Assessment of Dental Anxiety in children by using Multifaceted Distraction Technique during Local anaesthetic procedure- A Prospective Clinical Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Heart rate
研究概览
简要总结
**Background:**In Pediatric Dentistry, a child’s emotional state greatly affects pain perception, and local anesthesia can sometimes increase anxiety and pain. The emerging multifaceted distraction (MFD) technique aims to engage and soothe children during dental procedures. This study evaluates the efficacy of MFD in reducing pain and anxiety during inferior alveolar nerve blocks (IANB) in children aged 4-7 years and compared with Virtual Reality Distraction. Methods: Children aged 3-7 with dental anxiety will be randomly selected using the Modified Faces version of the MCDASf, with parental consent. They will be divided into two groups: Group A – Virtual Reality Distraction (VRD) and Group B – Multifaceted Distraction (MFD). Heart rate, SpO2, and salivary cortisol levels will be monitored before and after Local Anesthesia procedures. Pain and over all behavior assessment of each child will be assessed using Memoji’s Pain Scale and Houpt scale respectively after the procedure. The collected readings will be subjected to statistical analysis using the Student’s paired t-test for intragroup comparisons and non-parametric Mann-Whitney U test.
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
- 3.00 Year(s) 至 7.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children aged 3–7 years having their first dental visit. 2.A total score of revised Modified Children Dental Anxiety Scale.
- •Face Version (MCDASf) ≥19 indicating dental anxiety. 3.Children classified under ASA I group (American Society of Anesthesiologists physical status classification) and no history of allergy to local anesthetic solutions. 4.Requiring inferior alveolar nerve block for primary tooth treatment. 5.Tooth free from periodontal inflammation or infection to ensure effective local anesthesia.
排除标准
- •1.Children with neurobehavioral disorders.
- •3.Children with visual or auditory impairments.
- •4.Children sensitive to motion or flashing lights.
- •5.Children with injuries to the eyes, face, neck, or arms that hinder the effective use of a VR box.
结局指标
主要结局
Heart rate
时间窗: Baseline and also after completion of the dental treatment (post-operatively)
Partial pressure of oxygen
时间窗: Baseline and also after completion of the dental treatment (post-operatively)
Salivary Cortisol levels
时间窗: Baseline and also after completion of the dental treatment (post-operatively)
次要结局
- Memoji pain scale(“HOUPT†behavior rating scale)
研究者
Dr Janipalli Nikitha
GITAM dental college and hospitals