Impact of Systematic Nursing Guidance on the Psychological Effects of Parents of Children With Cardiac Catheterization.

Congenital Heart Disease in Children Clinical Trial

Official title:

Chung Shan Medical University Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05496803
• Other study ID #: CS2-22078
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Catheterization
• Congenital Heart Disease in Children
• Heart Defects, Congenital
• Heart Diseases
• Parental Anxiety

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)