Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT02517658
Status:
COMPLETED
Last Update Posted:
2019-02-19
First Post:
2015-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Adenotonsillectomy Postoperative Parental Teaching Tool
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014743', 'term': 'Videotape Recording'}], 'ancestors': [{'id': 'D013637', 'term': 'Tape Recording'}, {'id': 'D001296', 'term': 'Audiovisual Aids'}, {'id': 'D018961', 'term': 'Educational Technology'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D013690', 'term': 'Television'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'heather.dellinger@nationwidechildrens.org', 'phone': '6147222997', 'title': 'Clinical Research Coordinator', 'organization': "Nationwide Children's Hospital"}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '72 hours post-op.', 'eventGroups': [{'id': 'EG000', 'title': 'Standard Discharge Teaching', 'description': 'Parents will receive standard discharge teaching from the nurse prior to discharge.\n\nStandard discharge teaching: Receiving standard post tonsillectomy discharge instructions from the nurse prior to discharge.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Video w/ Post Exam Immediately After Video', 'description': 'Parents will watch the video and then take the post test immediately after watching the video.\n\nVideo: Watching a YouTube video containing post tonsillectomy discharge instructions.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Video w/ Post Exam After Discharge Teaching', 'description': 'Parents will watch the video but wait to take the post exam until after the discharge instructions are given by the nurse prior to discharge.\n\nVideo: Watching a YouTube video containing post tonsillectomy discharge instructions.\n\nStandard discharge teaching: Receiving standard post tonsillectomy discharge instructions from the nurse prior to discharge.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Difference in Answers to Pre & Post Teaching Questionnaires', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Discharge Teaching', 'description': 'Parents will receive standard discharge teaching from the nurse prior to discharge.\n\nStandard discharge teaching: Receiving standard post tonsillectomy discharge instructions from the nurse prior to discharge.'}, {'id': 'OG001', 'title': 'Video w/ Post Exam Immediately After Video', 'description': 'Parents will watch the video and then take the post test immediately after watching the video.\n\nVideo: Watching a YouTube video containing post tonsillectomy discharge instructions.'}, {'id': 'OG002', 'title': 'Video w/ Post Exam After Discharge Teaching', 'description': 'Parents will watch the video but wait to take the post exam until after the discharge instructions are given by the nurse prior to discharge.\n\nVideo: Watching a YouTube video containing post tonsillectomy discharge instructions.\n\nStandard discharge teaching: Receiving standard post tonsillectomy discharge instructions from the nurse prior to discharge.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'approx. 1 - 2 hrs post-op', 'description': 'Assessing the difference in how parents answered the questionnaire before receiving any discharge instructions and the questionnaire after watching the video or receiving standard discharge instructions by the nurse. Parents completed pre-instruction and post-instruction assessments of their knowledge of post-operative pain management, with responses scored on a 0-8 scale by assigning 1 point to each correct response out of 8 multiple-choice questions. Higher difference score means that the parents answered more questions correctly after the teaching/video.', 'unitOfMeasure': 'difference in testing scores', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Discharge Teaching', 'description': 'Parents will receive standard discharge teaching from the nurse prior to discharge.\n\nStandard discharge teaching: Receiving standard post tonsillectomy discharge instructions from the nurse prior to discharge.'}, {'id': 'FG001', 'title': 'Video w/ Post Exam Immediately After Video', 'description': 'Parents will watch the video and then take the post test immediately after watching the video.\n\nVideo: Watching a YouTube video containing post tonsillectomy discharge instructions.'}, {'id': 'FG002', 'title': 'Video w/ Post Exam After Discharge Teaching', 'description': 'Parents will watch the video but wait to take the post exam until after the discharge instructions are given by the nurse prior to discharge.\n\nVideo: Watching a YouTube video containing post tonsillectomy discharge instructions.\n\nStandard discharge teaching: Receiving standard post tonsillectomy discharge instructions from the nurse prior to discharge.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '99', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Discharge Teaching', 'description': 'Parents will receive standard discharge teaching from the nurse prior to discharge.