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

Primary Purpose

Educational Videos, Catheterization, Congenital Heart Disease in Children

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
routine education plus digital video disk
routine education
Sponsored by
Chung Shan Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Educational Videos

Eligibility Criteria

20 Years - 48 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chung Shan Medical University Hospital.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

study group

control group

Arm Description

parents receiving routine education plus digital video disk before catheterization:pre-catheterization educational videos plus routine education

parents receiving routine education: pre-catheterization routine education

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 3, 2022
Last Updated
August 9, 2022
Sponsor
Chung Shan Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05496803
Brief Title
Impact of Systematic Nursing Guidance on the Psychological Effects of Parents of Children With Cardiac Catheterization.
Official Title
Chung Shan Medical University Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 27, 2022 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chung Shan Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Educational Videos, Catheterization, Congenital Heart Disease in Children, Parental Uncertainty, Parental Anxiety

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Other
Arm Description
parents receiving routine education plus digital video disk before catheterization:pre-catheterization educational videos plus routine education
Arm Title
control group
Arm Type
Other
Arm Description
parents receiving routine education: pre-catheterization routine education
Intervention Type
Other
Intervention Name(s)
routine education plus digital video disk
Intervention 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.
Intervention Type
Other
Intervention Name(s)
routine education
Intervention Description
Parents receiving routine education before their children receiving congenital heart disease catheterization
Primary Outcome Measure Information:
Title
The change of parental uncertainty
Description
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.
Time Frame
day 1 (baseline, before education), day 1 (after education), day 2-5 (discharge day)
Title
The change of parental anxiety 1
Description
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.
Time Frame
day 1 (baseline, before education), day 1 (after education), day 2-5 (discharge day)
Title
The change of parental anxiety 2
Description
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.
Time Frame
day 1 (baseline, before education), day 1 (after education), day 2-5 (discharge day)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shu-Juan Liu
Phone
+886 4 24739595#220801
Email
juan012599@gmail.com
Facility Information:
Facility Name
Chung Shan Medical University Hospital.
City
Taichung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu-Juan Liu

12. IPD Sharing Statement

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

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