Evaluation of the Efficacy of Camouflage Syringe in Reducing Dental Anxiety and Fear in Children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Venham's clinical rating scale
研究概览
简要总结
Dental fear and anxiety in children constitue a crucial challenge to dental care delivery as well as future behavior related to dental problems in children. A common cause of such anxiety and fear is the procedural intervention that uses needles and syringes since a visual impact due to the needle acts as a deterrent to the child's cooperation during dental procedures. We therefore improvised the syringe such that it will camouflage the needle. We hypothesized that the use of this needle will alleviate the child's anxiety and therefore will demonstrate improved outcomes related to pain, fear and anxiety. This study is a group randomized trial to test the efficacy of the camouflage syringe as compared to the conventional syringe in children.
详细描述
The present study was conducted with an aim to evaluate the efficacy of a needle-covering camouflage syringe as compared to the conventional syringe in reducing dental anxiety and fear in children. The study was carried out in 100 children who consecutively reported to the study center and were allocated to the camouflage syringe arm or conventional syringe arm using block randomization to ensure equal distribution across trial arms. The study assessed the degree of dental anxiety and fear using Venham's clinical rating scale in conjunction with rating scale for movement, crying and overall behavior and Venham's Picture Test. The study also assessed parental emotional stress status when the child underwent the injection procedure and the reaction of the child after going home by Parental Emotional Stress Questionnaire and Recall Questionnaire, respectively. The study used appropriate statistical methods to determine the efficacy of the camouflage syringe in reducing the anxiety and fear.
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
- None
入排标准
- 年龄范围
- 2 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children reporting to study center with dental problems
- •Dental procedure requiring local anesthesia
- •Informed consent from the parents
排除标准
- •Mentally challenged children
- •Medical problems negating use of local anesthesia and/or surgical intervention
结局指标
主要结局
Venham's clinical rating scale
时间窗: Within 1 hour of procedure
Venham's clinical rating scale for movement, crying and overall behavior
次要结局
- Parental Emotional Stress Questionnaire(Within 1 hour of procedure)
- Venham's Picture Test(Within 1 hour of procedure)
- Recall questionnaire(Within 2 weeks)
研究者
Shweta Ujaoney
Student Dentist
Government Dental College and Hospital, India