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临床试验/NCT03566212
NCT03566212已完成不适用

Clinical Comparative Study of Efficacy of Camouflaged Syringe vs Conventional Syringe in Reducing Dental Anxiety

Sneha D. Suwarnkar2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年8月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Anxiety levels by using the Chotta Bheem and Chutki scale

研究概览

简要总结

This study evaluates the efficacy of Camouflage syringe vs Conventional syringe in reducing Dental Anxiety and increasing behaviour rating.Half of the participants received local anesthesia using camouflaged syringe, while others received using conventional syringe.

详细描述

Dental anxiety and phobia result in avoidance of dental care. Since the injection itself can be painful, pain reduction procedures warrant continued investigation. Camouflage design deals with the visual impact of the needle and syringe though the tactile sensation remains unaltered. In our study, post treatment anxiety levels in camouflaged syringe was reduced as compared to conventional syringe group and this might be because, patients with low anxiety tend to have high pain thresholds.

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
3 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • retained teeth,
  • badly carious teeth,
  • mobile teeth
  • requiring a dental procedure under local anesthesia were selected.

排除标准

  • Mentally challenged children
  • those with medical conditions contraindicating the use of local anesthesia and / or surgical procedures

研究组 & 干预措施

conventional syringe

Experimental

Individuals requiring local anesthesia for dental treatment were treated in first group by using conventional syringe.

干预措施: Conventional Syringe (Device)

camouflaged syringe

Experimental

Individuals requiring local anesthesia for dental treatment were treated in second group by using camouflage syringe.

干预措施: Camouflage Syringe (Device)

结局指标

主要结局

Anxiety levels by using the Chotta Bheem and Chutki scale

时间窗: after 5 minutes

Anxiety levels in both camouflaged group and conventional group in the children were scored before and after the procedure using the Chotta Bheem and Chutki scale. The Chotta Bheem and Chutki (CBC) scale comprises two separate cards: one for boys and the other for girls. The cartoon characters of Chotta Bheem and Chutki were chosen to depict various emotions for boys and girls respectively. Each card consists of a series of six figures depicting sequentially various emotions from 'happy' to 'unhappy and running away' of the cartoon character. Score 1 is happy face, score 2 is sad face, score 3 is crying face, score 4 is angry face, score 5 is shouting and score 6 is running. So, here, score 1 depicts patient is happy whereas as score increases anxiety level also increases which denotes that patient is unhappy.

次要结局

  • Behavior rating by using Frankel Behaviour rating scale(after 10 minutes)

研究者

发起方
Sneha D. Suwarnkar
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sneha D. Suwarnkar

Principal investigator

Saraswati-Dhanwantari Dental College & Hospital

研究点 (2)

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