The Effect of Augmented Reality Versus Virtual Reality Glasses as Distraction Techniques in Children During the Administration of Local Anesthesia A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evaluation of pain perception and anxiety before and after local anesthesia administration using augmented reality glasses in 5-8-year-old children
研究概览
简要总结
The goal of this clinical trial is to learn if audio-visual method of distraction is useful to control the pain and fear associated with dental treatment in children. The main questions it aims to answer are:
• How their body reacts-such as changes in heart rate, oxygen levels, and certain chemicals in their saliva-before and after getting local anesthesia? Researchers will test two types of glasses that display cartoons to help children feel less anxious.
Participants will:
- Have an introductory visit to be more familiar with dental environment and their cooperation will be tested.
- In the next 2 visits they will wear either of the glasses while receiving local anesthesia
- Saliva will be collected, and their heart rate and oxygen levels will be calculated each time
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The main supervisor will code the patients' tooth allocation in order to blind the statistician and the clinical pathologist who will assess the salivary biomarker levels in the samples.
入排标准
- 年龄范围
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •5-8 year-old female and male patients.
- •Cooperative patients (rating 3 or 4 on the Frankl's Behavior Rating Scale).
- •American Society of Anesthesiologists (ASA) Class (I).
- •Patients need dental treatment under local anesthetic infiltration.
- •Patients without known anxiety disorders.
- •Patients with body weight that is considered normal according to their age and gender (95th percentile growth curve).
- •Patients without a prior history of receiving local anesthetic.
- •Patients with at least one vital primary molar with deep carious lesion on each side of the dental arch, who require to be treated under local anesthesia
排除标准
- •Patients with special health care needs.
- •Patients on corticosteroid medications.
- •Patients having known salivary disorders, such as Sjogren's syndrome.
- •Parents who refused to sign the informed consent.
研究组 & 干预措施
Maxillary right primary molars
In this Split-mouth Randomized Controlled Trial, 5-8-year-old female and male children will be enrolled. They will receive local anesthesia on the right side of the arch using one of the distraction methods, then after one to two weeks they will receive local anesthesia on other side of the arch using a different distraction method
干预措施: Augmented Reality Glasses (Device)
Maxillary right primary molars
In this Split-mouth Randomized Controlled Trial, 5-8-year-old female and male children will be enrolled. They will receive local anesthesia on the right side of the arch using one of the distraction methods, then after one to two weeks they will receive local anesthesia on other side of the arch using a different distraction method
干预措施: Virtual Reality Glasses (Device)
Maxillary left primary molars
In this Split-mouth Randomized Controlled Trial, 5-8-year-old female and male children will be enrolled. They will receive local anesthesia on the left side of the arch using one of the distraction methods, then after one to two weeks they will receive local anesthesia on other side of the arch using a different distraction method
干预措施: Augmented Reality Glasses (Device)
Maxillary left primary molars
In this Split-mouth Randomized Controlled Trial, 5-8-year-old female and male children will be enrolled. They will receive local anesthesia on the left side of the arch using one of the distraction methods, then after one to two weeks they will receive local anesthesia on other side of the arch using a different distraction method
干预措施: Virtual Reality Glasses (Device)
结局指标
主要结局
Evaluation of pain perception and anxiety before and after local anesthesia administration using augmented reality glasses in 5-8-year-old children
时间窗: Pain perception will be assessed from needle insertion to completion of injection (1 minute) of local anesthesia.
The face, legs, activity, cry, consolability (FLACC) behavioral pain assessment scale will be used to objectively assess the pain perception during local anesthetics administration, this scale consists of 5 categories, each category is scored from 0 to 2, with a total score ranging from 0 ("relaxed and comfortable") to 10 ("sever discomfort or pain or both").
Evaluation of pain perception and anxiety before and after local anesthesia administration using augmented reality glasses in 5-8-year-old children
时间窗: Pain perception will be assessed immediately before, and immediately after local anesthetics administration.
The Wong-Baker FACES Pain Rating Scale Arabic Version, will be used to subjectively assess the pain perception before and after local anesthetics administration, the scale uses cartoon faces representing pain levels from 0 ("no pain") to 10 ("worst pain imaginable").
次要结局
- Changes in the levels of the salivary cortisol, of 5-8-year-old children before and after the administration of local anesthesia using augmented reality glasses as a distraction(Salivary stress biomarker will be assessed at baseline, and 20 minutes after local anesthetics administration while the child is distracted using either augmented reality glasses or virtual reality glasses.)
- Changes in the levels of the salivary alpha amylase, of 5-8-year-old children before and after the administration of local anesthesia using augmented reality glasses as a distraction(Salivary stress biomarker will be assessed at baseline, and 20 minutes after local anesthetics administration while the child is distracted using either augmented reality glasses or virtual reality glasses.)
- Changes in the heart rate of 5-8-year-old children before, during, and after the administration of local anesthesia using either augmented or virtual reality glasses as a distraction(Heart rate and oxygen saturation will be assessed at baseline, at the onset anesthesia administrating, and one minute after local anesthetics administration while the child is distracted using either augmented reality glasses or virtual reality glasses)
- Changes in the oxygen saturation of 5-8-year-old children before, during, and after the administration of local anesthesia using either augmented or virtual reality glasses as a distraction(Oxygen saturation will be assessed at baseline, at the onset anesthesia administrating, and one minute after local anesthetics administration while the child is distracted using either augmented reality glasses or virtual reality glasses)
研究者
Riham Abbas
General practitioner
Ain Shams University