跳至主要内容
临床试验/NCT07075458
NCT07075458已完成不适用

Effectiveness Of Magic Tricks Distraction Technique In Reducing Anxiety In 3-7 Years-Old Children During Local Anesthesia Administration

Mansoura University2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2024年4月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
102
试验地点
2
主要终点
Change in dental anxiety level as measured by RMS-PS (Raghavendra, Madhuri, and Sujata Pictorial Scale)

研究概览

简要总结

Dental anxiety among children is a significant challenge in pediatric dentistry, often hindering effective dental care. This clinical study aims to evaluate the effectiveness of two magic tricks distraction techniques (magic rope and magic thumb sleeves) in reducing dental anxiety among children aged 3-7 years during local anesthesia administration, in comparison to the conventional Tell-Show-Do (TSD) technique. Anxiety will be measured using the Raghavendra, Madhuri, and Sujata Pictorial Scale (RMS-PS) and pulse oximeter for heart rate assessment

详细描述

Dental anxiety in children poses a persistent challenge in pediatric dental practice, often leading to behavioral management difficulties, compromised treatment outcomes, and long-term avoidance of dental care. One of the most anxiety-inducing procedures for young patients is the administration of local anesthesia (LA), primarily due to fear of needles, unfamiliar instruments, and perceived pain. Traditional behavioral management techniques such as the Tell-Show-Do (TSD) method have been widely used to familiarize children with the dental setting and reduce procedural anxiety. However, the effectiveness of TSD during high-stress interventions like LA injections remains under debate, especially among younger children with limited cognitive development.

In response to the need for more engaging and effective behavior guidance strategies, distraction-based techniques-particularly those involving visual and interactive elements-have gained increasing interest. Among them, thaumaturgy, or the use of magic tricks, has emerged as a novel, non-pharmacological method for anxiety reduction in pediatric patients. Magic-based interventions are believed to captivate the child's attention, stimulate curiosity, and shift focus away from the source of fear, thereby promoting relaxation and behavioral cooperation.

This randomized controlled clinical trial is designed to evaluate the efficacy of two magic trick-based distraction techniques-the magic rope and magic thumb sleeves-in reducing dental anxiety in children aged 3 to 7 years, during the administration of local anesthesia. The intervention groups will be compared to a control group managed with the conventional TSD technique.

To ensure a comprehensive and objective assessment of anxiety, the study will employ a dual-modal evaluation approach:

Subjective measurement using the Raghavendra, Madhuri, and Sujata Pictorial Scale (RMS-PS), which is specifically validated for young children and uses gender-specific real-life facial photographs to help participants express their emotional states accurately.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

盲法说明

This is an open-label study; neither participants nor investigators are blinded to the intervention assignment.

入排标准

年龄范围
3 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children in the age group of 3 to 7 years old.
  • Children without any past dental treatment experience under local anesthesia.

排除标准

  • Children with a systemic diseases.
  • Children with an extreme disruptive behavior.
  • Children with acute dental pain or swelling.
  • Children with problems in their intellectual functions.

结局指标

主要结局

Change in dental anxiety level as measured by RMS-PS (Raghavendra, Madhuri, and Sujata Pictorial Scale)

时间窗: Immediately after local anesthesia administration at the same visit

Dental anxiety will be assessed using the RMS-PS scale immediately after local anesthesia administration.

heart rate using pulse oximeter

时间窗: periprocedural

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Effectiveness Of Magic Tricks Distraction Technique | 临床试验