Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-27 @ 9:48 PM
Study NCT ID:
NCT04464304
Status:
COMPLETED
Last Update Posted:
2021-10-26
First Post:
2020-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality for Postoperative Pain Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D000072836', 'term': 'Surgical Wound'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-25', 'studyFirstSubmitDate': '2020-07-06', 'studyFirstSubmitQcDate': '2020-07-06', 'lastUpdatePostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in patient-reported pain scores', 'timeFrame': 'Up to 4 hours after intervention use', 'description': 'Pain scores will be obtained using an 11-point Numeric Rating Scale (NRS) prior to each intervention, immediately after the intervention, and then hourly up to 4 hours after the intervention to assess changes in pain scores after each intervention. A score of 0 signifies no pain, and a score of 10 signifies the highest severity of pain.'}], 'secondaryOutcomes': [{'measure': 'Opioid usage', 'timeFrame': 'Average 24 hours after intervention use', 'description': 'Opioid use after intervention will be documented, measured in average morphine milligram equivalents (MME).'}, {'measure': 'Patient experience', 'timeFrame': 'Up to 4 hours after intervention use', 'description': 'Patients will complete a short survey at the completion of their participation in the study evaluating their audiovisual experience using a 5-point Likert scale, with responses ranging from "1 = Strongly Disagree" to "5 = Strongly Agree."'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Virtual Reality'], 'conditions': ['Surgery', 'Pain, Postoperative', 'Incision', 'Otolaryngological Disease']}, 'referencesModule': {'references': [{'pmid': '35679057', 'type': 'DERIVED', 'citation': 'Pandrangi VC, Shah SN, Bruening JD, Wax MK, Clayburgh D, Andersen PE, Li RJ. Effect of Virtual Reality on Pain Management and Opioid Use Among Hospitalized Patients After Head and Neck Surgery: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2022 Aug 1;148(8):724-730. doi: 10.1001/jamaoto.2022.1121.'}]}, 'descriptionModule': {'briefSummary': 'This trial studies an active virtual reality (VR) experience as a means for non-pharmacologic postoperative pain management among patients after head and neck surgery. Investigators will assess differences in pain scores, analgesic use, and subjective patient experiences between patients participating in a VR activity and patients participating in the same activity using a smartphone.', 'detailedDescription': 'Management of postoperative pain after head and neck surgery is complex, and has received increased attention to improve patient recovery and quality of life. Narcotic analgesics are frequently utilized in postoperative pain management, but these have risks including nausea, sedation, constipation, and dependence. Multimodal analgesia can reduce narcotic use and improve recovery, but medical comorbidities may contraindicate the use of certain medications. Non-pharmacologic measures for postoperative pain control may provide novel and cost-effective strategies to confront this complex issue.\n\nPatients undergoing head and neck surgery will be randomly allocated to participate in an immersive experience in VR, or to participate in a similar experience on a two-dimensional screen using a smartphone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have undergone head and neck surgery with an average pain score of 3 or greater out of 10 during the 24 hours preceding the screening\n* Are able to provide informed consent\n* Are not in the intensive care unit (ICU)\n\nExclusion Criteria:\n\n* Symptoms concerning for an active respiratory infection including fever, cough, and shortness of breath or confirmed respiratory infection\n* Active eye discharge\n* Active nausea or vomiting\n* History of seizure, epilepsy, or hypersensitivity to flashing light\n* History of motion sickness or vertigo\n* Have wound dressings on the head or neck that prevent comfortable and safe use of the virtual reality headset'}, 'identificationModule': {'nctId': 'NCT04464304', 'briefTitle': 'Virtual Reality for Postoperative Pain Management', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Virtual Reality for Postoperative Pain Management After Head and Neck Surgery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '00020777'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Virtual Reality', 'description': 'Patients will be provided with a commercially-available VR device for use up to 15 minutes at bedside.', 'interventionNames': ['Device: Virtual Reality (Oculus Quest)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Smartphone', 'description': 'Patients will be provided with a commercially-available smartphone device for use up to 15 minutes at bedside.', 'interventionNames': ['Device: Smartphone']}], 'interventions': [{'name': 'Smartphone', 'type': 'DEVICE', 'description': 'Patients will participate in a similar game to the VR cohort, but will use a smartphone device.', 'armGroupLabels': ['Smartphone']}, {'name': 'Virtual Reality (Oculus Quest)', 'type': 'DEVICE', 'description': 'Patients will participate in a game using VR.', 'armGroupLabels': ['Virtual Reality']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Ryan Li, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Otolaryngology - Head and Neck Surgery, Division of Head and Neck Surgery, School of Medicine', 'investigatorFullName': 'Ryan Li, MD', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}