Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-25 @ 4:55 PM
Study NCT ID:
NCT05496803
Status:
UNKNOWN
Last Update Posted:
2022-08-11
First Post:
2022-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Systematic Nursing Guidance on the Psychological Effects of Parents of Children With Cardiac Catheterization.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-09', 'studyFirstSubmitDate': '2022-08-03', 'studyFirstSubmitQcDate': '2022-08-09', 'lastUpdatePostDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of parental uncertainty', 'timeFrame': 'day 1 (baseline, before education), day 1 (after education), day 2-5 (discharge day)', 'description': 'The scores of parental uncertainty between "routine education" and "routine plus DVD education" groups.\n\nparent\'s perception uncertainty in illness score was used to evaluate the number scores of anxiety.'}, {'measure': 'The change of parental anxiety 1', 'timeFrame': 'day 1 (baseline, before education), day 1 (after education), day 2-5 (discharge day)', 'description': 'The number scores of parental anxiety between "routine education" and "routine plus DVD education" groups.\n\nState Anxiety Inventory was used to evaluate the number scores of anxiety.'}, {'measure': 'The change of parental anxiety 2', 'timeFrame': 'day 1 (baseline, before education), day 1 (after education), day 2-5 (discharge day)', 'description': 'The number scores of parental anxiety between "routine education" and "routine plus DVD education" groups.\n\nBeck Anxiety Inventory was used to evaluate the number scores of anxiety.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Educational Videos', 'Catheterization', 'Congenital Heart Disease in Children', 'Parental Uncertainty', 'Parental Anxiety']}, 'descriptionModule': {'briefSummary': 'To examine if adding educational digital video disk to routine education can reduce parental uncertainty and anxiety more if their children undergo congenital heart disease catheterization and when catheterization or post- catheterization complications occur. We want to know, compared to only routine education, if adding digital video disk could decrease parental uncertainty or anxiety more or not.', 'detailedDescription': 'Aims and objectives: To examine if adding educational digital video disk to routine education can reduce parental uncertainty and anxiety more if their children undergo congenital heart disease catheterization and when catheterization or post- catheterization complications occur.\n\nBackground: Parents experience uncertainty and anxiety when their children undergo conditions mentioned above.\n\nDesign: A randomized control-group pretest-posttest design. Methods: In a teaching hospital, 50 fathers and 50 mothers whose children (n=50) underwent first elective catheterization for congenital heart disease were randomly divided into group 1: 25 fathers and 25 mothers receiving routine education plus digital video disk before catheterization; and group 2: 25 fathers and 25 mothers receiving routine education before catheterization. Between groups, parental uncertainty and anxiety levels were compared (1) before education, (2) after education (before catheterization) and (3) on the discharge day (after catheterization). Among mothers whose children had catheterization or post- catheterization complications, the effect of watching the digital video disk on uncertainty and anxiety at discharge day was evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '48 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parents whose children underwent first elective cardiac catheterization for congenital heart disease\n* Parents should have been the primary caregivers\n* Parents able to communicate effectively, either orally or in writing\n\nExclusion Criteria:\n\n* Parents of children with genetic disorders\n* Parents of children with non-cardiac congenital anomalies\n* Parents of children with diseases such as cerebral palsy, epilepsy, psychiatric diseases, and chronic lung diseases'}, 'identificationModule': {'nctId': 'NCT05496803', 'briefTitle': 'Impact of Systematic Nursing Guidance on the Psychological Effects of Parents of Children With Cardiac Catheterization.', 'organization': {'class': 'OTHER', 'fullName': 'Chung Shan Medical University'}, 'officialTitle': 'Chung Shan Medical University Hospital', 'orgStudyIdInfo': {'id': 'CS2-22078'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'study group', 'description': 'parents receiving routine education plus digital video disk before catheterization:pre-catheterization educational videos plus routine education', 'interventionNames': ['Other: routine education plus digital video disk']}, {'type': 'OTHER', 'label': 'control group', 'description': 'parents receiving routine education: pre-catheterization routine education', 'interventionNames': ['Other: routine education']}], 'interventions': [{'name': 'routine education plus digital video disk', 'type': 'OTHER', 'description': 'Parents receiving routine education plus digital video disk before their children receiving congenital heart disease catheterization. The DVD content was the same as the routine education but was presented audio-visually, and the video was easy to understand by the general public.', 'armGroupLabels': ['study group']}, {'name': 'routine education', 'type': 'OTHER', 'description': 'Parents receiving routine education before their children receiving congenital heart disease catheterization', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Shu-Juan Liu', 'role': 'CONTACT'}], 'facility': 'Chung Shan Medical University Hospital.', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Shu-Juan Liu', 'role': 'CONTACT', 'email': 'juan012599@gmail.com', 'phone': '+886 4 24739595#220801'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung Shan Medical University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Department of pediatrics', 'investigatorFullName': 'Chung Shan Medical University Hospital', 'investigatorAffiliation': 'Chung Shan Medical University'}}}}