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

Chung Shan Medical University Hospital

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.

Study Overview

• Status: Recruiting
• Conditions: Parental Anxiety; Congenital Heart Disease in Children; Catheterization; Educational Videos; Parental Uncertainty
• Intervention / Treatment: Other: routine education plus digital video disk; Other: routine education

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shu-Juan Liu; Phone Number: +886 4 24739595#220801; Email: juan012599@gmail.com

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Recruiting
    • Chung Shan Medical University Hospital.
    • Contact: Shu-Juan Liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: study group; parents receiving routine education plus digital video disk before catheterization:pre-catheterization educational videos plus routine education	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.
Other: control group; parents receiving routine education: pre-catheterization routine education	Other: routine education; Parents receiving routine education before their children receiving congenital heart disease catheterization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Collaborators and Investigators

• Sponsor: Chung Shan Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2022
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: August 3, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: CS2-22078

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No