跳至主要内容
临床试验/NCT04719299
NCT04719299已完成不适用

Effectiveness of Smartphone Application in Reducing Anxiety During Pediatric Dental Procedures: a Controlled Clinical Study

Hams Hamed Abdelrahman1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2020年4月20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
78
试验地点
1
主要终点
Change in dental anxiety scores

研究概览

简要总结

evaluating the effectiveness of smartphone applications (Tell-Play-Do) (TPD) in reduction of preoperative anxiety in children undergoing restorative treatment, as measured by heart rate and Venham's Picture Test.

详细描述

A total of at least 78 patients aged from 6-8 years will be included. All participants will be divided equally into two groups. Study group TPD using smartphone application and Control group (Tell-Show-Do) (TSD) using traditional behavior management technique.

Dental anxiety using Venham's Picture Test and heart rate using pulse oximeter will be assessed during dental treatment

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
6 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • School-age children aged from 6-8 years.
  • Presence of carious primary molars without pulpal involvement.
  • Parents have the ability to write, read and willingness to participate in the study.
  • First dental visit to the clinic.
  • Normal healthy children.

排除标准

  • Children with previous dental experience.
  • Medically compromised children.
  • Children with special needs (physical or mental).

结局指标

主要结局

Change in dental anxiety scores

时间窗: Baseline and immediate post operative

The number of times the "anxious" figure will be chosen a score of one will be assigned and then totaled to give a final score (minimum score - zero; maximum score - eight) for each patient. The final score will be interpreted as follow: 8 (Very high anxiety), Equal to or more than 6 and less than 8 (High anxiety), Equal to or more than 4 and less than 6 (Average), Equal to or more than 2 and less than 4 (Low anxiety), More than 0 and less than 2 (Very low anxiety) and 0 (No anxiety).

Change in heart rate

时间窗: Baseline and immediate post operative

recorded by using pulse oximeter as a potential secondary measure of anxiety (physiological parameter).

次要结局

未报告次要终点

研究者

发起方
Hams Hamed Abdelrahman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Alexandria University

研究点 (1)

Loading locations...

相似试验

Smartphone Application in Reducing Dental Anxiety | 临床试验