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临床试验/NCT04966312
NCT04966312已完成不适用

Instructor School of Nursing, Chung Shan Medical University, Taichung, Taiwan

Chung Shan Medical University Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
The change of Mother's anxiety

研究概览

简要总结

To examine if educational digital video disk can reduce maternal anxiety and depression if their children undergo congenital heart disease surgery and when surgical or post-surgical complications occur. Compared to only routine education, adding digital video disk could decrease mothers' anxiety more after education, and until the day of discharge. Compared to only routine education, adding digital video disk could decrease mothers' anxiety more on the discharge day if their child had surgical or post-surgical complications.

详细描述

Aims and objectives: To examine if educational digital video disk can reduce maternal anxiety and depression if their children undergo congenital heart disease surgery and when surgical or post-surgical complications occur.

Background: Mothers experience anxiety and depression if their children undergo conditions mentioned above.

Design: A randomized control-group pretest-posttest design. The CONSORT checklist is used.

Methods: In a teaching hospital, 120 mothers whose children underwent first elective surgery for congenital heart disease were randomly divided into group 1: 60 mothers receiving routine education plus digital video disk before surgery; and group 2: 60 mothers receiving routine education. Between groups, mothers' anxiety and depression levels were compared (1) before education, (2) after education (before surgery) and (3) on the discharge day. Among mothers whose children had surgical or post-surgical complications, the effect of watching the digital video disk on anxiety and depression 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
23 Years 至 48 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Mothers, whose children underwent first elective cardiac surgery for congenital heart disease
  • Mothers should have been the primary caregivers
  • Mothers able to communicate effectively, either orally or in writing

排除标准

  • Mothers of children with genetic disorders
  • Mothers of children with non-cardiac congenital anomalies
  • Mothers of children with diseases such as cerebral palsy, epilepsy, psychiatric diseases, and * * Mothers of children with chronic lung diseases

结局指标

主要结局

The change of Mother's anxiety

时间窗: day 1 (baseline, before education), day 1 (after education), day 5-7 (discharge day)

The number scores of mother's anxiety between "routine education" and "routine plus DVD education" groups. Beck Anxiety Inventory (BAI) was used to evaluate the number scores of anxiety.

The change of Mother's depression

时间窗: day 1 (baseline, before education), day 1 (after education), day 5-7 (discharge day)

The number scores of mother's depression between "routine education" and "routine plus DVD education" groups. Beck Depression Inventory (BDI) was used to evaluate the number scores of depression.

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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