Effects of Virtual Reality on Perioperative Pediatric Anxiety
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Perioperative Anxiety level
研究概览
简要总结
This study evaluates the effect of virtual reality on anxiety levels in a pediatric surgical population. Half of participants will receive standard perioperative treatment, while the other half will receive additionally a virtual reality local program.
详细描述
It is well known that there is a high incidence of significant anxiety in pediatric population perioperatively, with adverse side effects in terms of emergence delirium and maladaptive postoperative behaviors. Many different strategies have been designed in order to minimize these negative consequences.
Virtual reality is a new and simple technology that can be used at young ages. The aim of this study is to measure anxiety levels at different times in children scheduled for ambulatory surgery compared to patients with standard care without virtual reality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child between 4 and 12 years old
- •Elective ambulatory surgery
- •Parents posses a smart phone
- •Child and parents understand Spanish or Catalan
- •Patient information has been explained
- •Informed Consent is signed
- •Surgery scheduled in the morning
排除标准
- •Child has hearing impairment
- •Child has visual impairment
- •Child has previous experience of anesthesia
- •American Society os Anesthesiologists (ASA) score of III or greater
- •Children with history of seizures
- •Children under psychiatric treatment
研究组 & 干预措施
Virtual reality program group
Virtual reality program based on a virtual reality guided tour registered in the investigator's pediatric OR setting before surgery.
干预措施: Virtual Reality glasses (Device)
control group
standard perioperative care without virtual reality program
干预措施: standard perioperative care without virtual reality program (Procedure)
结局指标
主要结局
Perioperative Anxiety level
时间窗: baseline to 1 day
In children: measured using the modified Yale Perioperative Anxiety Scale, blinded reported by a trained nurse before the patient is transferred to the operating room. Rage from 23.5 up to 100, deemed high anxiety level if test rated over 30
次要结局
- Salivary Cortisol level(baseline to 1 day)
研究者
Teresa Franco
Principal investigator, Medical Doctor
Germans Trias i Pujol Hospital