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临床试验/NCT04206956
NCT04206956Unknown不适用

Anxiety and Chronic Postsurgical Pain Following Ambulatory Surgery in Children

Centre Hospitalier de Saint-Brieuc1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2019年10月14日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
135
试验地点
1
主要终点
Chronic postsurgical pain in children

研究概览

简要总结

Prospective, monocentric, observationnal study. The primary objective of this study is to identify if presurgical child or/and parental anxiety is predictive of chronic postsurgical pain in abdominal or urologic ambulatory surgery.

详细描述

The post surgical pain guidelines recommend to identify predictive factors, especially for vulnerable subjects.

For children, there is few data about predictive factors of postoperative pain after ambulatory surgery.

The objective of this study is to collect preoperative data (preoperative children's anxiety and parental anxiety) and postoperative data (postoperative pain measure: the day of surgery and 3 months after surgery) for children undergoing abdominal ou urologic ambulatory surgery, and to determine if there is a relationship between these data (Odds Ratio)

研究设计

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

入排标准

年龄范围
3 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • child from 3 to 18 years old
  • undergoing scheduled urology or abdominal ambulatory surgery
  • child and parents speaking French
  • affiliation to national health insurance

排除标准

  • emergency surgery
  • lack of parents consent
  • no parental support on surgery day

结局指标

主要结局

Chronic postsurgical pain in children

时间窗: 3 months after surgery

For all children, score PPMP (Postoperative Pain Measure for Parents) From 0 (better) to 10 (worse)

Children's preoperative anxiety

时间窗: Preoperative : day of surgery

- For children younger than 12 : mYPAS (the Modified Yale Preoperative Anxiety Scale). If the score is less than 24 : quiet child. If the score is greater than 24 : anxious child - For children older than 12 : anxiety visual analog scale (VAS) From 0 (better) to 10 (worse)

Parents' preoperative anxiety

时间窗: Preoperative: day of surgery

anxiety visual analog scale (VAS) From 0 (better) to 10 (worse). More than 3/10 means "anxious"

children's pain

时间窗: postoperative: day of surgery

* for children younger than 6: Evendol scale. From 0 (better) to 15 (worse) * for children older than 6: anxiety visual analog scale (VAS) From 0 (better) to 10 (worse).

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier de Saint-Brieuc
申办方类型
Other
责任方
Sponsor

研究点 (1)

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