\n\nStandard discharge teaching: Receiving standard post tonsillectomy discharge instructions from the nurse prior to discharge.'}, {'id': 'BG001', 'title': 'Video w/ Post Exam Immediately After Video', 'description': 'Parents will watch the video and then take the post test immediately after watching the video.\n\nVideo: Watching a YouTube video containing post tonsillectomy discharge instructions.'}, {'id': 'BG002', 'title': 'Video w/ Post Exam After Discharge Teaching', 'description': 'Parents will watch the video but wait to take the post exam until after the discharge instructions are given by the nurse prior to discharge.\n\nVideo: Watching a YouTube video containing post tonsillectomy discharge instructions.\n\nStandard discharge teaching: Receiving standard post tonsillectomy discharge instructions from the nurse prior to discharge.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '99', 'groupId': 'BG003'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '99', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Female, Male data were not collected'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '99', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '99', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-12', 'studyFirstSubmitDate': '2015-08-05', 'resultsFirstSubmitDate': '2017-09-28', 'studyFirstSubmitQcDate': '2015-08-06', 'lastUpdatePostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-12', 'studyFirstPostDateStruct': {'date': '2015-08-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in Answers to Pre & Post Teaching Questionnaires', 'timeFrame': 'approx. 1 - 2 hrs post-op', 'description': 'Assessing the difference in how parents answered the questionnaire before receiving any discharge instructions and the questionnaire after watching the video or receiving standard discharge instructions by the nurse. Parents completed pre-instruction and post-instruction assessments of their knowledge of post-operative pain management, with responses scored on a 0-8 scale by assigning 1 point to each correct response out of 8 multiple-choice questions. Higher difference score means that the parents answered more questions correctly after the teaching/video.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Tonsillectomy']}, 'descriptionModule': {'briefSummary': 'The study will involve parents filling out a survey before \\& after watching a teaching tool video (https://www.youtube.com/watch?v=rIH63jqvlio) in addition to standard post-op teaching. The parents randomized to the video arms will watch the video while their child is in the OR and then either take the post survey immediately after or wait to take the survey until just prior to discharge. Parents not in the video arms of the study will also be asked to complete a survey pre and post standard pain management teaching.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parent or caregiver of any child having either adenotonsillectomy or tonsillectomy.\n\nExclusion Criteria:\n\n* Non-english speaking families that require an interpreter.\n* Any parent/family/caregiver that declines to be part of the study.'}, 'identificationModule': {'nctId': 'NCT02517658', 'briefTitle': 'Adenotonsillectomy Postoperative Parental Teaching Tool', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'orgStudyIdInfo': {'id': 'IRB15-00063'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Discharge Teaching', 'description': 'Parents will receive standard discharge teaching from the nurse prior to discharge.', 'interventionNames': ['Other: Standard discharge teaching']}, {'type': 'EXPERIMENTAL', 'label': 'Video w/ post exam immediately after video', 'description': 'Parents will watch the video and then take the post test immediately after watching the video.', 'interventionNames': ['Other: Video']}, {'type': 'EXPERIMENTAL', 'label': 'Video w/ post exam after discharge teaching', 'description': 'Parents will watch the video but wait to take the post exam until after the discharge instructions are given by the nurse prior to discharge.', 'interventionNames': ['Other: Video', 'Other: Standard discharge teaching']}], 'interventions': [{'name': 'Video', 'type': 'OTHER', 'description': 'Watching a YouTube video containing post tonsillectomy discharge instructions.', 'armGroupLabels': ['Video w/ post exam after discharge teaching', 'Video w/ post exam immediately after video']}, {'name': 'Standard discharge teaching', 'type': 'OTHER', 'description': 'Receiving standard post tonsillectomy discharge instructions from the nurse prior to discharge.', 'armGroupLabels': ['Standard Discharge Teaching', 'Video w/ post exam after discharge teaching']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Sarah Khan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Nationwide Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sarah Khan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor of Anesthesiology', 'investigatorFullName': 'Sarah Khan', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}