跳至主要内容
临床试验/NCT04636580
NCT04636580已完成不适用

The Effect of Parents' Presence and Their Anxieties on Children's Dental Anxiety During Dental Procedures: Controlled Clinical Trial

Uşak University2 个研究点 分布在 2 个国家目标入组 160 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
160
试验地点
2
主要终点
change in anxiety during the treatment according to the accompaniment of the anxious parent of the child

研究概览

简要总结

Background: To evaluate the effect of the anxiety of a parent accompanying a child on the child's anxiety during treatment.

Methods: Parents of 160 patients (4-8 years old) were divided into two groups anxious and non-anxious. Each groups had separated two randomized subgroups that with/without parents accompanied their children. At the first visit, participating children were examined while the behavior of the child during the examination was evaluated by a single pediatric dentist according to their heart rates measured by a portable pulse oximeter and the data were recorded (objective data).Forty-two children with a score of 1 and 4 on the Frankel Scale were excluded. After the parents were divided into two groups, anxious and non-anxious, the groups were equally divided randomly and the parents accompanied their children during the treatment.

Patients were recalled after one week for the treatment visit. Both groups were evaluated using the basic behavior technique. Compomer fillings were performed on children with infiltration anesthesia. The children's heart rates were measured by a portable pulse oximeter during treatment. Finally, the children were asked to express how they felt about the treatment by pointing out one of the faces on the Wong-Baker Faces Scale (subjective data). The children also rated the experience on the Frankel scale administered by the same operator.

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

入排标准

年龄范围
4 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • mentally and physically healthy children with caries requiring anesthesia and no previous dental experience were selected for the study

排除标准

  • children with a score of 1 and 4 on the Frankel Scale were excluded.

结局指标

主要结局

change in anxiety during the treatment according to the accompaniment of the anxious parent of the child

时间窗: An average of 6 months

The child's anxiety during examination was evaluated with a pulse oximeter. The child's anxiety during examination was evaluated with a pulse oximeter.

次要结局

未报告次要终点

研究者

发起方
Uşak University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tugba Yiğit

Principal Investigator

Uşak University

研究点 (2)

Loading locations...

相似试验

Parental Affect in Dental Procedures | 临床试验