跳至主要内容
临床试验/CTRI/2024/02/062828
CTRI/2024/02/062828尚未招募3 期

Evaluation of Different Methods of Assessment of Anxiety in Pediatric Patients

Dr Aishwarya Savakiya1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2024年2月27日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
112
试验地点
1
主要终点
To determine the validity and reliability of galvanic skin response as a objective measure for assessment of dental anxiety in children.

研究概览

简要总结

112 children will be divided into four groups. Four measurements will be taken before and after the local anaesthesia administration. Four measurements are the Modified Child Dental Anxiety Scale (MCDAS) as a self-report scale (18), the Clinical Anxiety Rating Scale (CARS) as a behavioural scale (19), pulse rate and oxygen saturation for physiological evaluation and Galvanic skin response (GSR) for psychophysiological evaluation of dental anxiety.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
5.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • children demonstrated positive or definitely positive behavior (frakle 3 or 4 behaviour rating scale) Child’s first dental treatment under local anaesthesia.
  • Child without any medical and systemic condition.

排除标准

  • children demonstrated negative or definitely negative behavior (frakle 3 or 4 behaviour rating scale) Children without previous dental experience of Local anesthesia child with any medical and systemic condition.

结局指标

主要结局

To determine the validity and reliability of galvanic skin response as a objective measure for assessment of dental anxiety in children.

时间窗: 4 months

次要结局

  • To evaluate the effects of two different distraction technique using mini digital camera and hand puzzle on reduction of anxiety during administration of local anesthesia in children.

研究者

发起方
Dr Aishwarya Savakiya
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Aishwarya Savakiya

College of Dental Sciences and Research Centre

研究点 (1)

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