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临床试验/NCT04199637
NCT04199637已完成不适用

The Anxiety and Resisting Behavior Evaluation of Therapeutic Video Games for Pre-school Children With Acute Lymphoblastic Leukemia: Randomized Controlled Trial

National Yang Ming Chiao Tung University2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年12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
15
试验地点
2
主要终点
The change of face pain rating scale

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness of therapeutic video game.

详细描述

Children cancer was the third-ranked causes of children's death. During the long treatment courses, children are always forced to accept lots of drug therapy and invasive procedures without understanding the medical purpose. Due to the immature cognition, always lead to anxiety in childhood cancer patients. Our team developed a mobile technology platform based therapeutic video game (TVG) for preschoolers with acute lymphoblastic leukemia (ALL) in early 2018. Then three clinical experts were invited to validate TVG and had high appropriateness consensus. Then the pilot study was conducted in one medical center in Taipei and 10 preschoolers with ALL had been randomly signed in two groups-5 to intervention group (6 weeks game intervention) and 5 to control group (regular care). The preliminary results showed that crying scale and resisting behavior were no significance between two groups in the initial period (p=.663), but the intervention group showed lower crying grades and less resisting behavior than the control group in the final period (p=.028). The limitation of this pilot research was small sample size and short intervention time. Therefore, the purpose of this study is to increase the sample size and intervention time to evaluate the effectiveness of our TVG.

Methods: A total of 68 fresh ALL preschool children will be randomized divided equally into intervention group and control group. Only intervention group

研究设计

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

入排标准

年龄范围
3 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • non TPOG therapy
  • without Port-A
  • under PBST treatment
  • ALL recurrent
  • mental retardation

结局指标

主要结局

The change of face pain rating scale

时间窗: The continuous 8 weeks after recruiting

Face pain rating scale(0 means for no hurt; 10 means for hurts worst) is measured by participants' family after receiving invasive therapies for continuous 8 weeks after recruiting.

次要结局

未报告次要终点

研究者

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

I-Ching Hou

Assistant Professor

National Yang Ming Chiao Tung University

研究点 (2)

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