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临床试验/CTRI/2022/01/039554
CTRI/2022/01/039554已完成不适用

Comparative evaluation of anxiety levels and pain perception during local anaesthesia administration using conventional syringe, insulin syringe and deception needle in 6–12 year-old children

Department of Pediatric and Preventive Dentistry1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2022年1月21日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
1
主要终点
Reduction in Anxiety Levels

研究概览

简要总结

A child’s emotional and behavioral response to dental treatment has been a matter of concern for pediatric dentists since decades. Child’s uncooperative or unmanageable behavior can impede the efficient delivery of dental care and can compromise the quality of treatment being rendered. If not adequately resolved, a persistent negative behavior pattern can hamper the future dental health of a child. A vicious cycle can be observed in relation to dental fear and anxiety wherein fear directly leads to avoidance of dental visits which results in detrition of oral health, which further leads to a more problem oriented dental visit and exacerbation of the level of dental fear.1 Hence, presence of dental fear and anxiety can be a major obstacle in the delivery of quality dental services.

 Dentistry as a branch has an environment which can elicit anxiety in children. Various studies have concluded that injections are one of the most fear-provoking stimuli in dentistry.2,3 This also pertains to the fact that children are exposed to injections a multiple number of times since they undergo vaccinations from infancy to childhood. However, a profound local anesthesia ensures a successful treatment of pediatric patients in terms of alleviating their anxiety and discomfort during restorative and surgical procedures.4Due to its ample use in the field of paediatric dentistry, a painless administration of injection would in turn lead to good behavior from the patient in the future.

 The application of local anaesthesia has always been a difficult task since children perceive it to be threatening both visually and psychologically. Thus, an anxious patient might perceive more severe pain of longer duration than would a less anxious patients.5In an attempt to improve patient comfort during local anaesthetic administration, use of topical agents, precooling the injection site, use of fine needles, buffering and warming the local anaesthesia, distraction techniques, vibrating devices and slow computer-regulated administration are some of the widely used techniques.

 One of the most convenient practice is to use an insulin syringe which is smaller in size, colourful, and less frightening than the usual conventional syringes. Another alternative method can be masking the conventional needle by showing children disposable plastic tips before the administration and eventually using the conventional needles by keeping them hidden from their sight.

When literature search was carried out, it showed that few studies have been conducted which compared the conventional syringes with insulin syringes. However, no study has been conducted which involves the use of a deception needle by showing the patient disposable obturation tips and eventually using the conventional syringe for administration of Local anaesthesia. Hence, this study was planned to evaluate the anxiety levels and pain perception in children during local anaesthesia administration by comparing conventional syringe, insulin syringe and deception needle.

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 Blinded

入排标准

年龄范围
6.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Children between the age group of 6-12 years.
  • Children who require infiltration anaesthesia in the maxillary arch for restorative, pulp therapy or extraction work.
  • Children who have never experienced dental injection.
  • Patients who are willing to undergo treatment.

排除标准

  • Children with systemic diseases and special health care needs.
  • Patients allergic to contents of local anaesthesia.
  • Patients who require emergency treatment.

结局指标

主要结局

Reduction in Anxiety Levels

时间窗: Pre and Post Intervention

次要结局

  • Pain Perception(Post Intervention)

研究者

发起方
Department of Pediatric and Preventive Dentistry
申办方类型
Research institution and hospital

研究点 (1)

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