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临床试验/NCT05165576
NCT05165576已完成不适用

The Influence of Child-centered Communication on Children's Anxiety and Use of Anesthesia for MRI

Universidade do Porto4 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020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
90
试验地点
4
主要终点
Anesthesia count

研究概览

简要总结

The goal of this project is to study the influence of child-centered communication on children's anxiety, satisfaction and the use of anesthesia for MRI

详细描述

This study seeks to inspect the influence of a child-centered communication (CCC) on anesthesia use in magnetic resonance imaging (MRI) exams among four- to 10-year-old children. Children's levels of anxiety and satisfaction with the interaction also are assessed. Children are divided into three groups by order of arrival. Group 1 receives routine information about the MRI and simulates it with an MRI toy (EG1). Group 2 simulates the exam with the toy and receives the CCC. These two groups are compared with a third group of children who had received only the routine information about the exam and who served as a comparison group (CG).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

The investigator applied the intervention. The participant and the outcomes assessors were blind as to which group participants were assigned.

入排标准

年龄范围
4 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Ages between four and 10 years old
  • Having a medical request for the MRI in the hospital
  • The MRI performed for the first time

排除标准

  • Presenting cognitive, psychiatric or neurological conditions that prevented the understanding of communication
  • Having any intra-body devices that impeded performance of the MRI exam

结局指标

主要结局

Anesthesia count

时间窗: 30 minutes (after the Magnetic Resonance Imaging)

Number of children who perform the Magnetic Resonance Imaging exam using anesthesia

次要结局

  • Change in self-reported anxiety(20 minutes (before and after the child's preparation))
  • Change in heart rate frequency(20 minutes (before and after the child's preparation))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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