Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-26 @ 3:24 AM
Study NCT ID:
NCT06072950
Status:
COMPLETED
Last Update Posted:
2023-10-10
First Post:
2023-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Opioid Use and Predicting Factors at the Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-03', 'studyFirstSubmitDate': '2023-09-18', 'studyFirstSubmitQcDate': '2023-10-03', 'lastUpdatePostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid use', 'timeFrame': 'throughout study participation, up to 8 hours', 'description': 'Opioids use of patients during their stay at Emergency Department (yes/no)'}], 'secondaryOutcomes': [{'measure': 'Oral morphine equivalent', 'timeFrame': 'throughout study participation, up to 8 hours', 'description': 'Doses of opioids received by a patient during their stay at the ED converted to Oral morphine equivalent (OME)'}, {'measure': 'Administered analgesics', 'timeFrame': 'throughout study participation, up to 8 hours', 'description': 'Type and dose of all administered analgesics at Emergency Department.'}, {'measure': 'Pain acceptability', 'timeFrame': 'Asked at moment of admittance and at discharge, up to 6 hours after inclusion', 'description': 'Patient opinion on acceptability of their pain at rest upon admittance and discharge'}, {'measure': 'Reason why patients finds pain acceptable', 'timeFrame': 'Assessed upon admittance', 'description': 'Open question'}, {'measure': 'Patients desire for analgesics', 'timeFrame': 'Asked at moment of admittance and at discharge, up to 6 hours after inclusion', 'description': 'yes/no question whether patient desires analgesics'}, {'measure': 'Patients openness to VR', 'timeFrame': 'Assessed upon admittance', 'description': 'yes/no question to explore patients willingeness to use VR in their situation'}, {'measure': 'Numaric rating score pain scores at rest', 'timeFrame': 'Every 30 minutes until discharge of patient', 'description': 'Including whether this is pre/post analgesics'}, {'measure': 'Numaric rating score anxiety scores', 'timeFrame': 'Every 30 minutes until discharge of patient', 'description': 'NRS anxiety scores'}, {'measure': 'Satisfaction with pain management', 'timeFrame': 'Asked at moment of discharge, up to 6 hours after inclusion', 'description': 'On a numaric rating scale'}, {'measure': 'Nurse opinion on patient adequacy of pain reporting', 'timeFrame': 'Assessed upon admittance', 'description': 'Categorical question: understating - adequate - exaggerating'}, {'measure': 'Duration of ED visit', 'timeFrame': 'throughout study participation, up to 8 hours', 'description': 'Duration of ED visit'}, {'measure': 'Analgesics prescriptions', 'timeFrame': 'throughout study participation, up to 8 hours', 'description': 'When patient is discharged home prescribed analgesics are registered.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Emergency Department', 'Pain at rest', 'Opioid use'], 'conditions': ['Pain', 'Pain, Acute']}, 'descriptionModule': {'briefSummary': 'Background: Increasing opioid misuse is a worldwide problem. About 10% of opioid misusers are primarily exposed to opioids at the Emergency Department (ED). This study was conducted to determine the feasibility for a clinical trial investigating the effect of Virtual Reality therapy on opioid consumption at the ED.\n\nMethods: Adult patients were included when primarily seen by the Emergency Physician and presenting with a NRS pain score ≥4. Main objective was to identify the target population and evaluate outcome measures to sustain a trial incorporating the Oral Morphine Equivalent (OME) at the ED as the primary endpoint. Primary outcome was mean OME administered at the ED. Secondary outcomes included NRS pain scores, main symptoms and type of analgesics administered at the ED.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'We aim to include all patients ≥16 years, who are admitted to the ED of the Radboudumc and primarily seen by an ED physician.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient ≥16 years admitted to ED and identified by an Emergency Physician (EP)\n* NRS pain score ≥4\n* Patient is willing and able to comply with the study protocol\n\nExclusion Criteria:\n\n* Patients initially treated by another physician than the EP.\n* EMV \\< 14\n* History of dementia, seizures\n* Severe hearing/visual impairment not corrected\n* Headwounds or damaged skin with which comfortable and hygienic use is not possible.\n* Presentation to ED because of chronic pain (≥3 months) exacerbation\n* Chronic opioids use (≥3 months)'}, 'identificationModule': {'nctId': 'NCT06072950', 'acronym': 'VRxOPUS-1', 'briefTitle': 'Opioid Use and Predicting Factors at the Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Opioid Use and Predicting Factors at the Emergency Department', 'orgStudyIdInfo': {'id': '113728'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient with NRS pain at rest being 4 or higher', 'description': 'Patient with NRS pain at rest being 4 or higher, primarily treated by emergency physician, internist, or surgeon. All patients receive usual care, no interventions are administered.', 'interventionNames': ['Other: Usual care']}], 'interventions': [{'name': 'Usual care', 'type': 'OTHER', 'description': 'Patients received usual care', 'armGroupLabels': ['Patient with NRS pain at rest being 4 or higher']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6525 GA', 'city': 'Nijmegen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Radboud university medical center', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data will be made available upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}