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临床试验/NCT01658059
NCT01658059已完成不适用

Reducing Children's Anxiety Using Homeopathic Remedy Before Dental Treatment

Hadassah Medical Organization2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2012年9月最近更新:
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
22
试验地点
2
主要终点
Reducing Children's Anxiety

研究概览

简要总结

Pharmacological interventions to aid behavior management's techniques are commonly used in pediatric dentistry. The aim of the medicaments is to control behavior and allow safe completion of a dental procedure. Homeopathic remedy is safe and can be effective to control behavior and decrease anxiety in children during dental treatment.

Aim: 1. To explore the efficacy of homeopathic drugs in decreasing children's dental anxiety before dental treatment.

  1. To assess the effectiveness of homeopathic remedy in facilitating dental treatment for anxious children.

Methods: prospective, double-blind study. Thirty healthy children (5-12 years-old) will receive homeopathic remedy\placebo before dental treatment. Anxiety reduction will be measured using: saliva cortisol levels, saliva α-amylase levels, facial image scale (FIS), and Houpt behavior scale.

Expected results: the homeopathic remedy will reduce anxiety and increase child cooperation during dental treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • Dental anxiety
  • Needs at least 2 dental treatment appointments

排除标准

  • Medically compromised
  • Cooperative, needs less than 2 dental treatment appointments

研究组 & 干预措施

group 1

Experimental

homeopathic remedy first , placebo second

干预措施: Homeopathic remedy (Other)

group 1

Experimental

homeopathic remedy first , placebo second

干预措施: Placebo (Other)

group 2

Experimental

placebo first, homeopathic remedy second

干预措施: Homeopathic remedy (Other)

group 2

Experimental

placebo first, homeopathic remedy second

干预措施: Placebo (Other)

结局指标

主要结局

Reducing Children's Anxiety

时间窗: Each dental apointment, aproximatly 30 minutes on the average

Measuring levels of salivary cortisol and salivary α-amylase levels before dental treatment and after dental treatment .

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

Moti Moskovitz

clinical senior lecturer, department of pediatric dentistry

Hadassah Medical Organization

研究点 (2)

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