跳至主要内容
临床试验/NCT06303843
NCT06303843已完成不适用

The Effect of Electric Ride-On Cars Use During Transport to the Operating Theatre on Preoperative Anxiety in Children Undergoing Elective Ambulatory Surgery: A Randomised Controlled Trial

Uşak University2 个研究点 分布在 2 个国家目标入组 118 人开始时间: 2023年5月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
118
试验地点
2
主要终点
Perioperative anxiety

研究概览

简要总结

The aim of our study was to evaluate the effect of the use of a electric ride-on car during transport to the operating theatre on preoperative anxiety in children undergoing elective ambulatory surgery. As a distraction method, children in the experimental group will be introduced to the operating theatre with a electric ride-on car. Yale Modified Preoperative Anxiety Scale Child Form will be used to evaluate anxiety. The sample size was determined as 118 as a result of power analysis. 59 children will be included in the experimental group and 59 children in the control group.

Translated with DeepL.com (free version)

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
2 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Being between 2-10 years old,
  • Less than 35 kg (according to the manufacturer's instructions for ride-on battery cars),
  • To undergo elective surgery,
  • Volunteering to participate in the study.

排除标准

  • having cognitive or physical disabilities that may prevent riding a electric ride-on car
  • premedication before surgery

研究组 & 干预措施

Intervention group

Experimental

Transfer to the operating theatre with an electric ride-on car

干预措施: Transfer with an electric ride-on car (Other)

Controlled group

No Intervention

Transfer to the operating theatre with a paediatric trolley

结局指标

主要结局

Perioperative anxiety

时间窗: 30 minutes

Yale Modified Preoperative Anxiety Scale Child Form

次要结局

未报告次要终点

研究者

发起方
Uşak University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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