Effectiveness of distraction cards in reducing anxiety and pain perception during restorative treatment in 6-8-year-old children—a randomized controlled trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate change in anxiety and pain perception while using distraction cards as
研究概览
简要总结
This randomized controlled trial will determine whether distraction cards will reduce anxiety and pain perception in 6- to 8-year-old children during restorative dental treatment. Children will be randomly randomized to either distraction cards (presented before and during the procedure) or usual care, and investigators will measure their behavioral and self-reported responses during treatment. It is expected that the distraction-card group will have lower anxiety and discomfort levels than the controls. The study anticipate that distraction cards are a simple, low-cost, and effective behavioral tool for lowering distress during pediatric restorative procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with ICDAS scores of 3 to 5 who exhibited Frankel’s behavior ratings of 3 or 4 during dental procedures were included.
排除标准
- •Children with severe caries potentially involving the pulp, who are medically compromised and have a relevant past dental history.
结局指标
主要结局
To evaluate change in anxiety and pain perception while using distraction cards as
时间窗: Baseline (pre-intervention): Day 0, before procedure | Immediate post-intervention: Day 0, within 30 minutes
compared to traditional behavior management techniques for 6-8-year-old children during their restorative treatment.
时间窗: Baseline (pre-intervention): Day 0, before procedure | Immediate post-intervention: Day 0, within 30 minutes
次要结局
未报告次要终点
研究者
Mohini Anil Pawshekar
Ranjeet Deshmukh Dental College and Research Center