Does Virtual Parental Presence Reduce Preoperative Anxiety in Children: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Anxiety in children
研究概览
简要总结
Children undergoing anesthesia are often very frightened by the experience. This can lead to bed wetting, nightmares and stranger anxiety that can last for weeks. Moreover, this can influence their future experiences with anesthesia and surgery. The investigators believe the presence of a parent via video might work better as parental fear is not transferred to the child. The investigators also believe that parents who are coached on how to assist their child during anesthesia will have a better impact. As such the investigators are carrying out this study to assess whether parents who are coached and are present in either video or physical form will be more effective in reducing anxiety at induction of anesthesia.
详细描述
The investigators' goal in this study is to investigate the effects of virtual parental presence and coaching of parents on anxiety in children at induction of anesthesia. The primary hypothesis is virtual parental presence during induction of anesthesia is superior to physical parental presence during induction of anesthesia in reducing anxiety in children at induction of anesthesia. The secondary hypothesis is that the coaching of parents modulates the effect of physical or video parental presence at induction anesthesia on children's anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children from ages 18 months to 12 years old
- •American Society of Anesthesiologists physical status I, II or III
- •No previous exposure to anesthesia or surgery
- •Same Day surgery
- •English speaking parents and child
排除标准
- •Children with developmental delay
- •Children with psychological / emotional disorders
- •Children with language barrier
- •Previous anesthetic or surgical experience
- •Children whose eyes will be closed following surgery
- •Children on sedative or psychoactive medication
- •History of allergy to medications in our study
- •Children with expected difficult intubation
- •Children presenting for emergency surgery
- •Family history or personal history of malignant hyperthermia / risk of malignant hyperthermia
- •Consent not obtained or withdrawal of consent
- •Children who are violent during induction of anesthesia
- •Cancellation of surgery
结局指标
主要结局
Anxiety in children
时间窗: Day of surgery, immediately following consent
measured using the modified Yale Preoperative Anxiety Scale (mYPAS)
Change in child anxiety
时间窗: Day of surgery, immediately preceding surgery
measured using the modified Yale Preoperative Anxiety Scale (mYPAS)
次要结局
- Parental anxiety(Day of surgery, immediately following consent)
- Anesthesiologist satisfaction with task load(Day of surgery, immediately following surgery)
- Anesthetic requirements(Day of surgery, from time of randomisation up to 4 hours afterwards)
- Induction compliance(Day of surgery, immediately preceding surgery)
- Change in parental anxiety(Day of surgery, immediately preceding surgery)
- Parental satisfaction(Day of surgery, five minutes after surgery has commenced)
- Post-hospitalization negative behaviours(Two to three days after surgery)
- Child temperament(Day of surgery, immediately following consent)
- Anesthesiologist satisfaction with technology usability(Day of surgery, immediately following surgery)
- Induction nurse satisfaction with task load(Day of surgery, immediately following surgery)
- Induction nurse satisfaction with technology usability(Day of surgery, immediately following surgery)
研究者
Clyde Matava
Staff Anesthesiologist
The Hospital for Sick Children