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临床试验/NCT04234737
NCT04234737已完成不适用

Efficacy of Hypnotherapy in Children Aged 8-12 Years Old With Dental Anxiety: A Randomized Clinical Trial

Ataturk University2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2019年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Modified Children Dental Anxiety Scale Faces version MCDAS(f)

研究概览

简要总结

Dental anxiety is a common problem among the children. The aim of this study is to evaluate the efficacy of hypnotherapy in children with dental anxiety. The participants will be randomized in a 1:1 ratio to hypnotherapy or control group. The outcome measures will be Modified Children Dental Anxiety Scale-faces version(MCDAS(f)) and Visual Analogue Scale(VAS).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • initial MCDAS(f) total score > 19
  • ICDAS II (international caries detection and assessment score)= 5 for at least one tooth

排除标准

  • presence of dental pain complaint
  • non-obtaining the informed consent form

结局指标

主要结局

Modified Children Dental Anxiety Scale Faces version MCDAS(f)

时间窗: maximum 1 week after hypnotherapy.

Modified Children Dental Anxiety Scale is a self-reported measurement and consists of 8 questions with 5 pictorial answers for each question. Total score ranges from 8 to 40, with higher scores higher dental anxiety.

次要结局

  • Visual Analog Scale (VAS)(during dental treatment)

研究者

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

Elif Kardes

Principal Investigator

Ataturk University

研究点 (2)

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