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临床试验/NCT05401617
NCT05401617
终止
不适用

Impact of an Information Assistance Application in Addition to a Traditional Anesthesia Consultation on Preoperative Anxiety in Pediatrics: Prospective Randomized Trial

University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 182 人2021年5月12日

概览

阶段
不适用
干预措施
control group
疾病 / 适应症
Pediatric Surgery
发起方
University Hospital, Rouen
入组人数
182
试验地点
1
主要终点
Level of anxiety on entering the operating room
状态
终止
最后更新
18天前

概览

简要总结

The objective of the study is to evaluate the benefits on pre-operative anxiety of an information assistance application in addition to a traditional anesthesia consultation on preoperative anxiety in pediatrics

注册库
clinicaltrials.gov
开始日期
2021年5月12日
结束日期
2022年10月24日
最后更新
18天前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
University Hospital, Rouen
责任方
Sponsor

入排标准

入选标准

  • Child between 4 years old (inclusive) and 10 years old (inclusive);
  • Must benefit from programmed general anesthesia for scheduled surgery at the Rouen University Hospital, in the paediatrics ward;
  • Benefiting from a social security scheme;
  • Whose parental authority has consented to participation in the research;
  • Not having expressed their refusal to participate in the research;
  • Understanding French;
  • Ability to access the application being researched.

排除标准

  • Patient with cognitive disorders: disorders known in the history and assessed or suspected during the anesthesia consultation.
  • Poor understanding of oral French by the child;
  • Poor understanding of the oral and/or written French language by the parent/legal representative;
  • Patient presenting a contraindication to general anesthesia or to the intervention during the pre-anaesthetic visit;
  • Patient with severe psychiatric disorders

研究组 & 干预措施

control group

patient benefiting from a traditional anesthesia consultation as performed daily in the department (control group). The information will be delivered according to local customs and the MAR: oral, which can be supplemented by the delivery of the SPARADRAP booklet and the written documents usually delivered

experimental group

patient benefiting, in addition to this traditional anesthesia consultation, from additional information via the computerized tool. The operation of this tool will be explained by paramedical staff and its access will be free as soon as you leave the consultation.

干预措施: additional information via the computerized tool

结局指标

主要结局

Level of anxiety on entering the operating room

时间窗: 15 days

YALE score (also called m-YPAS SF) : 22.9 to 100

次要结局

  • Anxiety of parents(15 days)
  • Need of an analgesic supplement in SSPI (post-interventional monitoring room)(15 days)
  • Duration of stay in SSPI(15 days)
  • Parents' satisfaction with the quality of the information provided(15 days)

研究点 (1)

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