Evaluating Acceptance and Efficacy of an Eye Massage Device in Reducing Pain and Anxiety During Dental Anesthesia in Children.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Pain levels
研究概览
简要总结
This study aims to evaluate the effectiveness and acceptance of an eye massage device that produces nature sounds and vibratory stimulations in the management of anxious pediatric patients during inferior alveolar nerve block
Group A (Control group): inferior alveolar nerve block will be administrated with basic behavior guidance techniques and without distraction aids.
Group B: inferior alveolar nerve block will be administrated with the usage of the eye massage device producing both vibrations and nature sounds
Group C: inferior alveolar nerve block will be administrated with the eye massage device producing vibratory stimulations only.
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 and the Children's Fear Scale (self-report), heart pulse rate and blood pressure (physiological), and behavior (using Anxiety levels using Face - Legs - Activity - Cry - Consolability "FLACC" scale "external evaluator") Acceptance will be measured using a two-point Likert scale.
详细描述
This study will evaluate the effectiveness and acceptance of a distraction aid that produces both vibratory and natural sound stimulations. pain and anxiety will be assessed during inferior alveolar nerve block using four behavioral scales, Wong-Baker pain scale and Children's Fear Scale (self-report), pulse rate and blood pressure (physiological), and behavior (using FLACC behavior rating scale "external evaluator".
Heart pulse rate measurement will be recorded firstly when the patient is seated comfortably on the dental chair, during anesthesia, and finally, after the procedure is done and the child patients will be asked to choose a face that describes their status from one of both Wong Baker faces scale and Children's Fear Scale.
Blood pressure will be recorded before, during, and after anesthesia. Body responses of all child patients will be recorded during the whole procedure and then will be evaluated by an external evaluator to determine the children's behavioral score according to the 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 (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age between 7 and 9 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
结局指标
主要结局
Pain levels
时间窗: 5 minutes following the inferior alveolar nerve block injection.
Pain levels will be measured by using a self-reported simplified Wong-Baker faces pain scale: 0 no Hurt - 1 Hurts little Bit - 2 Hurts little More - 3 Hurts Even More - 4 Hurts Whole Lot - 5 Hurts Worst
Anxiety levels
时间窗: five minutes following the inferior alveolar nerve block injection
This will be evaluated using Children's Fear Scale (0 indicating 'no anxiety' and 4 indicating 'extreme anxiety').
次要结局
- Pulse rate((1) five minutes after the patient is seated comfortably on the dental chair, (2) five minutes following the injection of the anesthetic drug)
- Blood pressure((1) five minutes after the patient is seated comfortably on the dental chair, (2) five minutes following the injection of the anesthetic drug)