COMPARATIVE ASSESSMENT OF PAIN PERCEPTION, ANXIETY, COMFORT AND EFFECTIVENESS BETWEEN NEEDLE AND NEEDLE LESS DEVICES DURING THE ADMINISTRATION OF PALATAL BLOCK FOR DIFFERENT DENTAL PROCEDURES IN CHILDREN AGED 4-9 YEARS.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
This parallel-group randomized controlled clinical trial will be conducted at SCB Dental College and Hospital, Cuttack, to compare and evaluate pain perception, anxiety level, comfort, and anesthetic effectiveness between needle-based (SlowJec CCLAD) and needle-free (INJEX 30) devices during the administration of palatal block for various dental procedures in children aged 4–9 years. Eligible children exhibiting Frankl behaviour ratings of 3 and 4 and with no prior history of palatal block will be randomly allocated into two groups. Pain perception will be assessed subjectively using the Wong–Baker Faces Pain Rating Scale, while anxiety will be evaluated using the Modified Child Dental Anxiety Scale (MCDAS). Objective parameters will include heart rate monitoring and behavioral responses assessed using the Sound-Eye-Motor (SEM) scale.
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
- 4.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •Children requiring palatal infiltration during dental procedures,Children belonging to the age group of 4-9 years,Children displaying Frankl behaviour ratings 3 and 4,Children who had never been administered a palatal infiltration.
排除标准
- •a.Children with learning and audio-visual impairment.
- •b.Children with any underlying systemic diseases.
- •c.Children with a pacemaker.
- •d.Children who are allergic to local anesthetic agents.
- •Children whose parents are not willing to participate in the study.
研究者
Shibani Tudu
SCB dental college and hospital,Cuttack