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Clinical Trials/NCT05496803
NCT05496803
Unknown
N/A

Chung Shan Medical University Hospital

Chung Shan Medical University Hospital1 site in 1 country100 target enrollmentJuly 27, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Educational Videos
Sponsor
Chung Shan Medical University Hospital
Enrollment
100
Locations
1
Primary Endpoint
The change of parental uncertainty
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

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. Background: Parents experience uncertainty and anxiety when their children undergo conditions mentioned above. Design: 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.

Registry
clinicaltrials.gov
Start Date
July 27, 2022
End Date
July 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Chung Shan Medical University Hospital

Department of pediatrics

Chung Shan Medical University

Eligibility Criteria

Inclusion Criteria

  • Parents whose children underwent first elective cardiac catheterization for congenital heart disease
  • Parents should have been the primary caregivers
  • Parents able to communicate effectively, either orally or in writing

Exclusion Criteria

  • Parents of children with genetic disorders
  • Parents of children with non-cardiac congenital anomalies
  • Parents of children with diseases such as cerebral palsy, epilepsy, psychiatric diseases, and chronic lung diseases

Outcomes

Primary Outcomes

The change of parental uncertainty

Time Frame: day 1 (baseline, before education), day 1 (after education), day 2-5 (discharge day)

The scores of parental uncertainty between "routine education" and "routine plus DVD education" groups. parent's perception uncertainty in illness score was used to evaluate the number scores of anxiety.

The change of parental anxiety 1

Time Frame: day 1 (baseline, before education), day 1 (after education), day 2-5 (discharge day)

The number scores of parental anxiety between "routine education" and "routine plus DVD education" groups. State Anxiety Inventory was used to evaluate the number scores of anxiety.

The change of parental anxiety 2

Time Frame: day 1 (baseline, before education), day 1 (after education), day 2-5 (discharge day)

The number scores of parental anxiety between "routine education" and "routine plus DVD education" groups. Beck Anxiety Inventory was used to evaluate the number scores of anxiety.

Study Sites (1)

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