Comparative evaluation of different audio distraction therapies during extraction procedures in children- A Randomised Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Satisfactory effectiveness of music as an audio distraction therapy during simple extraction procedures in children.
研究概览
简要总结
This study is a randomized, single-blinded, single-centre trial comparing the effectiveness of four types of audio distraction therapies/techniques during simple extraction procedures in children in the age group of 6-10 years in the Department of Pediatric and Preventive Dentistry, MAIDS. The primary outcome will depict the satisfactory effectiveness of music as an audio distraction therapy during simple extraction procedures in children. It will be evaluated at three points, ie., preoperatively, during LA administration and during extraction procedure. The need for this study arises from the lack of comprehensive data comparing these types of audio distraction therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Children in the age group of 6 to 10 years.
- •Children having primary teeth indicated for extraction.
排除标准
- •Children with any Special Health Care needs or systemic disease.
- •Children with any physical disabilities.
- •Children allergic to local anaesthesia.
- •Children with history of any previous dental extraction.
结局指标
主要结局
Satisfactory effectiveness of music as an audio distraction therapy during simple extraction procedures in children.
时间窗: Preoperative, during local anaesthesia administration and during extraction procedure.
次要结局
- Better effectiveness of music with vocals than without vocals during simple extraction procedures in children.(Preoperative, during local anaesthesia administration and during extraction procedure.)
- Better effectiveness of music with headphones than speaker during simple extraction procedures in children.(Preoperative, during local anaesthesia administration and during extraction procedure.)
研究者
Akansha Gupta
Maulana Azad Institute of Dental Sciences