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临床试验/NCT04605536
NCT04605536已完成不适用

Effect of Animation Video on the Success Rate of Children Swallowing Capsule Endoscopy: a Randomized Controlled Trial

Children's Hospital of Fudan University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年10月22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
200
试验地点
1
主要终点
success rate of swallowing capsule endoscopy

研究概览

简要总结

There are a variety of strategies that can be used for education to improve patients' awareness of the electronic capsule endoscopy process at present. The animated images in the animation videos are interesting as the explanations are simple and easy to understand. It is one of the best choices for children's education. A number of studies have shown that animated videos can increase the awareness rate of children's related knowledge, reduce anxiety, improve children's compliance with examinations and operations, and achieve good clinical results. Effective information transmission to children and their family members can increase the children's cognition and may affect the children's compliance with swallowing capsules and the success rate of autonomous swallowing, thereby reducing the time for swallowing capsule endoscopes and increasing capsule endoscopes Complete small bowel examination completion rate. This study aimed to evaluate the impact of animated video education on the success rate of children swallowing capsule endoscopy and analyze the related factors that affect the time for children to swallow capsules autonomously.

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
Single (Outcomes Assessor)

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Have indications for capsule endoscopy;
  • Agree to undergo capsule endoscopy;
  • Have normal intelligence and can communicate with the operator normally.

排除标准

  • Contraindications for capsule endoscopy;
  • Previous experience of capsule endoscopy;
  • Allergic to polymer materials;
  • Persons with mental retardation;
  • Those who cannot communicate normally due to diseases or emotions;
  • A HAMA scale of 21 or above, which indicates severe anxiety, before the examination

结局指标

主要结局

success rate of swallowing capsule endoscopy

时间窗: 48 hours

The success rate of children swallowing capsule endoscopy spontaneously

次要结局

  • Heart rate(48 hours)
  • Adverse effects(24 hours)
  • HAMA anxiety score(24 hours)
  • Swallowing time(24 hours)

研究者

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

Ying HUANG

Director

Children's Hospital of Fudan University

研究点 (1)

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