Comparison of anxiety level during treatment and subsequent visit between two different protocols of nitrous oxide-oxygen sedation and conventional behavior management in 6 to 12 year old children - a randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Venham’s clinical anxiety scale: A pre-validated 6 point scale.
研究概览
简要总结
In our study we plan to assess and compare
- the overall average anxiety level in 6 to 12 year old children who receive dental treatment under two different protocols of nitrous oxide-oxygen sedation and conventional behavior management techniques.
2) the anxiety level in 6 to 12 year old children who receive dental treatment under two different protocols of nitrous oxide-oxygen sedation and conventional behavior management techniques on three different visits.
- To compare anxiety level of children in the first treatment visit to anxiety level in the subsequent visit in all the groups.
Our proposed primary research hypothesis is nitrous oxide-oxygen sedation can reduce anxiety levels in 6 - 12 year old children compared to the conventional behavior management techniques in treatment and subsequent visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA category 1 children aged 6-12 years.
- •Children with CFSS –DS score above 32, indicative of moderate to high dental anxiety.
- •Children requiring at least one procedure which requires LA administration and one restoration.
排除标准
- •Children suffering from any conditions which may hinder their participation.
- •Children with limited cognitive abilities (cognitive impairment/intellectual disability)
- •Children whose parents refuse to give consent.
结局指标
主要结局
Venham’s clinical anxiety scale: A pre-validated 6 point scale.
时间窗: Anxiety assessment will be done at the first visit that is baseline and after one week and after two weeks
Self-reported anxiety levels will be measured using Children’s fear survey schedule-Dental Subscale (CFSS-DS): 15 items rated on 5 point scale, ranging from 1 (not afraid) to 5 (very afraid). The total score is calculated by summing item score.
时间窗: Anxiety assessment will be done at the first visit that is baseline and after one week and after two weeks
Observer rating of behavior will be measured using
时间窗: Anxiety assessment will be done at the first visit that is baseline and after one week and after two weeks
Facial image scale: A pre-validated 5 point scale.
时间窗: Anxiety assessment will be done at the first visit that is baseline and after one week and after two weeks
Global rating scale: A pre-validated 5 point scale.
时间窗: Anxiety assessment will be done at the first visit that is baseline and after one week and after two weeks
次要结局
- Acceptability of nitrous oxide-oxygen sedation: will be assessed by likert scale: 3 point categorical scale(Acceptability assessment will be done at the end of the visit that is baseline and one week after and two week after baseline)