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
About this trial
This is an interventional other trial for Educational Videos
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
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
NCT ID
NCT05496803
First Posted
August 3, 2022
Last Updated
August 9, 2022
Sponsor
Chung Shan Medical University Hospital
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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