跳至主要内容
临床试验/CTRI/2024/06/069499
CTRI/2024/06/069499尚未招募1/2 期

Effectiveness of a Novel distraction technique versus Eye movement distraction technique on pain perception and anxiety during Local anesthesia administration in children : A Randomized Clinical Trial.

Dr KS Praveena1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年7月18日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
To determine the effectiveness of Writing in the air using leg distraction and Eye movement distraction in reducing dental anxiety among children

研究概览

简要总结

Successful LA administration is important for many pediatric dental procedures. Administration of LA itself is painful and anxiety –evoking, which can negatively influence the behavior of the child. Hence, treating pediatric patients with minimal distress and pain has become a predominant objective for every pediatric dentist.

Distraction is the technique of diverting the patient’s attention from what maybe perceived as an unpleasant procedure. Distraction techniques addresses psychological components of pain by diverting the focus of the child from anxiety – provoking procedures.

Aim To evaluate the effectiveness of a novel distraction and eye movement distraction technique on pain perception and anxiety during LA administration in children aged 7-11 years.

Objectives

To assess the effect of WITAUL distraction technique in reducing dental anxiety and pain during LA administration.

To assess the effect of Eye movement distraction in reducing dental anxiety and pain during LA administration.

To compare the effectiveness of WITAUL distraction and eye movement distraction during LA administration.

Methodology

The present study will be a randomized clinical trial using simple random sampling. A total of 50 healthy children aged 7-11 years who require local anesthesia administration during dental procedure will be included in the study and they will be divided into two groups.

Group 1  Writing in the air using leg distraction group

Group 2  Eye movement distraction group

In both the groups , anxiety levels will be recorded using physiological measure i.e., Pulse Oximeter ( before , during and after LA) and subjective measure by visual analogue scale ( before and after LA).

Pain perception will be recorded during LA administration by FLACC scale and after LA administration by Wong-Baker pain scale.

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
7.00 Year(s) 至 11.00 Year(s)(—)
性别
All

入选标准

  • Children age group of 7-11years who require local anesthesia administration during dental procedures.
  • Children with no previous dental treatment experience.

排除标准

  • Any medically and physically compromised children.
  • Children who do not require local anesthesia in any treatment procedure.
  • Those who are not willing to participate in the study.

结局指标

主要结局

To determine the effectiveness of Writing in the air using leg distraction and Eye movement distraction in reducing dental anxiety among children

时间窗: At baseline, during local anesthesia administration and after local anesthesia administration

次要结局

  • To determine effectiveness of writing in the air using leg distraction & Eye movement distraction in reducing pain among children.(At baseline, during Local Anesthesia administration & after local anesthesia administration)

研究者

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

DrKSPraveena

Narayana Dental College and Hospital

研究点 (1)

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