NCT07717229招募中不适用
A Comparative Evaluation of the Effectiveness of the BrightHearts Application as a Biofeedback Relaxation Tool Versus Virtual Reality Distraction in Reducing Dental Anxiety and Improving Behavior in Children During Inferior Alveolar Nerve Block Injection: A Randomized Controlled Trial
October University for Modern Sciences and Arts1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2025年11月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Evaluation of Dental Anxiety.
研究概览
简要总结
The study is designed to compare the effectiveness of "BrightHearts" biofeedback relaxation tool versus Virtual Reality distraction and Verbal distraction as a distraction methods in reducing dental anxiety and improving behavior during the inferior alveolar nerve block procedure.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children from 7 to 12 years
- •Children who have dental procedures that require an inferior alveolar nerve block injection.
- •Healthy Children.
- •Children who fall under Frankl's behavioral rating of 2 (negative) or 3 (positive)
排除标准
- •Children with special health care needs
- •Children or parents who are unable or unwilling to cooperate with the study protocol or assessment
结局指标
主要结局
Evaluation of Dental Anxiety.
时间窗: - Baseline (5 minutes before injection) - During injection - 2 minutes after injection
Using Heart rate monitor. Heart Rate (beats per minute \[bpm\]) measured using a heart rate monitor. Higher heart rate values indicate greater physiological anxiety.
次要结局
- Evaluation of Dental Anxiety(Baseline (5 minutes before injection)and immediately after injection.)
- Behavior Assessment(During injection)
研究者
Sara Ahmed Khira
Master degree candidate
October University for Modern Sciences and Arts
研究点 (1)
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