Comparison of Anxiety & Stress levels in pre & post Inhalational sedation & Non-pharmacological technique in children – A Randomized Cross Over Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To decrease anxiety and stress level
研究概览
简要总结
• 40 children of age group 4-13 years, who reported to the department of pediatric and preventive dentistry were selected depending upon the inclusion criteria.
Children were assigned into two equal groups (n=20). The principal investigator performed the randomization process before beginning the study
Group A. (The conscious sedation group) 20 children were sedated by the rapid induction method by means of Nitrous oxide oxygen gas (inhalational)
Group B. 20 children will receive the treatment by conventional behavior management techniques. Pre and post anxiety levels were recorded with venham clinical anxiety scale and heart rate and spo2 levels by connecting the monitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
入排标准
- 年龄范围
- 4.00 Year(s) 至 13.00 Year(s)（—）
- 性别
- All
入选标准
- •Children falling under ASA I & ASA II category Exhibiting moderate to severe anxiety.
- •Absence of mental retardation, no history drug therapy Presence of at least two primary molars requiring the treatment.
排除标准
- 未提供
结局指标
主要结局
To decrease anxiety and stress level
时间窗: 4 weeks
次要结局
- Decreased anxiety & stress level in participants(8 weeks)
研究者
Dr Rashmi Chour
Room number 9 Department of pedodontics PMNM dental college and hospital Bagalkot