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临床试验/NCT01529021
NCT01529021已完成不适用

Reducing Children's Distress Towards Flu Vaccinations

University of Calgary1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2011年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
57
试验地点
1
主要终点
Faces Pain Scale-Revised

研究概览

简要总结

Millions of children in North America receive an annual flu vaccination, many of whom are at risk of experiencing severe distress. Children frequently use technologically advanced devices such as computers and cell phones. Based on this familiarity, the investigators introduced another sophisticated device - a humanoid robot to- interact with children during their vaccination. The investigators hypothesized that these children would experience less distress than children who did not have this interaction.

详细描述

57 children (30 male; age, mean + SD: 6.87 + 1.34 years) were randomly assigned to a vaccination session with a nurse who used standard administration procedures, or with a robot who was programmed to use cognitive-behavioral strategies with them while a nurse administered the vaccination. Measures of distress were completed by children, parents, nurses, and researchers.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
5 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ages 5-9 years,
  • boys and girls

排除标准

  • children with pervasive developmental disability

结局指标

主要结局

Faces Pain Scale-Revised

时间窗: 5 mins before and immediate after vaccination

The Faces Pain Scale-Revised was administered to children and their parents while in the waiting room and after consent was signed. Once this questionnaire and consent were completed, the parent and child entered the vaccination room for the vaccination. As soon as the vaccination was completed, the Faces Pain Scale-Revised was re-administered.

次要结局

  • Behavioral Approach-Avoidance Distress Scale(one week after vaccination was administered)

研究者

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

Tanya Beran

Associate Professor

University of Calgary

研究点 (1)

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