The Influence of a Pre-Operative Preparatory Virtual Reality Program on the Self-Assessed Anxiety of Children Undergoing Elective Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Perioperative anxiety level of children immediately before surgery (VAS-A)
研究概览
简要总结
Does the introduction of a preparatory virtual reality (VR) program that is used in the home environment, have an effect on the anxiety level of children immediately before surgery, prior to administration of preoperative sedatives?
详细描述
Up to 60% of children who require elective surgery report significant anxiety in the preoperative setting. Severe perioperative anxiety of a child poses a major challenge for the surgeon, since it is often accompanied by adverse behavioral and emotional reactions and associated with a complicated operative and postoperative course.
The investigators have made the personal experience that informing the children ahead of time about what to expect in the hospital, decreases child anxiety and increases parent satisfaction.
There is considerable debate on the best way how to inform children about what to expect during their hospital stay. The investigators had a virtual reality application developed that introduces the children to several aspects of the hospital environment. Therefore, these children now ahead of time what they will experience during their hospital stay.
The aim is to evaluate the effect of this preparatory virtual reality application on the anxiety level of children immediately before surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The child is between the age of 7 and 13 years
- •The child is undergoing an elective surgical procedure under general anesthesia
- •The child understands Swiss German
- •The parent(s) understand(s) German
- •The parent(s) possess a smart phone
- •Internet access is given
- •The patient information has been explained
- •Informed Consent is signed
排除标准
- •The child has a hearing impairment
- •The child has neurologic disorder
- •The child requires postoperative intensive care
- •The child has previous experience of anesthesia
- •American Society of Anesthesiologists (ASA) score of III or greater
结局指标
主要结局
Perioperative anxiety level of children immediately before surgery (VAS-A)
时间窗: 2 - 90 days after recruiting
Perioperative anxiety level of children as measured by the Visual Analog Scale for Anxiety (VAS-A), immediately before surgery, prior to administration of preoperative sedatives (T2). The VAS-A scale consists of a 10 cm long, horizontal line, supplemented by two labels: "no anxiety or fear" at the left end, "worst possible anxiety or fear" at the right end of the scale.
次要结局
- Perioperative anxiety level of Children VAS-A(2 - 90 days after recruiting)
- Perioperative anxiety level of Children VFAS(2 - 90 days after recruiting)
- Perioperative anxiety level of accompanying parent(14 - 110 days after recruiting)
- Non-disease specific secondary Outcomes(14 - 110 days after recruiting)
研究者
Thoralf Liebs
PD Dr. med. Thoralf R. Liebs, consultant orthopaedic surgeon, pediatric orthopaedics, special orthopedic surgery
Insel Gruppe AG, University Hospital Bern