed consent\n2. Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines\n3. Medical condition predisposing to nausea or dizziness\n4. Hypersensitivity to flashing light or motion\n5. No stereoscopic vision or severe hearing impairment\n6. Injury to eyes, face, or neck that prevents use of VR headset\n7. Currently pregnant, by self-report'}, 'identificationModule': {'nctId': 'NCT04923568', 'briefTitle': 'VR and Chronic Pain Pilot Usability Study', 'organization': {'class': 'OTHER', 'fullName': 'Albert Einstein College of Medicine'}, 'officialTitle': 'Virtual Reality and Chronic Pain Pilot Usability Study', 'orgStudyIdInfo': {'id': '2021-13108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EaseVRx sessions', 'description': 'This is a study of patients with chronic pain to identify interest in participating in a large VR trial and, for those willing to join us to test the device in person, to pilot 2 sessions of VR to assess usability and collect preliminary data on pain and mood and to obtain data on patient satisfaction with device use. The entire session will last 45 minutes to 1 hour. All patients recruited will be in the active arm; this is not a randomized pilot study.', 'interventionNames': ['Device: EaseVRx']}], 'interventions': [{'name': 'EaseVRx', 'type': 'DEVICE', 'description': 'Participants will experience 2 sessions of the EaseVRx device for chronic pain', 'armGroupLabels': ['EaseVRx sessions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Hector R Perez, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albert Einstein College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}