Comparative Evaluation of Active, Passive and Active- Passive Distraction Methods To Assess Pain Perception in Pediatric Patients Aged 4 to 8 Years During Administration Of Local Anaesthesia - A Randomised Double Blinded Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- To find a effective distraction technique for LA administration among VR glasses, softball compression or combination of both.The effectiveness will be measured using FLACC scale.The FLACC scale includes components of Face, Legs, Activity, Cry and Consolability. The primary outcome is to check if the given distraction tool is effectively distracting the child during LA administration which will be observed using the FLACC scale.
研究概览
简要总结
The aim of the study is to evaluate active, passive and active-passive distraction methods for assessment of pain perception in patients aged 4 to 8 years during administration of local anaesthesia. The objective is to determine the effect of ACTIVE DISTRACTION (SOFTBALL COMPRESSION AND RELAXATION) as a distraction method in assessing dental pain perception during administration of local anaesthesia, the effect of PASSIVE DISTRACTION (VIRTUAL REALITY EYEGLASSES) as a distraction method in assessing dental pain perception during administration of local anaesthesia, the effect of ACTIVE-PASSIVE DISTRACTION (SOFTBALL COMPRESSION AND RELAXATION ALONG WITH VIRTUAL REALITY EYEGLASSES) as distraction method in assessing dental pain perception during administration of local anaesthesia and to compare dental pain perception during administration of local anaesthesia using above three techniques. The children will be grouped in Group A, B and C according to the distraction method to be used. LA will be administered. A second operator of Department of Pediatric and Preventive Dentistry, Manav Rachna Dental College will assess the children’s pain reaction during the injection procedure using FLACC (Face, Legs, Activity, Cry and Consolability) BEHAVIOURAL ANXIETY/PAIN ASSESSMENT SCALE
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 4-8 years
- •Presence of teeth with pulp involvement in which need of pulpal therapy necessitates the administration of local anaesthesia.
- •Co-operative patients (Frankl’s Behaviour Rating Scale – Positive + and Definitely Positive ++).
排除标准
- •Children with sensory disabilities
- •Previous experience with intraoral injections.
- •Allergy to Lignocaine Hydrochloride
- •History of systemic illness.
结局指标
主要结局
To find a effective distraction technique for LA administration among VR glasses, softball compression or combination of both.The effectiveness will be measured using FLACC scale.The FLACC scale includes components of Face, Legs, Activity, Cry and Consolability. The primary outcome is to check if the given distraction tool is effectively distracting the child during LA administration which will be observed using the FLACC scale.
时间窗: Baseline
次要结局
- To compare between active distraction (softball compression), passive distraction (VR eye glasses) and active-passive distraction (VR eye glasses and softball compression) method for LA administration. The secondary outcome includes assessing which group out of the three were effectively distracted with the tool they were provided with.(Baseline)