Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2025-12-25 @ 2:00 PM
Study NCT ID:
NCT03894592
Status:
UNKNOWN
Last Update Posted:
2019-07-26
First Post:
2018-10-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Virtual Reality Analgesia In Trauma Rehab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059352', 'term': 'Musculoskeletal Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D000081084', 'term': 'Accidental Injuries'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Sequentially Numbered opaque sealed envelopes ( SNOSE) and an online randomization tool'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a Randomized control study. The pre and post VAS scores will be rated by the patient. Randomization will be achieved using Sequentially Numbered opaque sealed envelopes ( SNOSE) and an online randomization tool. All the patients will choose one of three virtual reality experiences.\n\n1. Passive VR Movie\n2. Interactive relaxation/exploration\n3. Active/Adventure experience'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-24', 'studyFirstSubmitDate': '2018-10-29', 'studyFirstSubmitQcDate': '2019-03-26', 'lastUpdatePostDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain perception', 'timeFrame': '1 year', 'description': 'will be measured using the Visual Analogue Scale (VAS) for all subjects pre-, during and post-intervention via self-report. The scale values range from 0 to 10. ) being no pain and 10 being the worst pain'}], 'secondaryOutcomes': [{'measure': 'Increase or decrease in opioid/oral pain medication use', 'timeFrame': '1 year', 'description': 'Number of opioids/oral pain medication consumed will be analyzed from the patients electronic medical record'}, {'measure': 'Heart Rate', 'timeFrame': '1 year', 'description': 'Pre and post intervention heart rate will be monitored using regular hospital equipment to note any changes pre and post intervention.'}, {'measure': 'Patient reported anxiety', 'timeFrame': '1 year', 'description': 'Anxiety will be measured on the Short STAI (State-Trait Anxiety Index) anxiety scale pre- and post-intervention.\n\nThe scale has 2 parts with 20 questions in each part. Each question is rated on a 4 point scale,1 to 4.\n\nTotal scores range from 20 to 80 for each part, with higher score indicating higher anxiety'}, {'measure': 'Blood Pressure', 'timeFrame': '1 year', 'description': 'Pre and post intervention blood pressure will be monitored using regular hospital equipment to note any changes pre and post intervention.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Virtual Reality', 'Musculoskeletal Pain', 'Opioid Use', 'Anxiety', 'Virtual Reality Analgesia', 'Trauma Injury']}, 'descriptionModule': {'briefSummary': 'This will be a pilot study utilizing Virtual Reality Analgesia (VRA) as a first line nonpharmacologic analgesic intervention on the Acute Rehabilitation Unit. In order to assess the efficacy of the intervention with a set of outcome measures will be defined:\n\n* Pain will be measured using the VAS for all subjects pre-, during and post-intervention via self-report.\n* Number of opioids/oral pain medication consumed will be analyzed\n* Patient anxiety will be measured on the Short ( State-Trait Anxiety Index) STAI anxiety scale pre- and post-intervention.\n* Heart rate and blood pressure will also be measured pre and post intervention.', 'detailedDescription': "The purpose of this project is to evaluate the efficacy of virtual reality analgesia (VRA) for Adult patients in acute pain in the Acute Rehabilitation unit. Given the severity of the opioid epidemic, physicians are looking for alternative non-opioid/non-pharmacologic interventions to decrease both pain, and the need for opioids.\n\nThe recognition of pain by an individual requires both a noxious stimulus as well as attention on the part of the subject. Studies have shown that pain sensation is less on the visual analogue scale (VAS) when subjects are distracted, and that distraction can assist in pain control, since humans have limited attention capacity. When treating Adult patients with acute pain, it could thus be useful to have an effective method of pain distraction to improve tolerance and comfort, and to decrease the amount of narcotic medications prescribed.\n\nVirtual reality (VR) is a digital simulation of a three-dimensional environment in which the user is capable of interacting with the generated world via computerized equipment such as gloves or a virtual reality head-mounted display (VRHMD). 