A comparative evaluation of pain perception and anxiety levels in children during local anesthesia procedure using intraoral and extraoral vibratory systems and conventional local anesthesia with topical anesthestic gel.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To evaluate pain perception & anxiety levels during local anesthesia administration with conventional technique, intraoral technique and extraoral technique.
研究概览
简要总结
Pain is defined as an unpleasant sensory or emotional experience associated with actual or potential tissue damage or described in terms of such damage.
An important reason for avoidance of dental procedures in children is needle phobia, defined as an extreme fear and anxiety associated with needles. Children with needle phobia are at risk of presenting fear of healthcare professionals and experience higher levels of pain and fear during dental procedures.To alleviate the pain and fear associated with the needle prick several topical anesthetics like ointments, anesthetic sprays, gels, or adhesive patch are recommended.
Other methods like application of cold stimuli on the injection site before local anesthesia (LA) administration were also commonly used as an easy and physiologically effective procedure without any surplus costs.It has been advocated that the cold element might confuse the pain pathway’s reception of signals, allowing for a "masking effect of pain."
In addition to the above-mentioned methods other systems like vibrators are used to reduce the pain associated with local anesthetic injection.
The present study is to compare the efficacy of intraoral and extraoral vibratory systems and conventional local anesthesia with topical anesthetic gel to evaluate pain perception and anxiety levels in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor 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
- •Healthy children with no systemic illness Children experiencing chronic dental pain Patients requiring LA administration for dental treatment Children with informed parental consent.
排除标准
- •Children with known systemic disease Children without parental consent Children with acute dental pain.
结局指标
主要结局
To evaluate pain perception & anxiety levels during local anesthesia administration with conventional technique, intraoral technique and extraoral technique.
时间窗: baseline
次要结局
未报告次要终点