Impact of an Information Assistance Application in Addition to a Traditional Anesthesia Consultation on Preoperative Anxiety in Pediatrics: Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Level of anxiety on entering the operating room
研究概览
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
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
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 (Other)
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)