Randomized Clinical Trial to Test a Preparation Protocol for the First Pediatric Dental Visit.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- child's behavior assessed by dentist with the Frankl Behavior Rating Scale (FBRS)
研究概览
简要总结
To date, not enough attention has been paid to the role of communication before the first dental visit to encourage the child's cooperation and avoid dysfunctional behaviors. The dentist can provide parents with the information they need to adequately prepare the child for treatment. The present study aims to investigate the effectiveness of an infor-mation booklet to promote pediatric patients' cooperation during the first dental visit
详细描述
The aim of the study was to test an Information Booklet preparing the child to the first dental vis-it. Forty-five children and one parent per included child took part in the trial. Children were ran-domized in two groups: the Information Booklet was e-mailed to the parents of the study group. At the end of the visit, the dentist and the parent evaluated the child's behavior through the Frankl Behavior Rating Scale (FBRS) and the utility of the Booklet through a Likert scale. The children evaluated the pleasantness of the visit and the perceived pain through the Wong-Baker FACES® Pain Rating Scale (WBFPRS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •child requiring a first dental visit
排除标准
- •previous dental visits, intellectual disability, mother tongue other than Italian, una-vailable e-mail address
研究组 & 干预措施
study group
Information Booklet prior to the dental visit
干预措施: Information Booklet (Behavioral)
control group
no information prior to the dental visit
结局指标
主要结局
child's behavior assessed by dentist with the Frankl Behavior Rating Scale (FBRS)
时间窗: immediately after the intervention
FBRS: values from 1 (Definitely negative) to 4 (definitely positive)
次要结局
- self reported pain assessed by the Wong Baker faces pain rating scale (WBFPRS)(immediately after the intervention)
研究者
Simone Bagattoni
Principal investigator
University of Bologna