360-degree VR video is a subset of virtual reality which creates an immersive experience of real world environments, allowing the user to have a sense of presence and exploration while wearing a (VRHMD). VR exposure is shown to be a potent distractor and has been repeatedly shown to provide analgesia during painful procedures. Since adults are often very attracted to technology, computer games, and virtual reality, we propose a study to allow adults to interact with a custom virtual reality environment in order to consume a substantial proportion of their attentional resources during acute pain episodes. We hypothesize that immersing the patients in VR will allow these patients to spend less attention on pain and allow for less need for other analgesia i.e. opioids.\n\nVR has been demonstrated as a valid method of analgesia for both adults and pediatrics during painful procedures. To the investigator's knowledge, no one has evaluated the use of VRA to reduce opioid consumption in the Acute Rehab unit. In addition to relieving pain, anxiety, stress, and possibly decreasing general sedation, VRA may also decrease medical costs by decreasing length of stay.\n\nVirtual Reality Analgesia (VRA) has been shown by research to be more effective when more immersive. To accomplish this, various head-sets and technologies have been developed to provide a more enveloping experience. Until recently, virtual reality head-mounted displays (VRHMD) had not been widely accepted due to their poor performance and high cost. But recent developments with the Oculus Rift DK1(DK 1 is a model number) in 2012 changed this paradigm. The now commercially available Oculus Rift is an inexpensive state of the art VRHMD. Using the Oculus Rift can create a high definition and smooth environment that will allow for maximal distraction at a modest price point. Therefore, equipment like the Oculus Rift could be an ideal VRA tool in the clinical setting.\n\nMany corporations such as Samsung, Google, and others have invested both capital and development resources that have advanced virtual reality technologies and made them very inexpensive. With these changes, the investigators are finally at a point where both the hardware and the software needed to produce high quality VRHMD is now available at very low and moderate price points. An example of the lowest cost VRHMD is the Google Cardboard, a simple device that allows anyone with a cellphone to experience VR, for as little as $15.\n\nThe investigators propose a study utilizing the highest quality VRHMD to provide VRA during acute pain related to trauma. It is the investigators' hypothesis that by using VRA, significant decrease in the overall pain and discomfort can be observed resulting in a decrease in consumption of oral opioids."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult with Traumatic injury on the Acute Rehab Unit\n* Adult ages 18-100\n* Adult with intact vision who can attend VR intervention\n* Adult receiving PO Medications\n* Adult with motor control of at least one arm\n\nExclusion Criteria:\n\n* Adult who has uncontrolled seizures more than 4 times per year\n* Adult who is not attentive to VR secondary to poor concentration/poor cognition to external stimuli.\n* Adult with no volitional control of the neck and or upper extremities.'}, 'identificationModule': {'nctId': 'NCT03894592', 'briefTitle': 'Virtual Reality Analgesia In Trauma Rehab', 'organization': {'class': 'OTHER', 'fullName': 'New York City Health and Hospitals Corporation'}, 'officialTitle': 'Utilizing Virtual Reality Analgesia (VRA) as a First Line Nonpharmacologic Analgesic Intervention on the Acute Rehabilitation Unit: A Pilot Study', 'orgStudyIdInfo': {'id': '2018-9196'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Virtual Reality analgesia', 'description': 'Trauma patients in rehab unit in the participating hospital will be included in this arm if they are randomized to receive the intervention which is a virtual reality headset providing immersive interactive content in the video format', 'interventionNames': ['Other: Virtual reality']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Trauma patients in rehab unit in the participating hospital will be included in this arm if they are randomized to receive no intervention'}], 'interventions': [{'name': 'Virtual reality', 'type': 'OTHER', 'description': 'Trauma patients enrolled in the study will be offered Virtual Reality experieince per the protocol', 'armGroupLabels': ['Virtual Reality analgesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stern Michelle, MD', 'role': 'CONTACT', 'email': 'michelle.stern@nychhc.org', 'phone': '917-577-9543'}], 'facility': 'Jacobi Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'centralContacts': [{'name': 'Michelle Stern, MD', 'role': 'CONTACT', 'email': 'Michelle.Stern@nychhc.org', 'phone': '9175779543'}, {'name': 'Ratnakar P Veeramachaneni, MD', 'role': 'CONTACT', 'email': 'rveerama@montefiore.org', 'phone': '7182077551'}], 'overallOfficials': [{'name': 'Michelle Stern, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York City Health and Hospitals Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York City Health and Hospitals Corporation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}