Study of the Contribution of Virtual Reality Distraction in Peripheral Intravenous Catheter Insertion to Children From 6 to 11 Years in a Pediatric Day Hospital
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- change from baseline child's pain at 30 minutes after the care
研究概览
简要总结
Main objective :
Evaluate the effect of using a virtual reality mask during the peripheral intravenous catheter insertion in a pediatric day hospital on the pain and anxiety in children from 6 to 11 years old.
Hypothesis :
Using virtual reality mask during the peripheral intravenous catheter insertion would reduce the 6 to 11 child's pain, the children and parents' anxiety, would improve satisfaction of children, parents and nurse about the care and would reduce time and cost of the procedure.
详细描述
Peripheral intravenous catheter insertion is a difficult, painful and anxiety-provoking procedure for hospitalized children, with the possible memorization of pain being even more present for children with chronic pathologies.
Memorization of painful events plays an essential role in anticipating the next experience and can lead to long-term consequences. The child, whose cognitive faculties are gradually developing and whose emotions are very invasive, is particularly concerned by this repercussion.
Different techniques can be used to prevent pain during care (apart from "human" techniques such as comfort, distraction by voice, information on gesture... which are part of good practice).
The national drug safety agency recommends the use of the local anesthetic cream and/or an equimolar mixture of oxygen and nitrous oxide causing surface anesthesia and relaxation and amnesia of the gesture.
Immersion in virtual reality allows to saturate the child's sensorially (3D vision, hearing and kinesthetic proprioception) thus reducing nociceptive perceptions and anxiety. His attention is focused by the virtual animation proposed during this experience. There are many devices (glasses, masks...) as well as various programs more or less specific to care situations, some of them allow to interact with games.
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
- None
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children from 6 to 11 years old requiring an intravenous catheter insertion in a pediatric day hospital at the Clermont Ferrand University Hospital.
- •Subjects and their parents who were informed about the study and gave informed consent
- •Subjects who have had local anesthetic cream for 1-5 hours at the puncture site
- •On the first attempt to apply intravenous catheter on the day of inclusion
- •Subjects and their parents able to use the self-report scales proposed in the study.
排除标准
- •Children from 6 to 11 :
- •Having a modification of pain's integration (spina bifida for example)
- •Having received an analgesic before the care
- •Requiring contact isolation
- •With a history of seizures or motion sickness
- •Born very prematurely (< 28 SA)
- •Presenting a contraindication to the use of the local anesthetic cream
- •Presenting a contraindication to the use of the anesthetic and anxiolytic gas.
- •Presenting a contraindication to the use of the virtual reality mask: heart disease, epilepsy, psychiatric illness (major anxiety, post traumatic stress syndrome)
结局指标
主要结局
change from baseline child's pain at 30 minutes after the care
时间窗: - Before the care - Immediately after the care - 15 to 30 minutes after the care
self-evaluation of children's pain with the visual analog scale in vertical position quote from 0 to 10, 10 represents the worst pain we can feel
次要结局
- change from baseline child's anxiety at 30 minutes after the care(-before the care -immediately after the care -15 to 30 minutes after the care)
- change from baseline heart rate at 30 minutes after the care(-before the care -immediately after the care -15 to 30 minutes after the care)
- change from baseline salivary cortisol at 30 minutes after the care(-before the care -15 to 30 minutes after the care)
- change from baseline parents' anxiety at 30 minutes after the care(-before the care - immediately after the care - 15 to 30 minutes after the care)
- evaluation of the care with satisfaction questionnaire(30 minutes after the care)
- change from baseline heart rate at 30 minutes after the care(-before the care -immediately after the care -15 to 30 minutes after the care)
- change from baseline child's anxiety at 30 minutes after the care(-before the care -immediately after the care -15 to 30 minutes after the care)
- change from baseline salivary cortisol at 30 minutes after the care(-before the care -15 to 30 minutes after the care)
- change from baseline parents' anxiety at 30 minutes after the care(-before the care - immediately after the care - 15 to 30 minutes after the care)
- evaluation of the care with satisfaction questionnaire(30 minutes after the care)