Analysis of the Link Between Flow State and Preoperative Anxiety in Children Undergoing Playful Distraction - Studying the Benefits of Digital Distractions in an Ambulatory Care Service
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- correlation between the flow state and preoperative anxiety
研究概览
简要总结
This study focuses on preoperative anxiety in children and non-drug methods to reduce anxiety.
During surgery under general anesthesia, children may be anxious because of separation from their parents, fear of anesthesia, or loss of control.
In order to reduce the anxiety of the child, anesthesiologists sometimes use an anxiolytic medicine. This premedication can reduce the anxiety of children. However, side effects are often observed as rebound anxiety after the operation or a delay to discharge from hospital.
In recent years, alternative methods to premedication have been studied to reduce the anxiety of children. For example, video games and cartoons are distraction methods. Studies have shown that using a video game or cartoon during the waiting phases (in the room, when traveling, in the permutation room) reduces the anxiety of children and with the same efficiency as anxiolytic.
In this study, the investigators will evaluate the effectiveness of a tablet game and a cartoon to reduce the anxiety of children.
详细描述
This study takes an interest on the problem of the well-being of children during an outpatient surgery.
Children are often anxious before a surgery under general anesthetic because of unfamiliar environments, separation from parents, loss of control or uncertainty about anesthesia. 50% to 70% of children develop anxiety after surgery. Anxiety before surgery are associated with behavioral changes in postoperative like increase in anxiety, sleep or eating disturbances and with postoperative pain.
To reduce this preoperative anxiety, the use of anxiolytics (hypnovel, hydroxizyne) is the most commonly used method. But this premedication remains controversial (paradoxical effects with rebound of anxiety, loss of explicit memorization).
The aim of this study is to examine two non-pharmacological and non-invasive methods (technological distraction through video games and animated cartoons) that seem to be effective in reducing preoperative anxiety and its postoperative repercussions. Much studies show the benefits of preoperative distraction method to reduce children's anxiety, such as cartoons, video games, puzzles.
It is now necessary to understand the processes underlying the relationship between the preoperative anxiety and distraction method.
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
- None
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 3 to 10 years
- •Benefiting from an ambulatory surgery under general anesthesia
- •Whose parents or the legal representative of the parental authority do not object to his participation
- •Written consent of one of the parents or the legal representative of the parental authority to the video recording of the child.
排除标准
- •Children participating in another study
- •No understanding of the French language by the parents and/or the child
- •Major developmental delay, psychiatric pathology or visual impairment that does not allow the children to play on a tablet.
研究组 & 干预措施
Video game
Children receive a tablet with a video game at their arrival on the unit until the introduction of the anesthesia mask.
The video game used is "Le Héros C'est Toi", a game specially developed for the unit. The game recreates the hospital environment and includes mini-games geared to children
干预措施: Video game (Behavioral)
Animated cartoon
Children receive a tablet with an animated cartoon at their arrival on the unit until the introduction of the anesthesia mask.
The cartoon used is "L'âge de glace", an animated cartoon geared to children.
干预措施: Animated cartoon (Behavioral)
结局指标
主要结局
correlation between the flow state and preoperative anxiety
时间窗: On the day of surgery
This will involve assessing the correlation between the flow state and preoperative anxiety. The tool used is the mYPAS. It is an observation based-method. Observation grid is composed of five dimensions : activity, vocalizations, emotional expressivity, state of apparent arousal, use of parents. The observer chooses a score for the five dimensions based on the criteria provided in the grid. The tool used is the Flow Observation Grid. It is an observation based-method. Observation gri dis composed of three dimensions : concentration, joy, frustration. The observer chooses a score for the three dimensions based on the criteria provided in the grid.
次要结局
未报告次要终点