Comparison Of 3D Pop-Up Treatment Book Vs Virtual Educational Games In Reduction Of Pediatric Dental Anxiety During Restorative Procedures: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Behavioural response assessed using Frankl Behaviour Rating Scale
研究概览
简要总结
This randomized interventional clinical trial aims to evaluate the effectiveness of a customized 3D pop-up treatment book and a mobile-based dental care game in reducing dental anxiety and improving cooperative behaviour among children aged 4–6 years during their first dental visit. A total of 128 participants will be randomly allocated into two equal groups, each receiving one of the behavioural modification techniques before a restorative dental procedure. Anxiety levels will be assessed using Frankl Behaviour Rating Scale, Facial Image Scale, and physiological measures (heart rate and oxygen saturation) at four key intervals. The study will compare behavioural outcomes, treatment acceptance, need for additional behavioural interventions, and parental satisfaction between the two groups. The trial is supported by a research grant from Indian Council of Medical Research under Department of Health Research.
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 6.00 Year(s)（—）
- 性别
- All
入选标准
- •First dental visit of the patient Systemically healthy children.
- •Children with Frankel’s rating scale 2 or 3.
排除标准
- •Teeth with abscess, swelling or fistula at the site of injection.
- •Extensively damaged teeth.
- •Carious teeth with pre shedding mobility.
- •Teeth with lesions involving the pulp or extending below the gingiva.
- •Frankel’s rating scale 1 and
- •Medically compromised and special needs children.
结局指标
主要结局
Behavioural response assessed using Frankl Behaviour Rating Scale
时间窗: T1 before start of dental procedure baseline, T2 immediately after completion of restorative procedure
次要结局
- Physiological response heart rate & oxygen saturation using pulse oximeter & Anxiety level Facial Image Scale assessed(T1 before start of dental procedure baseline, T2 immediately after completion of restorative procedure)
研究者
ALAPATI SAI LAKSHMI SUSMITHA
MNR Dental college and Hospital