Evaluation of effectiveness of robot-based distraction in comparison with conventional methods on anxiety and pain perception during local anesthesia administration in pediatric patients: a randomized clinical trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction in dental anxiety experienced by the child during the administration of local anesthesia
研究概览
简要总结
The study design involves a two-armed, parallel-group, randomized controlled trial conducted at the Department of Pediatric & Preventive Dentistry, Sri Rajiv Gandhi College of Dental Sciences & Hospital, Bengaluru. Children in the age group of 4-7 years meeting the eligibility criteria will be recruited, and their parents will be provided with an information sheet with a detailed description of the study and requested to give informed consent for participation. The study aims to determine the effectiveness of robot-based distraction in comparison to conventional behaviour management methods in reducing dental anxiety of children during local anesthesia administration. The children will be randomly allocated into two groups: a Control Group receiving conventional behaviour management techniques during local anesthesia administration and an Intervention Group receiving the same standard care along with robot-based distraction. Anxiety will be assessed using the Raghavendra, Madhuri, Sujata Pictorial Scale (RMS-PS) and pulse rate measurements (Physiological measure). The Face, Legs, Activity, Cry, Consolability (FLACC) scale will be used to assess pain during anesthesia administration. Administration of inferior alveolar nerve block will be carried out in all children by a single clinician following a uniform administration protocol. All the observational and physiological measures of anxiety, and pain assessment will be recorded by another investigator not participating in the clinical procedure. Due to the nature of intervention, it will not be possible to blind the investigators, children or parents. The proposed research hypothesis is that the addition of robot-based distraction to conventional behaviour management methods during local anesthesia administration in children will decrease the anxiety and improve pain related behaviour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 4.00 Year(s) 至 7.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy children of both genders in the age group of 4 to 7 years with no known allergy and/or sensitivity to local anaesthesia.
- •Children with no previous experience of dental treatment.
- •Children requiring non-emergency dental treatment under local anesthesia (Inferior alveolar nerve block) Children of parents willing to give informed consent.
- •Children categorized under rating 2 or 3 on Frankl behaviour rating scale.
排除标准
- •Children with physical/mental/developmental disorders.
- •Children with complaints of severe pain requiring emergency treatment.
- •Children categorized under rating 1 or 4 on Frankl behaviour rating scale.
结局指标
主要结局
Reduction in dental anxiety experienced by the child during the administration of local anesthesia
时间窗: 10 minutes
次要结局
- Reduction in pain perception of the child during administration of local anesthesia(2 minutes)
研究者
Abhilasha
Sri Rajiv Gandhi College of Dental Sciences and Hospital Bangalore