Comparative Evaluation of Effectiveness of Sensory Adapted Dental Environment and Regular Dental Environment to Alleviate Anxiety in Children Undergoing Dental Treatment: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Measurement of preoperative and postoperative anxiety using Venhams Picture Scale and Pulse rate
研究概览
简要总结
The Principal Investigator will perform the procedure under Standard Operating Protocols. The procedure will be carried out in 45 min for each patient in all the two groups. Parental consent and patient assent will be obtained. The patient will be first asked to sit comfortably on the dental chair. Case History of the patient and preoperative anxiety scores will be noted using Venham’s Picture Scale and Pulse Oximeter. The operator (principal investigator) will be then perform restorative treatment in sensory adapted and regular dental environment. Selected tooth will be isolated with rubber dam and class I cavity preparation using appropriate armamentarium will be done. After which the cavity will be restored using a suitable material. Post restorative instructions will be given. The sensory adapted dental environment is a specialized environment which will aim to activate all the 5 senses of human body to reduce dental anxiety. The setup will consist of moving ceiling light (visual stimulation), portable speaker with soothing music (auditory stimulation), air diffusers with aromatic oils (olfactory stimulation), stress balls or hugging toys (tactile stimulation) and flavoured runner dam sheets (gustatory stimulation). The regular setup will consist of no such specifications.
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 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children between 6-12 years of age.
- •Children visiting dental clinic for the first time.
- •Children with caries extending up to superficial dentin requiring Class 1 restoration in primary/ permanent molar teeth.
- •Children and/or parents who are willing to participate in the study.
排除标准
- •Children with special health care needs.
- •Children and/or Parents who are unwilling to participate in the study.
- •Parents of children who insist on being in the operatory shall be excluded from the study to avoid parental influence on child.
结局指标
主要结局
Measurement of preoperative and postoperative anxiety using Venhams Picture Scale and Pulse rate
时间窗: Baseline and Post operative
次要结局
未报告次要终点
研究者
Dr Varunika V Sahai
KAHERs KLE VK Institute of Dental Sciences, Belagavi