The Effects of Operating Room Virtual Tour on Preoperative Anxiety, Emergence Delirium and Postoperative Behavioral Changes of Pediatric Patients: Prospective, Randomized, and Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Emergence delirium
研究概览
简要总结
Preoperative anxiety is associated with adverse consequences such as emergence delirium, and postoperative behavioral changes. According to previous studies, providing information of anesthetic procedures helps to lessen preoperative anxiety. However, verbal explanation alone provides the limited effect, and the tour program of the operating room prior to surgery may not be possible for a number of hospitals due to organizational and financial reasons. Therefore, the virtual reality (VR) tour of the operating room may be an innovative and novel method to give children information about the preoperative process and to alleviate the preoperative anxiety. In this study, we intend to evaluate the effects of the operating room virtual tour on preoperative anxiety as well as emergence delirium and postoperative behavioral changes, in pediatric patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective surgery
- •American Society of Anesthesiologist (ASA) physical class I, II
- •Informed consent; Children aged between 4 and 6 years old are allowed to have verbal consent and their parents provide informed written consent. Children over the age of 7 are required to obtain a written consent with parental permission.
排除标准
- •ASA class ≥ III
- •Major surgery needing postoperative intensive care unit (ICU) admission.
- •Chronic disease or history of preterm birth
- •Developmental delay
- •Hearing or vision impairment
- •Affective disorder
- •History of epilepsy or seizure
- •Previous experience of general anesthesia
结局指标
主要结局
Emergence delirium
时间窗: At 5 minutes after arrival in post-anesthesia care unit (PACU)
Pediatric Anesthesia Emergence Delirium (PAED) scale
次要结局
- Preoperative anxiety(2 times; before the intervention (baseline) and, at waiting area, before the operating room entrance (preoperative))
- Postoperative behavioral change(2 times; on the 1st and 14th day (2 weeks) after the surgery, we will call and talk with the parents)
研究者
Sung-Hee Han
Professor
Seoul National University Bundang Hospital