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临床试验/NCT05496803
NCT05496803Unknown不适用

Chung Shan Medical University Hospital

Chung Shan Medical University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年7月27日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
The change of parental uncertainty

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
20 Years 至 48 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

The change of parental uncertainty

时间窗: day 1 (baseline, before education), day 1 (after education), day 2-5 (discharge day)

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

时间窗: day 1 (baseline, before education), day 1 (after education), day 2-5 (discharge day)

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

时间窗: day 1 (baseline, before education), day 1 (after education), day 2-5 (discharge day)

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Chung Shan Medical University Hospital

Department of pediatrics

Chung Shan Medical University

研究点 (1)

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