Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-28 @ 7:33 PM
Study NCT ID:
NCT01471769
Status:
COMPLETED
Last Update Posted:
2012-12-19
First Post:
2011-07-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Video Education Intervention in the Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-17', 'studyFirstSubmitDate': '2011-07-20', 'studyFirstSubmitQcDate': '2011-11-10', 'lastUpdatePostDateStruct': {'date': '2012-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in parent knowledge from baseline', 'timeFrame': 'on day 0 in the ED', 'description': 'A parent knowledge test will be completed by parents prior to the video intervention, immediately after the video intervention, and on day 3 after the video intervention.'}], 'secondaryOutcomes': [{'measure': 'Change in anxiety from baseline', 'timeFrame': 'on day 0 in the ED', 'description': "Parent's anxiety will be measured using a validated pain scale before and immediately after the video intervention"}, {'measure': 'Pain medication use', 'timeFrame': 'assessed on day 0, 1, 2, 3', 'description': 'Pain medicatin use collected in a diary at-home after ED treatment'}, {'measure': "Child's pain", 'timeFrame': 'on day 0, 1, 2, 3', 'description': "child's reported pain at-home after ED treatment"}, {'measure': 'satisfaction', 'timeFrame': 'on day 1, 2, and 3', 'description': 'child and parent at-home satisfaction utilizing a validated likert scale will be assesed on day 1, 2, and 3 after ED treatment to determine if the intervention results in improved satisfaction with pain treatment after discharge home'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pediatric', 'pain'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate if an educational video viewed during the Emergency Department visit will improve parent knowledge of pain management, reduce parent anxiety, and change their use of analgesics at-home after discharge from the Emergency Department.', 'detailedDescription': "This study will investigate the use of a video instruction for parents just prior to discharge on pain treatment for their child. The investigators plan to investigate the effect of the video on knowledge because educational modules in the form of videotapes have been shown to be an effective method to improve a parent's knowledge about pain management prior to surgical procedures. Because parental anxiety has a significant impact on a child's experience of pain and video education has been shown to reduce parent anxiety before a procedure, the investigators will also evaluate if parental anxiety is reduced. Whether or not a short video will change the behavior of parents or their satisfaction with the outcome at home has not been investigated and will be an exploratory hypothesis for this study. This research will be a first step towards optimizing the outpatient care for common diagnoses in the Emergency Department."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* complaint of pain or injury and laceration, fracture or spring, contusion, crush injuries, head injury, motor vehicle collision, or burn.\n\nExclusion Criteria:\n\n* non- English speaking parents\n* primary caregiver not with child in Emergency Department'}, 'identificationModule': {'nctId': 'NCT01471769', 'briefTitle': 'Video Education Intervention in the Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'Video Education Intervention in the Emergency Department', 'orgStudyIdInfo': {'id': 'CHW 10/156'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pain management video', 'description': 'Experimental', 'interventionNames': ['Behavioral: Pain management video']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'falls prevention video', 'description': 'placebo', 'interventionNames': ['Behavioral: Falls Prevention Video']}], 'interventions': [{'name': 'Pain management video', 'type': 'BEHAVIORAL', 'description': '6-minute video', 'armGroupLabels': ['pain management video']}, {'name': 'Falls Prevention Video', 'type': 'BEHAVIORAL', 'otherNames': ['Fall Prevention Video'], 'description': '6-minute video', 'armGroupLabels': ['falls prevention video']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53201', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Children's Hospital of Wisconsin", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Amy L Drendel, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College of Wisconsin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator: Assistant Professor, DO, MS', 'investigatorFullName': 'Amy Drendel', 'investigatorAffiliation': 'Medical College of Wisconsin'}}}}