Impact Assessment on Anxiety of Using a KOALOU® Digital Application for Children Undergoing Scheduled Ambulatory Surgery Compared to Those Who do Not Use the Application .
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Preoperative anxiety in the operating room before the induction
研究概览
简要总结
The prospect of pediatric surgery is a source of preoperative anxiety for children and their parents. It affects 50% of children waiting for surgery and the causes vary according to age. It has been shown that pre-operative anxiety in children often leads to behavioral changes. Pre-operative anxiety is often managed by pharmacological premedication. However, there are many alternative techniques to reduce children's anxiety before surgery.
The use of an application dedicated to pediatric anesthesia used from the moment of the anesthesia consultation would allow to reduce this anxiety by allowing a varied course of information involving the child in his preparation before the surgery.
First, it allows an evaluation of the pre-operative anxiety level of children via validated scales. Secondly, it provides information to the children using methods adapted to their age and level of understanding.
Thus, if this method were validated, other hospitals could use this application to develop a tool that would benefit the many children who undergo surgery each year.
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
- None
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from 3 to 12 years old.
- •Outpatient hospitalization for a scheduled surgery or procedure under general anesthesia.
- •Clinically stable condition.
- •Information note sent to parents and collection of their consent to their child's participation in the study.
- •Parental affiliation to a social security system.
排除标准
- •Urgent intervention situation.
- •Patient included in another study.
- •No compatible hardware for the application or no internet connection (smartphone, tablet, computer).
- •Patient not affiliated to social security.
- •Mental retardation or psychoactive disorders.
- •Intravenous induction.
- •Need for premedication.
- •Patient who had general anesthesia less than one year ago and/or after the age of
- •Patient who had surgery less than one year ago and/or after the age of
- •Child's refusal.
研究组 & 干预措施
Access to the KOALOU(®) digital application
干预措施: KOALOU(®) digital application (Behavioral)
No access
结局指标
主要结局
Preoperative anxiety in the operating room before the induction
时间窗: in the operating room before the induction
Compare the anxiety of children in the operating room before induction according to the use or not of the KOALOU® application. The primary endpoint is defined by the mYPAS-SF score calculated in the operating room before induction. The mYPAS-SF is the Yale Preoperative Anxiety Scale in his short form. It is going from 4 to 18. 4 is the minimal level of anxiety and 18 is the maximal level of anxiety.
次要结局
- Anxiety of the parents(In our hospital the chid is going alone in the operating room. The anxiety of the parents is measured in the hospitalization room after the separation with the child when the child is going in the operative room)
- Postoperative maladaptative behavioral(during the day-7 phone call)
- Acceptance of the mask(At the time of the induction)
- Agitation of the child(in the postoperative monitoring room after the operation when the child is waking up. It is measured just after the entry and just before the exit of the postoperative monitoring room)
- Preoperative anxiety in the surgery department before the surgery(in the surgery department before the surgery)