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临床试验/CTRI/2025/07/090527
CTRI/2025/07/090527尚未招募不适用

Comparative assessment of behaviour, anxiety, pulse rate, and pain perception in children using different local anesthesia delivery systems: a randomized controlled trial

Dr Sonam Yadav1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年7月21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
150
试验地点
1
主要终点
To provide positive stress free dental experience and reduces pain perception,anxiety,and aids in behavioral management

研究概览

简要总结

This study will aim to compare behaviour, anxiety, pulse rate, and pain perception in children receiving inferior alveolar nerve blocks using StarPen, Vibraject, and conventional syringes. It is expected that StarPen will demonstrate the most favorable outcomes by significantly reducing pain, anxiety, and physiological stress, while also enhancing behavioral cooperation. The findings will support the future use of electronic delivery systems like StarPen as effective tools for improving patient experience in pediatric dentistry.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

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

入选标准

  • 1.Children aged between 6 and 10 years were selected.
  • 2.Only those receiving local anesthesia for the first time were included.
  • 3.Patients requiring an Inferior Alveolar Nerve Block were considered.
  • 4.Children exhibiting Frankl’s definitely positive or positive behavior were included.

排除标准

  • 1.Patients who had previously experienced local anesthesia administration.
  • 2.Children with acute or chronic inflammation or an abscess at the injection site.
  • 3.Patients with a history of traumatic or painful dental experiences.
  • 4.Patients with underlying medical conditions or developmental anomalies.
  • 5.Children who had taken any analgesic medication in the past 24 hours.
  • 6.Patients with a known history of allergy to local anesthesia.

结局指标

主要结局

To provide positive stress free dental experience and reduces pain perception,anxiety,and aids in behavioral management

时间窗: Immediate

次要结局

未报告次要终点

研究者

发起方
Dr Sonam Yadav
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Natasha Gambhir

Santosh dental college and hospital, santosh university

研究点 (1)

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