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临床试验/NCT03205397
NCT03205397已完成不适用

Impact of a Child-Parent Preoperative Accompanying Procedure on the Anxiety of Children Aged 5 to 12 With Scheduled Surgery

University Hospital, Limoges2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年8月17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
50
试验地点
2
主要终点
Level of anxiety

研究概览

简要总结

In France, during surgery, only 4% of parents are present at induction, most often for children with disabilities with iterative interventions. Some studies have shown that the presence of parents during induction decreases the anxiety of children, while others do not. Their conclusions all advocate preparing parents for this presence in the operating room in an accompanying course.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 5 to 12 year olds requiring scheduled surgery
  • scheduled outpatient or weekly hospitalization.
  • Anesthesia envisaged by inhalation induction
  • Agreement of parents (and child according to age).
  • Even parent (s) present at pre-anesthesia and on the day of surgery

排除标准

  • Child with previous surgery
  • Parent (s) of a child who has already had surgery
  • Parent (s) or child unable to follow the whole procedure (autism, blindness ...)

研究组 & 干预措施

Accompanying and information procedure

Experimental

Preparation for anesthesia (explanations, film, booklet), the presence of a relative in the operating room and the awakening of the child.

干预措施: Experimental Group (Other)

Usual care

Other

Consultation of anesthesia and the care of the child without parental presence

干预措施: usual care (Other)

结局指标

主要结局

Level of anxiety

时间窗: 10 minutes

Level of anxiety measured at the time of anesthetic induction by the MYPAS hetero-evaluation scale

次要结局

未报告次要终点

研究者

发起方
University Hospital, Limoges
申办方类型
Other
责任方
Sponsor

研究点 (2)

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