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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05496803
Other study ID # CS2-22078
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 27, 2022
Est. completion date July 2023

Study information

Verified date August 2022
Source Chung Shan Medical University
Contact Shu-Juan Liu
Phone +886 4 24739595#220801
Email juan012599@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date July 2023
Est. primary completion date July 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 48 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
routine education plus digital video disk
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.
routine education
Parents receiving routine education before their children receiving congenital heart disease catheterization

Locations

Country Name City State
Taiwan Chung Shan Medical University Hospital. Taichung

Sponsors (1)

Lead Sponsor Collaborator
Chung Shan Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The change of parental uncertainty 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.
day 1 (baseline, before education), day 1 (after education), day 2-5 (discharge day)
Primary The change of parental anxiety 1 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.
day 1 (baseline, before education), day 1 (after education), day 2-5 (discharge day)
Primary The change of parental anxiety 2 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.
day 1 (baseline, before education), day 1 (after education), day 2-5 (discharge day)
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