Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2026-01-18 @ 9:14 AM
Study NCT ID:
NCT05344118
Status:
COMPLETED
Last Update Posted:
2024-06-28
First Post:
2022-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Parental Perceptions on Prescription Opioid Use
Sponsor:
Organization:
Raw JSON
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'OG000', 'title': 'Parents', 'description': 'Parents of children undergoing orthopedic surgery\n\nSurvey: REDCap survey'}], 'classes': [{'title': "Don't know", 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'In a locked place', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}, {'title': 'Medicine cabinet', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Out of reach of children', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'In your opinion, what is the most appropriate way to safely store opioids?', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Three of the 125 participants did not answer this question.'}, {'type': 'PRIMARY', 'title': 'Safe Disposal of Opioids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 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to safely dispose of opioids?', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Two of the 125 participants did not answer this question.'}, {'type': 'SECONDARY', 'title': 'Employment Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Parents', 'description': 'Parents of children undergoing orthopedic surgery\n\nSurvey: REDCap survey'}], 'classes': [{'title': 'Employed for wages', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}]}]}, {'title': 'Not working', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Out of work and looking for work', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Self-employed', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Stay at home parent', 'categories': [{'measurements': [{'value': '14', 'groupId': 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'BG000'}]}], 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}]}]}, {'title': 'Single, never married', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}, {'title': 'No answer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Primary Language Spoken at Home', 'classes': [{'title': 'English', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '118', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'No answer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-12', 'size': 321651, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-06-29T15:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-26', 'studyFirstSubmitDate': '2022-04-19', 'resultsFirstSubmitDate': '2023-06-29', 'studyFirstSubmitQcDate': '2022-04-19', 'lastUpdatePostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-26', 'studyFirstPostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comfort With Child Receiving Opioids During Surgery', 'timeFrame': 'Baseline', 'description': 'Are you comfortable with your child receiving opioids (for example: Morphine, Fentanyl, Dilaudid) during surgery?'}, {'measure': 'Comfort With Child Receiving Opioids After Surgery', 'timeFrame': 'Baseline', 'description': 'Are you comfortable with your child receiving opioids (for example: Morphine, Fentanyl, Dilaudid) after surgery?'}, {'measure': 'Danger of Opioids', 'timeFrame': 'Baseline', 'description': 'Do you believe prescription opioids are dangerous?'}, {'measure': 'Opioid Education', 'timeFrame': 'Baseline', 'description': 'How much education have you received about opioids?'}, {'measure': 'Safe Storage of Opioids', 'timeFrame': 'Baseline', 'description': 'In your opinion, what is the most appropriate way to safely store opioids?'}, {'measure': 'Safe Disposal of Opioids', 'timeFrame': 'Baseline', 'description': 'In your opinion, what is the most appropriate way to safely dispose of opioids?'}], 'secondaryOutcomes': [{'measure': 'Employment Status', 'timeFrame': 'Baseline', 'description': 'Current employment status of parent'}, {'measure': 'Education', 'timeFrame': 'Baseline', 'description': 'Level of education of parent'}, {'measure': 'Gender of Child', 'timeFrame': 'Baseline', 'description': "Gender at birth of participant's child undergoing surgery"}, {'measure': 'Age of Child', 'timeFrame': 'Baseline', 'description': "Age of the participant's child undergoing surgery"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Orthopedic Disorder']}, 'descriptionModule': {'briefSummary': 'This study involves an anonymous survey given to parents regarding their perceptions on prescription opioid use for pain control in children undergoing orthopedic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Parents of children scheduled for orthopedic surgery', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Parents of patients between 1-18 years of age scheduled for orthopedic surgery at Nationwide Children's Hospital.\n\nExclusion Criteria:\n\n* Parents with children less than 1 or greater than 18 years of age or scheduled for surgery other than orthopedic.\n* Non-English speaking parents."}, 'identificationModule': {'nctId': 'NCT05344118', 'briefTitle': 'Parental Perceptions on Prescription Opioid Use', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'officialTitle': 'Parental Perceptions on Prescription Opioid Use for Pain Control in Children Undergoing Orthopedic Surgery', 'orgStudyIdInfo': {'id': 'STUDY00002410'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Parents', 'description': 'Parents of children undergoing orthopedic surgery', 'interventionNames': ['Other: Survey']}], 'interventions': [{'name': 'Survey', 'type': 'OTHER', 'description': 'REDCap survey', 'armGroupLabels': ['Parents']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nationwide Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Anesthesiology & Pain Medicine', 'investigatorFullName': 'Joseph D. Tobias', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}