The Effect of Using a Sugar-free Candy Flavoring Before Local Anesthesia Injection on Anxiety and Pain Perception in Children: a Split-mouth Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
This is a randomized clinical trial that aimed to test the effect of using sugar-free flavors as a sensory distraction technique during local anesthesia on pain perception when compared to a negative control group. Applying the flavor before injecting local anesthesia helped in distracting the child and reduced the associated pain.
详细描述
Background: Distraction techniques can be very useful in managing children on the dental chair and to guide their attention away from a painful stimulus. No studies so far have used a sugar-free solution as a distraction method.
Aim: To test the effect of using sugar-free flavors as a sensory distraction technique during local anesthesia on pain perception and anxiety when compared to negative control group, using a split-mouth randomized study design.
Methods: A total of 84 children, aged 4-9 years with no previous dental experience and require the same treatment on the upper primary first or second molars bilaterally were included in this study. Each child received two injections. The children were randomly allocated into two groups, group 1 received the first injection after applying a flavor, and group 2 received the first injection after applying sterile water. The children received the first injection either on the right or left side, and switched sides on the next visit, resulting in (n=168) total injections. The observed pain perception was assessed using the SEM scale. Wong-Baker Faces pain rating scale will be used to assess the pain reported by the child. Pulse rate, BMI, and sweet taste preference were also recorded by an independent observer to ensure blinding.
Results: Using a sugar-free candy flavor before injecting local anesthesia helps in reducing pain accompanying local anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy (ASA Grade 1 status) children
- •First dental experience for the child including local anesthesia.
- •Children with caries lesions that require restorative treatment.
- •Children who require the same treatment on upper primary first or second molars bilaterally.
排除标准
- •Children with poor behavior (unable to cooperate for dental treatment).
- •Previous unpleasant dental experience (dental phobia).
- •History of abscess, redness, fistula in the injection site (need for extraction).
- •Presence of a systemic disease, mental, cognitive and intellectual disabilities.
研究组 & 干预措施
Study group
Will initially receive the infiltration injection after applying a candy flavor first, followed by sterile water in the next visit
干预措施: Local Anesthesia 1 (Procedure)
Study group
Will initially receive the infiltration injection after applying a candy flavor first, followed by sterile water in the next visit
干预措施: Local Anesthesia 2 (Procedure)
Control group
Will initially receive the infiltration injection after applying sterile water first, followed by candy flavor in the next visit
干预措施: Local Anesthesia 1 (Procedure)
Control group
Will initially receive the infiltration injection after applying sterile water first, followed by candy flavor in the next visit
干预措施: Local Anesthesia 2 (Procedure)
结局指标
主要结局
Pain score
时间窗: During injection
Reported pain by the child will be assessed using the Wong-Baker Faces Pain Rating Scale, Scores range from 0-10, higher scores mean more pain
次要结局
- Anxiety(Before and during injection)