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临床试验/CTRI/2025/07/090509
CTRI/2025/07/090509尚未招募3 期

Comparative Evaluation Of Distraction Cards, Virtual Reality Glasses And Precooling Vibrating Device As Distraction Methods In Children During Administration Of Inferior Alveolar Nerve Block- A Randomized Control Trial.

Deepshikha Behera1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
160
试验地点
1
主要终点
The effectiveness of distraction cards, virtual reality glasses and precooling vibrating devices in reducing anxiety levels, pain perception and improving behavior during inferior alveolar nerve block.

研究概览

简要总结

The study will use distraction methods in children of age 4-8 years requiring administration of inferior alveolar nerve block. Distraction cards, virtual reality glasses and precooling vibrating device will be used as distraction methods. By using this distraction method anxiety levels, behavior and pain perception will be assessed by Modified Child Dental Anxiety Scale (MCDAD(f)); Venham’s Behavior Rating Scale; Face, Legs, Activity, Cry, Consolability Scale (FLACC); Wong Baker FACES Pain Rating Scale (WBFPRS) will be used prior to  and during local anesthesia administration.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
4.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Children aged 4-8 years requiring routine dental procedure to be carried out under inferior alveolar nerve block.
  • Children who Children had not received local anesthesia before.
  • Children not allergic to topical anesthesia.
  • Presence of pulpaly involved teeth where need of extraction or pulpal therapy necessisating a nerve block.
  • No history of systemic illness.

排除标准

  • Children who had previously received local anesthesia.
  • Children who presented with a history of chronic illness.
  • Children who required treatment under sedation / general anesthesia.
  • Visual, audio or speech impairments.
  • Children allergic to local anesthesia.

结局指标

主要结局

The effectiveness of distraction cards, virtual reality glasses and precooling vibrating devices in reducing anxiety levels, pain perception and improving behavior during inferior alveolar nerve block.

时间窗: During inferior alveolar nerve block procedure.

次要结局

  • Comparison of anxiety levels, pain perception & behavior during inferior alveolar nerve block using distraction card, virtual reality glasses & precooling vibrating device(Before & After admistration of inferior alveolar nerve block.)

研究者

发起方
Deepshikha Behera
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Deepshikha Behera

Surendera Dental College and Research Institute

研究点 (1)

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