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临床试验/NCT05371561
NCT05371561已完成不适用

Influence of Different Personal Protective Equipment on Children's Fear in Dental Office: A Randomized Controlled Trial

Fayoum University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2022年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
Arabic version of children's fear survey schedule-dental subscale (CFSS-DS)

研究概览

简要总结

the aim of the current study is to compare the effect of conventional facial PPE as 1)goggles + surgical masks, and 2)face shields + surgical masks versus 3)half-face and 4)full-face reusable respirators; on preoperative child's fear in the dental office.

详细描述

Each patient meeting the inclusion criteria and assigned to a specific study group will enter the clinic for dental examination. The examining dentist, wearing the selected PPE will communicate with patient and parent, taking personal, previous and current history, and carrying out simple examination not involving the use of sharp instruments, provoking pain or investigations as radiographs. The process should take from three to five minutes. Then, the child will be escorted to another room to meet a blinded accessor, where he assesses the child's anxiety using the Arabic version of children's fear survey schedule-dental subscale CFSS-DS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

Participants, legal guardians, and the dentist who carried out the examination were not blinded as it was inapplicable. The accessor and statistician were blinded

入排标准

年龄范围
6 Years 至 10 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Six to ten-year-old patients

排除标准

  • •emergency patients
  • •patients who have systemic, mental or psychological conditions as indicated by their medical history,

研究组 & 干预措施

Goggles + surgical mask

Active Comparator

Dentist wearing Goggles + surgical mask will examin the patient

干预措施: reusable respirators (Device)

Face shield+ surgical mask

Active Comparator

Dentist wearing Face shield+ surgical mask will examin the patient

干预措施: reusable respirators (Device)

Half face reusable respirator+ Filter

Experimental

Dentist wearing Half face reusable respirator+ Filter will examin the patient

干预措施: reusable respirators (Device)

Full face reusable respirator+ Filter

Experimental

Dentist wearing Full face reusable respirator+ Filter will examin the patient

干预措施: reusable respirators (Device)

结局指标

主要结局

Arabic version of children's fear survey schedule-dental subscale (CFSS-DS)

时间窗: just after examination

Children's fear survey schedule-dental subscale CFSS-DS is a tool to measure children's anxiety in dental settings. The CFSS-DS consists of 15 items, revolving around dental setting and procedures, child will answer each item by choosing a rate from a 5-point Likert scale that ranges from 1 ('not afraid at all') to 5 ('very afraid'), the total score should range from 15 to 75

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maha Moussa Azab

Lecturer

Fayoum University

研究点 (1)

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