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临床试验/CTRI/2025/07/090524
CTRI/2025/07/090524尚未招募不适用

Comparison of the effectiveness of pre-treatment sensitization program and tell-show-do technique on dental anxiety of children undergoing dental treatment in their first dental visit– a randomized controlled trial

Aurthi E1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2025年7月22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
62
试验地点
1
主要终点
Change in anxiety levels as measured by

研究概览

简要总结

Children between 4 to 6 years of age reporting to the department of pediatric and preventive dentistry of Indira Gandhi Institute of Dental Sciences will be selected based on the inclusion and exclusion criteria. Randomisation will be done by computer generated numbers.Participants will be randomly assigned to two groups:

  • Group 1 (Pre-treatment sensitization program): Children will watch a pre-recorded video explaining dental procedures in child-friendly language, followed by restorative treatment.
  • Group 2 (Tell-Show-Do technique): Children will receive a verbal explanation, a demonstration of dental instruments, and then the procedure will proceed as described.

Anxiety and pulse rates will be recorded during the procedure by a blinded observer. Data will be analyzed to assess the effects of each technique on anxiety and pulse rate.

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
4.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • Children between 4-6 years of age, whose parents agreed to participate in the study.
  • Children with no history of preventive or therapeutic dental treatment.

排除标准

  • Children with special health care needs
  • Children with complaint of pain or who require emergency dental treatments.

结局指标

主要结局

Change in anxiety levels as measured by

时间窗: Pre treatment and Post treatment

- Physiological measures

时间窗: Pre treatment and Post treatment

- Anxiety scales

时间窗: Pre treatment and Post treatment

次要结局

未报告次要终点

研究者

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

Aurthi E

Indira Gandhi Institute of Dental Sciences

研究点 (1)

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