Assessment of Different Coloured Noises as Non-Pharmacological Distraction Tools in Alleviating Anxiety and Pain during Local Anesthesia in Children: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- The primary outcome of the study is the reduction in pain and anxiety levels during local anesthesia administration in children, assessed using the Animated Emoji Scale (before and after the procedure), the Sound-Eye-Motor (SEM) Scale (during the procedure), and the Oucher’s Pain Scale (after the procedure).
研究概览
简要总结
This study will evaluate the effectiveness of auditory distraction using white noise pink noise and brown noise in reducing pain and anxiety during local anesthesia administration in children aged 6 to 11 years. A total of 66 healthy children will be randomly divided into three groups with 22 in each group. Three groups will receive different types of colored noise through headphones . Anxiety will be assessed using the Animated Emoji Scale before and after the procedure. Objective pain will be recorded using the Sound Eye Motor Scale during the procedure and subjective pain will be assessed using the Ouchers Pain Scale after the procedure. Physiological parameters such as pulse rate will be recorded before during and after local anesthesia. Data will be analyzed to compare the effectiveness of different colored noises in reducing pain and anxiety.
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 11.00 Year(s)（—）
- 性别
- All
入选标准
- •6-11 years old children Children who are willing to participate in the study.
- •Children requiring LA for dental procedures Children with no cognitive disorders Children whose parents/guardians provide written informed consent and who provide child assent.
排除标准
- •Children with hearing impairments or auditory processing disorders Those who are not willing to hear noises Special health care need Children Recent trauma to oral tissues Children with systemic illnesses or conditions contraindicating dental treatment.
- •Children with a history of hypersensitivity reactions to anaesthetic agent.
结局指标
主要结局
The primary outcome of the study is the reduction in pain and anxiety levels during local anesthesia administration in children, assessed using the Animated Emoji Scale (before and after the procedure), the Sound-Eye-Motor (SEM) Scale (during the procedure), and the Oucher’s Pain Scale (after the procedure).
时间窗: Assessments will be carried out at Baseline (before LA administration) | Immediate (during LA administration) | Immediate post-intervention (after LA administration)
次要结局
未报告次要终点
研究者
Ganganapalli Reddy Sravya
Narayana Dental College and Hospital, Nellore