Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure by m-YPAS.
研究概览
简要总结
Background: Preoperative Anxiety is a negative factor in anesthetic and surgical experience. Among the strategies for reducing children's anxiety, non-pharmacological strategies are as important as the pharmacological ones, but their its validity is still controversial.
Objectives: The aim of this study is to verify if the information provided to relatives as well as and smartphone application provided to children interferes in prevalence and level of child preoperative anxiety.
Methods: Eighty four children, 4-8 years old, ASA I, II and III, undergoing elective surgical procedures and their relatives are randomly allocated into four groups: control group (CG) where the relative received conventional information about anesthesia; info group (IG), relative received an information leaflet about anesthesia; device group (DG), relative received only conventional verbal information and the child received smartphone application immediately before entering the operating room; device and info group (DIG) relative received a leaflet containing information and the child received smartphone application. Children's anxiety will be assessed using the modified Yale Preoperative Anxiety Scale (m-YPAS) on three occasions: at the ward (W), surgical theater in the waiting room (WR) and at the operating room (OR). Statistics analysis will employ by Kruskall-Wallis and Mann-Whitney tests for prevalence and level of anxiety in the groups.
详细描述
Introduction
Intense preoperative anxiety in children has been associated with difficulty in anesthetic induction. In addition, anxiety of relatives is a factor of great importance and influence on the preoperative anxiety levels of children and effectively contributes to the development of behavioral changes in postoperative period.
Distress before surgery has been associated with short- and long-term consequences, including risks of emergence delirium and maladaptive postoperative behaviors. Strategies to decrease children's anxiety can provide suitable induction and minimizes these risks.
It is estimated that 40% to 75% of children undergoing surgery experience significant fear and anxiety during the preoperative period3-5 Several authors suggest that children under 4 years of age are at greater risk for developing anxiety preoperatively.
Among the strategies for reducing the pediatric population anxiety, the non-pharmacological approaches through alternative therapies that act on the psychological aspects are as important as the pharmacological ones 9.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA physical status I, II and III a
- •age between 4 and 8 years
- •undergoing minor-medium elective surgical procedures
- •indication of general anesthesia
- •not receive premedication
- •parents are not illiterate.
排除标准
- •psychomotor deficits
- •use of psychoactive drugs
- •hearing and visual impairment
- •previous surgery
- •for relatives, illness or mental disorder clinically recognized and decline to participate.
结局指标
主要结局
Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure by m-YPAS.
时间窗: 24 hours before surgery
The level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (\< 30).
次要结局
未报告次要终点
研究者
Débora de Oliveira Cumino
MSC
Faculdade de Ciências Médicas da Santa Casa de São Paulo