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临床试验/CTRI/2018/10/016198
CTRI/2018/10/016198尚未招募不适用

Comparing the conventional syringe with camouflage syringe by evaluating behavior and anxiety in 6 -10 year old children while administering local anesthesia – A cross over trial with split mouth study design

Padminee Krishnan1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年10月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Heart Rate, Oxygen saturation

研究概览

简要总结

Dental fearand anxiety are widely prevalent among children deteriorating their cooperationduring dental procedures. One major cause for dental fear and anxiety is theprocedural intervention with needles and syringes. The visual impact created onthe sight of the needle deters the child’s cooperation towards the treatment.Hence in the current study, the use of camouflage syringe was compared withconventional syringe by assessing the behavior and anxiety of the child.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Investigator Blinded

入排标准

年龄范围
6.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • 1.Children with no past dental experience 2.Children with no medical complications 3.Children who require treatment under Local anesthesia in 2 different quadrants 4.Children and parent willing to participate in the study.

排除标准

  • 1.Children with special health care needs’ 2.Children allergic to local anesthesia 3.Children who require treatment under local anesthesia in only one quadrant 4.Children and parents who are not willing to participate.

结局指标

主要结局

Heart Rate, Oxygen saturation

时间窗: Using Pulse oximeter before, during and after intervention

次要结局

  • FLACC score -Face, Legs, Activity, Cry and Consolability(During administration of local anesthesia)

研究者

发起方
Padminee Krishnan
申办方类型
Other [self funded]

研究点 (1)

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