Audiovisual Interactive Games to Improve Pediatric Patient Cooperation With Induction of Anesthesia and Alleviate Perioperative Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 2
- 主要终点
- Patient Anxiety Assessed by Modified Yale Perioperative Anxiety Score (mYPAS)
研究概览
简要总结
Pediatric anxiety upon induction of anesthesia is widely prevalent and can lead to negative patient psychological impact and hindrance to induction of anesthesia. Historically, premedication has been used as one means to improve pediatric preoperative anxiety and cooperation with induction. However, giving medication to children prior to surgery has drawbacks. Thus, other means have been proposed that may have similar benefits but fewer or different drawbacks. Recently, audiovisual distraction in the form of interactive games has been proposed. Such games have been in use at children's hospitals around the United States for more than five years. This study is a randomized trial that will explore using interactive games to improve pediatric perioperative anxiety in elective surgery compared with standard-of-care not including games. Perioperative anxiety with be evaluated using an observational scale.
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 (Participant, Investigator)
盲法说明
In the first phase (baseline measurement) neither participant nor investigator will be aware of the subjects group assignment. After this phase, due to the nature of the intervention, the experimental group will be aware they are in the intervention group when they see the gaming system.
入排标准
- 年龄范围
- 4 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •4 to 14 years of age;
- •Undergoing non-emergent surgery at Yale New Haven Children's Hospital requiring general anesthesia;
- •Chooses inhalational induction as induction method;
- •Surgery qualified under one or more of the following fields: otolaryngology, ophthalmology, orthopedics, dentistry, gastrointestinal, general surgery
排除标准
- •Altered mental status;
- •Significant audiovisual deficits (per parent report and at discretion of study team);
- •Received pharmacologic premedication
结局指标
主要结局
Patient Anxiety Assessed by Modified Yale Perioperative Anxiety Score (mYPAS)
时间窗: Baseline at OR entry (approximately 1 hour after baseline) and At Induction of Anesthesia (approximately 65 minutes after baseline),
The mYPAS is the gold standard for measuring pediatric perioperative anxiety. It is an observational-based 22-item instrument divided into five categories: activity, emotional expressivity, state of arousal, vocalization, and use of parents. The score ranges from 23 to 100, higher scores suggest higher levels of anxiety. It was developed at Yale University. This will be used for child participants only. Results presented here are mean change from baseline in anxiety during induction and upon Operating Room (OR) entry.
次要结局
- Mean Change in Caretaker Anxiety Assessed by Short State Anxiety Inventory Score(Baseline, After Induction of Anesthesia (approximately 1 hour after baseline))
- Healthcare Professional Opinions on BERT Assessed With Health Professional Survey(During first 10 study days)
- Patient Induction Compliance Assessed by Induction Compliance Checklist(At Induction of Anesthesia)