跳至主要内容
临床试验/NCT04627909
NCT04627909已完成不适用

Emotional Support of a Social Robot at the Pediatric Emergency Department: a Randomized Clinical Trial

University of L'Aquila1 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2019年7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
109
试验地点
1
主要终点
Salivary cortisol level

研究概览

简要总结

The investigators are evaluating if the use of humanoid robots is an optimal distraction strategy in order to produce positive emotional states and facilitate the diagnosis and to reduce treatment time in pediatric age in emergency situations.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • children between the ages of 3 and 10 with white, green and yellow triage code

排除标准

  • Red triage code
  • inadequate knowledge of the Italian language,
  • yellow triage code in case of: headache for recent trauma with visual impairment; headache with neck rigidity or vomiting; indifference to the environment; dyspnea and increased respiratory work; intoxication by inhalation of toxic substances; significant trauma to the head with altered state of consciousness.

结局指标

主要结局

Salivary cortisol level

时间窗: The surveys have been made when children arrived, after their assigned 15-minutes interaction, and twenty minutes before medical physical examination.

The children's salivary cortisol production was measured over time to obtain a clear picture of the trend of the children's stress level before the emergency medical procedures.

次要结局

  • Psychological tests(The surveys have been made after a 15-minute interaction with the robot or mother or medical staff.)

研究者

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

Clara Balsano

Ordinary professor

University of L'Aquila

研究点 (1)

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