Effectiveness of simulated breathing musical soft toy in alleviating dental anxiety during restorative procedures in 4-8-year old children: a randomized clinical trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To evaluate the effectiveness of a simulated breathing musical soft toy in reducing anxiety during dental restorative procedures in children aged 4–8 years.
研究概览
简要总结
This randomized clinical trial is aimed at assessing the efficacy of a simulated breathing musical soft toy in reducing dental anxiety in children aged 4 to 8 years during restorative dental procedures. Participants will be randomly assigned to either an intervention group, in which the child uses a simulated-breathing musical soft toy during treatment, and a control group, in which the child receives only standard behavior management. Dental anxiety will be measured with validated behavioral measures and physiological markers such as heart rate. The study aims to examine if this convenient, non-pharmacological distraction strategy will increase cooperation and reduce anxiety in dental patients.
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
- 4.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •The study includes healthy children aged 4–8 years who had no prior dental experience, presented with ICDAS scores of 1, 2, or 3, and exhibited Frankl’s behavior rating of 2 and 3.
排除标准
- •Children with known anxiety disorders
- •Medically compromised
- •Past dental history.
结局指标
主要结局
To evaluate the effectiveness of a simulated breathing musical soft toy in reducing anxiety during dental restorative procedures in children aged 4–8 years.
时间窗: 2nd visit
次要结局
- To evaluate the acceptance of a simulated-breathing musical soft toy in children aged 4 to 8 years.(2nd visit after treatment)
研究者
Mohini Anil Pawshekar
Ranjeet Deshmukh Dental College and Research Center