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临床试验/CTRI/2024/06/069124
CTRI/2024/06/069124尚未招募不适用

The effectiveness of origami and puzzle game in alleviating dental anxiety and pain perception during local anaesthesia administration in children: A Randomized Clinical trial

Dr P Sravya1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年6月24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
50
试验地点
1
主要终点
The primary outcome of the study is to determine the effectiveness of puzzle game with origami in reducing dental anxiety among children

研究概览

简要总结

Dental anxiety is commonly experienced among children especially during their first dental visit. This can influence their behavior and can also cause negligence of treatment, impacting their health negatively. Play therapy and good parent cooperation can minimize or reduce children’s anxiety during treatment. Origami and puzzle game are a promising, cost effective, nonpharmacological technique to reduce hospitalized anxiety and can be used to enhance intellectual and cognitive process.

Aim  To compare the effectiveness of Origami and Puzzle game as distraction techniques in reducing dental anxiety and pain in children during local anaesthesia administration.

Objectives

•      To assess the effectiveness of a puzzle game as a distraction technique in reducing dental anxiety and pain during administration of local anesthesia

•      To assess the effectiveness of an Origami as a distraction technique in reducing dental anxiety and pain during administration of local anaesthesia

•      To compare the effectiveness of a Puzzle game and Origami in reducing dental anxiety and pain during administration of local anaesthesia

Methodology  The present study will be a randomized clinical trial ,a total of 50 healthy children aged 5-10 years who require LA administration during dental procedures will be selected and they will be divided into two groups (25 in each group) using simple randomization. Group1  Puzzle game distraction technique Group2  Origami distraction technique. In both the groups, anxiety level is recorded using subjective measure (Facial image scale) ,whereas physiological measure (pulse rate by pulse oximeter) is recorded . Pain perception is recorded using objective measure (FLACC) and  using subjective measure (Faces pain scale- revised).

研究设计

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

入排标准

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

入选标准

  • Children age group of 5-10 years with no previous LA exposure Healthy children attending the dental hospital Children who are willing to participate Children indicated for dental procedures under Local anaesthesia.

排除标准

  • Children with any systemic disorders and special health care needs Children with a previous history of LA exposure Children with dental emergency which include trauma, acute pulpitis, dental abscess, cysts, pericoronitis etc.

结局指标

主要结局

The primary outcome of the study is to determine the effectiveness of puzzle game with origami in reducing dental anxiety among children

时间窗: Baseline | During administration of LA | After administration of LA

次要结局

  • The secondary outcome of the study is to determine the effectiveness of puzzle game with origami in reducing pain among children(During administration of Local anesthesia)

研究者

发起方
Dr P Sravya
申办方类型
Other [Self sponsor]
责任方
Principal Investigator
主要研究者

P Sravya

Narayana Dental College and Hospital

研究点 (1)

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