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临床试验/CTRI/2024/05/066902
CTRI/2024/05/066902尚未招募2/3 期

Comparative evaluation of two different distraction techniques in dental anxiety and pain during maxillary infiltration and inferior alveolar nerve block administration among 6-11year old children

Dr Mary Grace1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年5月20日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To reduce anxiety in children during local anesthetic administration

研究概览

简要总结

The present study is a comparative randomized crossover clinical trial conducted in vivo.  This study was performed to assess the effectiveness of two different distraction techniques such as audio visual aids and virtual reality eye glasses during local anesthetic administration in children prior to their dental treatment. The children are divided into four groups each group had equal number of children based the frankl’s behavior rating scale (positive / negative). Group 1 and 2 children included children requiring bilateral maxillary posterior infiltrations while group 3 and 4 included children in need of bilateral inferior alveolar nerve block administration. The primary outcome of the study is to decrease anxiety and fear in children and to maintain a positive behavior of the child throughout the procedure. This study has 2 dental visits. During the first visit if the child is subjected to Audio visual aids the same child will be subjected to virtual reality eyeglass in its second visit. The anxiety, behaviour and pain will be assessed to different methods such as FLACC scale, Iowa pain thermometer-revised and pulse oximeter is used to measure the pulse rate of the child throughout the procedure

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
6.00 Year(s) 至 11.00 Year(s)(—)
性别
All

入选标准

  • Children displaying both positive and negative ratings according to Frankl behavior rating scale Requirement for any dental treatment necessitating bilateral local anesthetic administration within a single arch Consent obtained from childrens parents.

排除标准

  • Children with prior exposure of local anesthesia administration Patients with medically or developmentally compromising conditions like epilepsy, photo sensitivity etc Patients with mental or cognitive impairments Children with language barriers Children with known allergies to local anesthetic agents.

结局指标

主要结局

To reduce anxiety in children during local anesthetic administration

时间窗: The patient was assessed in 2 dental visits in a time gap of 2 weeks and the baseline, during procedure and after procedure values are noted

次要结局

  • To reduce anxiety & to increase the cooperativeness of child during dental treatment(The patient was assessed in 2 dental visits in a time gap of 2 weeks & the baseline, during procedure & after procedure values are noted)

研究者

发起方
Dr Mary Grace
申办方类型
Other [Dr Ashok Kumar]
责任方
Principal Investigator
主要研究者

Mary grace

Madha dental college and hospital

研究点 (1)

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