The Effect of Using Camouflaged Dental Syringe on Children's Anxiety and Behavioral Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Anxiety
研究概览
简要总结
Seeing the dental syringe can be terrifying, especially for young children. Hiding the dental syringe during local anesthesia (LA) administration can sometimes be challenging for the pediatric dentist. Therefore, this randomized clinical trial aims to assess the effect of a camouflaged dental syringe on children's anxiety and behavioral pain in comparison to the traditional dental syringe during local anesthesia administration in pediatric patients. It will include cooperative and healthy 6-10-year-old children scheduled for non-urgent dental treatment that requires buccal infiltration anesthesia (BIA) in the maxillary arch. The subjects will be randomized into either the test or the control groups. In the test group, subjects will receive BIA using the camouflaged dental syringe. Subjects in the control group will receive the BIA using the traditional dental syringe. A single-trained dentist will administer all the anesthesia. Heart rate (HR) will be monitored at three different time points (before, during, and after) the BIA administration. Subjects' anxiety and behavioral pain will be measured through Venham's Anxiety Rating Scale (VARS) and the Face, Leg, Activity, Cry, and Consolability (FLACC) scale, respectively, by two trained and calibrated investigators.
详细描述
This randomized clinical trial will take place at the Pediatric Dentistry clinics at King Abdulaziz University Faculty of Dentistry (KAUFD). Ethical approval will be obtained from the Research Ethical Committee at King Abdulaziz University (053-02-19).
The dental files of all the children scheduled for non-urgent dental treatment at the Pediatric Dentistry Department clinics during the study period will be reviewed by a single trained general dentist to identify potentially eligible subjects.
Inclusion criteria will include healthy and cooperative 6-10-year-old children with no known allergy and/or sensitivity to local anesthesia and who are scheduled for non-urgent dental treatment that requires buccal infiltration anesthesia (BIA) of at least one maxillary molar.
The cooperation level of the children will be determined based on the child's behavior recorded in the dental file in their previous dental visits. Only children who will be reported to be positive or absolute positive according to Frankel's behavior rating scale will be considered eligible. Children who will be reported to be uncooperative during their previous dental visit or those who did not receive any previous dental treatment at KAUFD and, therefore, have no dental record will be excluded.
The same dentist will approach those who meet the inclusion criteria, and the research aim will be introduced to the legal guardians/parents. An Arabic consent and assent form will be signed by those who agreed to participate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Impossibility to blind the participant and operator to the intervention. The statistician was blinded to the groups.
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cooperative
- •6-10-year-old children
- •With no known allergy and/or sensitivity to local anesthesia and who are scheduled for non-urgent dental treatment that requires buccal infiltration anesthesia of at least one maxillary molar
排除标准
- •Children who were reported to be uncooperative during their previous dental visit
- •Children who did not receive any previous dental treatment at KAUFD and, therefore, have no dental record will be excluded.
结局指标
主要结局
Anxiety
时间窗: during the administration of the local anesthesia, the subjects will be recorded using a high-resolution camera. Later, two trained and calibrated investigators will watch the videos and evaluate the anxiety level of the subjects
Venham's Anxiety Rating Scale (VARS)
Behavioral pain
时间窗: during the administration of the local anesthesia, the subjects will be recorded using a high-resolution camera. Later, two trained and calibrated investigators will watch the videos and evaluate the anxiety level of the subjects
Face, Leg, Activity, Cry, and Consolability Scale (FLACC)
次要结局
未报告次要终点
研究者
Sara Mustafa Bagher
Associate Professor
King Abdulaziz University