Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-28 @ 6:37 AM
Study NCT ID:
NCT03528668
Status:
COMPLETED
Last Update Posted:
2021-02-24
First Post:
2018-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Receptiveness to Using Virtual Reality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-23', 'studyFirstSubmitDate': '2018-04-23', 'studyFirstSubmitQcDate': '2018-05-16', 'lastUpdatePostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain', 'timeFrame': 'Change between baseline and 5 minutes after intervention', 'description': 'Change in subjective report of pain measured on a visual analog scale'}], 'secondaryOutcomes': [{'measure': 'Change in Heart Rate', 'timeFrame': 'Change between baseline and 5 minutes after intervention', 'description': 'Change in heart rate measured in beats per minute'}, {'measure': 'Change in Anxiety', 'timeFrame': 'Change between baseline and 5 minutes after intervention', 'description': 'Change in subjective report of anxiety measured on a visual analog scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the acceptability, use, and general effect that exposure to virtual reality has on hospitalized patients reporting at least one discomfort including recent or current moderate-severe pain.', 'detailedDescription': 'Patients with moderate-severe pain will be approached with approval of nursing staff and front line nurse manager who determine their appropriateness for a trial of virtual reality (VR) exposure for up to 30 minutes. The trial and use of VR will be explained after meeting the inclusion criteria and they will be asked about their level of interest in trying the VR headset. If interested, the subject will indicate their verbal consent to proceed with the VR trial. They will be asked about any baseline discomforts of pain, anxiety/stress or other discomfort; which will be rated on a 0-10 numeric (visual analog) scale. A baseline heart rate will be recorded in beats per minute. The headset will be applied and adjusted for comfort, then the app will be started along with a timer to track the duration of their use up to a maximum of 30 minutes. When the Headset is removed, the duration of use will be noted. The change in post-exposure heart rate (in beats per minute) and discomforts of pain, anxiety/stress or other discomforts (subtracting baseline from 5 minute post-exposure data) will be recorded. Subjects will be asked about the ease of use, whether or not they would use VR again, and for any other comments they would like to express. The headset will be disinfected between patient use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Inpatients on adult general care medical/surgical units, regardless of genders will be identified via an existing pain assessment dashboard that allows the investigator to identify patients with 3 or episodes of moderate-severe pain in the prior 24-hour period. The investigator will scan the report for potential subjects in accordance with participating units, inclusion and exclusion criteria. The front-line nurse manager and registered Nurse caring for to patient will be contacted for appropriateness to consider including and the timing when the patient can be approached without interrupting planned tests, treatments or workflow.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English-speaking\n* Inpatients on a general care unit\n* Current or recorded moderate to severe pain in past 24 hours\n\nExclusion Criteria:\n\n* Receiving palliative/end of life care;\n* Admitted for treatment of psychiatric or mental health disorder\n* History of seizure or stroke\n* Legally blind or deaf\n* Moderate or severe cognitive impairment\n* Head wounds or bandages\n* On isolation precautions.'}, 'identificationModule': {'nctId': 'NCT03528668', 'briefTitle': 'Patient Receptiveness to Using Virtual Reality', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Patient Receptiveness to Using Virtual Reality as a Distractor From Pain', 'orgStudyIdInfo': {'id': '2017P002788'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Virtual Reality Exposure', 'type': 'DEVICE', 'description': 'Exposure to Virtual Reality program for up to 30 minutes'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Paul M Arnstein, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be collected without individual patient identifiers. Patient identifiers will be logged and separately in a locked confidential file.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Nurse Specialist', 'investigatorFullName': 'Paul Arnstein', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}