Active/Passive Parental Presence Influences Behavior of Preschoolers With Different Intelligence and Fear Levels in the Dental Setting: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Overall Behavior
研究概览
简要总结
Purpose: This study aimed to assess the effect of parental active/passive presence technique (PAP/PPP) on the overall behavior of preschool children with different intelligence and fear levels.
Methods: This randomized controlled trial recruited 150 healthy children, 3-6 years old, with no history of previous dental pain/treatment, IQ level ≤70 to ≤110. After sample collection, in the first visit, children were stratified according to their Intelligence Quotient into 3 equal groups (high, average, low) in which each group was further equally and randomly divided into 2 sub-groups (test and control). In the second visit, before intervention with preventive measures, dental fear was assessed using facial image scale. During intervention, the control sub-groups were managed using PPP technique, while the test sub-groups were managed using PAP technique. Overall behavior was assessed using Frankl behavior rating scale at the end of the 2nd visit. Data was analyzed using chi-square test and logistic regression analysis.
Results: The PAP technique had significantly higher odds of positive behavior than the PPP technique (P=0.002).
Conclusions: Children with low intelligence showed higher dental fear and negative behavior in the dental setting. PAP technique had significant positive effect on the children's overall behavior with different fear and intelligence levels.
详细描述
The design of the study was a randomized controlled clinical trial with an allocation ratio of 1:1. Children enrolled in this study were stratified based on their IQ into three groups; high, average and low IQ groups. In each of these three groups, children were randomly and equally allocated into study and control subgroups. Thus, this study included 6 subgroups.
- Visual Screening and History taking were carried out to identify children who fulfilled the inclusion criteria. Parental meeting was also conducted to explain the child entire research plan.
The children were recruited from the Outpatient clinic of Pediatric Dentistry Department in Faculty of Dentistry at Alexandria University.
The IQ test for each selected child took place in a quiet closed room (special need clinic). The preventive measures were applied in the pediatric clinic of the department.
- Interventions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Only biostatistician was blinded
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ranging from 3-6 years (the preoperational stage) (Piaget, 1954; 1966).
- •Patients with no history of previous dental treatment and no history of dental pain.
- •Patients with at least one sound quadrant for sealant application.
- •Patients IQ level should be in the normal intelligence range.
排除标准
- •Multiple dental problems with pain.
- •History of previous dental therapy
- •History of medical and psychological problems
- •Any degree of intellectual disability
结局指标
主要结局
Overall Behavior
时间窗: 1 month
Frankl's Behavior Rating Scale (FBRS) (Frankl, Shiere and Fogels, 1962) At the end of the second visit, after the application of preventive measures, each child overall behavior in each group was evaluated according to Frankl's Behavior Rating Scale (FBRS). It is a four group scale used to assess and evaluate the behavior of a child starting from Rating no. 1 (- -) with the most negative child behavior to Rating no. 4 (++) with the most positive child behavior.
Fear Measure
时间窗: 1 month
Facial Image Scale (FIS) (Buchanan and Niven, 2002) to account for fear state and is entered into the analysis as a confounder. Dental fear was measured in the second visit by administration of Facial Image Scale (FIS). This measurement was done to every child in each group before the start of dental treatment. It is comprised of a row of five faces ranging from very happy face to very unhappy one. Children were asked to point at which face they feel most like at that moment. The face is scored by giving a value of one to the most positive affect face and five to the most negative affect face. The faces with 1 and 2 indicated a low dental fear , while the faces with the value of 4 and 5 indicated high dental fear
次要结局
未报告次要终点
研究者
Dina Youssef Attia
Assistant lecturer
Alexandria University