Impact of a Double-reading Animated Film (Child, Parents) in Preoperative on the Anxiety of Children Upon Arrival at the Operating Room
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- the child's anxiety score obtained from the M-Ypass scale at the time of induction in the operating room.
研究概览
简要总结
Preoperative anxiety affects 40 to 60% of children. A literature review concluded that effective preparation strategies must involve parents, must be appropriate to their age and proposed upstream of the intervention.
A double-readinganimated film aimed at informative was created for the children and their parents/legal guardians in order to solve the problem of anxiety found at the arrival of children in the operating room.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child boy or girl.
- •3 to 7 years old.
- •programmed for: removal of tonsils, vegetations, paracentesis or installation of trans-tympanic aerators, pre-heliceal fistula, otoplasty, myringoplasty
- •Scheduled intervention in the outpatient department of specialized surgeries or hospitalization of a postoperative night.
- •Accompanied by an adult, French-speaking, whose child lives at home.
- •Of which the holders of the parental authority formulated their non-opposition to the participation of their child and gave their signed agreement for the realization of videos of their child.
- •Assent of the child for children aged 6 to 7
- •Parents affiliated to social security
- •For the group under study only:
- •- Support available at home that can watch the movie on the internet
排除标准
- •Child having already had surgery.
- •Presence of associated disability (blindness, profound deafness, autistic disorders).
- •Child having anxiolytic treatment.
- •Child to be operated within less than 2 days
研究组 & 干预措施
With animated film
An animated film depicts the child and the caregivers in the form of avatars and retraces his journey from his room to the transfer area, then to the the operating room and finally to the post-intervention ward.
干预措施: Animated film (Other)
Standard route
The information about the surgery will be given by the surgeon during the consultation.
Those about anaesthesia will be delivered by anaesthesiologist during the anaesthetic consultation.
结局指标
主要结局
the child's anxiety score obtained from the M-Ypass scale at the time of induction in the operating room.
时间窗: The duration of this visit will be about 3 hours, between the reception at the outpatient and the time of induction in intervention room, end of the study
Evaluation of this outcome measure will be made between 0 and 6 months after the inclusion. m-Ypass scale (Modified Yale Preoperative Anxiety Scale), a hetero-evaluation scale, is designed to assess preoperative anxiety in children aged 3 to 7 years. It has 18 items divided into 4 groups (activity, vocalizations, emotional expression, apparent state of awakening). Each group having a different number of items (4 or 6), quotients are calculated and then added together to obtain a total score ranging from 0 to 100 (Appendix 2: Anxiety score of Yale Mulhouse and Colmar). The children will be filmed at 3 times of their care on the day of the intervention. The reading of these videos will be done afterwards by two nurses from the Department of Pain Support Unit (CHU Bordeaux, neuroscience center), independent of the services concerned by the study, trained on a scale by the investigator, in order to establish anxiety scores.
次要结局
- the child's anxiety score obtained from the EVA-A for the parent/legal guardian.(at the time of induction in the operating room)
- the child's anxiety score obtained from the M-Ypass scale(at their arrival at the transfer area of the operating room)
- the child's anxiety score obtained from the M-Ypass scale at their arrival in ambulatory service(The duration of this visit will be about 3 hours, between the reception at the outpatient and the time of induction in intervention room, end of the study)