Efficacy of Active and Passive Virtual Reality Distraction During Local Anesthesia in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- dental pain
研究概览
简要总结
The aim of this study is to compare between active distraction (video game) and passive distraction (cartoon video) using a Virtual Reality ( VR ) device, in reducing injection pain and anxiety associated with local anesthesia in children.
详细描述
This comparative study is a double blinded controlled randomized clinical trial which includes 82 healthy 6-10 years old children with positive and definitely positive behavior according to Frankl Rating Scale with no known allergy to local anesthesia, no emergency dental treatment, no previous treatment from the same researcher and no previous experience in using the Virtual Reality ( VR ) device.
the participants will be allocated and treated at department of pediatric dentistry, faculty of dentistry, Tishreen university and a written consent will be obtained from the parents.
The random-numbers table will be used to divide 82 participants in to two groups:
- The active distraction group, which will be receiving the injection of local anesthesia while using the VR device with a video game and a Play Station 4 ( PS4 ) controller.
- The passive distraction group, which will be receiving the injection of local anesthesia while using VR device watching a cartoon video.
All the participants will receive an inferior alveolar nerve block with semi supine position.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
the participants will carry the controller with a box to hide the controller (to keep the outcomes assessor blinded) and wear the VR device by an assistant ( to keep investigator blinded).
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy children need a simple treatment for temporary teeth in the mandibular jaw
- •children with positive and definitely positive behavior according to frankl behavior classification
- •children with no known allergy to local anesthesia
- •children with no previous treatment from the same researcher
- •children with no previous experience in using the VR device
排除标准
- •children with negative and definitely negative behavior according to frankl behavior classification
- •children with known allergy to local anesthesia
- •children with emergency dental treatment in the mandibular jaw
- •children with previous treatment from the same researcher
结局指标
主要结局
dental pain
时间窗: Immediately after the injection of local anesthesia
self assessment pain by the children using Wong-Baker faces pain rating scale (a scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10,which represents "hurts like the worst pain imaginable" )
次要结局
- dental pain and anxiety(during the injection of local anesthesia)