Effectiveness of Audio Visual Distraction Using Virtual Reality Eyeglasses Versus Tablet Device in Child Behavioral Management During Inferior Alveolar Nerve Block
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Pain levels
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of two different audiovisual distraction techniques (Audio Video eyeglasses "VR BOX"/ Tablet) in the management of anxious pediatric patients during inferior alveolar nerve block
Group A (Control group): IAN will be administrated with basic behavior guidance techniques and without using any type of distraction aids.
Group B: IAN will be administrated with using AV eyeglasses "VR BOX" and wireless headphone.
Group C: IAN will be administrated with using tablet device and wireless headphone
All of the children who experienced an inferior alveolar block with/without distraction will be assessed by using a combination of measures: Wong-Baker FACES (self-report), pulse rate (physiological) and behavior (using FLACC behavior rating scale "external evaluator
详细描述
This study will evaluate the effectiveness of two types of distraction aids that contain video using (tablet device or VR BOX eyeglasses) and audio distraction using wireless headphone. pain and anxiety will be evaluated during inferior alveolar nerve block using three behavioral scales, Wong-Baker FACES (self-report), pulse rate (physiological) and behavior (using FLACC behavior rating scale "external evaluator".
The first measure of heart pulse rate will be recorded directly when the patient seated comfortably on the dental chair, after anesthesia, the second heart pulse rate will be taken and the child patients will ask to choose a face that describe their status from one of the Wong Baker faces scale.
For each child patient, all of the body responses will be recorded during the whole procedure and then will be evaluated by an external assessor to determine the children behavioral score according to FLACC scale.
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 (Participant)
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 6 and 10 years.
- •no previous dental experience.
- •definitely positive or positive ratings of Frank scale.
- •Need of IAN block for any dental treatment.
排除标准
- •previous dental experience
- •systematic or mental disorders.
- •definitely negative or negative ratings of Frankel scale
- •Any contraindication for regional anesthesia
研究组 & 干预措施
VR Box
Inferior alveolar nerve block will be performed with the aid of VR box as a means of distracting patients' attention.
干预措施: VR Box (Procedure)
Tablet device
Inferior alveolar nerve block will be performed with the aid of a tablet device as a means of distracting patients' attention.
干预措施: Tablet Device (Procedure)
Anesthesia
Inferior alveolar nerve block will be performed in the normal manner without any specific intervention to distract patients' attention. Classic anesthesia will be applied.
干预措施: Anesthesia (Drug)
结局指标
主要结局
Pain levels
时间窗: five minutes following the inferior alveolar nerve block injection.
using self-reported Wong-Baker FACES pain scale with 0 indicating 'no pain' and five indicating 'worst pain'.
Anxiety levels
时间窗: Within the first minute of injecting the needle into the oral mucosa (oral tissues).
This will be evaluated using the Face-Legs-Activity-Cry-Consolability (FLACC) scale employing an external evaluator in which all of the body responses will be recorded once the needle penetrate the oral tissue. (0 low anxiety and pain level - 10 high anxiety and pain level)
Change in physiological pulse rate
时间窗: (1) five minutes after the patient is seated comfortably on the dental chair, (2) five minutes following the injection of the anesthetic drug
using Finger Pulse Oximeter
次要结局
未报告次要终点