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临床试验/CTRI/2025/03/082183
CTRI/2025/03/082183招募中3 期

Comparative Assessment Of Anxiolytic Effect Of Homeopathy Medicine and Nitrous Oxide Oxygen Inhalation Sedation In Children

Dr Vaidehi Piyushbhai Patel1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年3月17日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
To evaluate Anxiolytic efficacy of aconitum napellus homeopathy medicine

研究概览

简要总结

Comparative assessment of anxiolytic effect of different agents in children during administration of local anesthesia

Abstract

Introduction:

Anxiety among paediatric patient is one of the most common problems encountered in the dental operatory which is also a challenge for the paediatric dentist. Among the various available antianxiety medicines in which homeopathy is a safe and natural alternative to conventional drug which is proved to be effective in both children and adult. Homeopathic medicines are used in paediatric dentistry to improve the psychological or emotional condition of patients without any side effects. Nitrous oxide (N2O) and oxygen (O2) have been recommended by the American Academy of Pediatric Dentistry as the optimal approach for uncooperative or anxious patients.

Aim:

The aim of the study is to compare anxiolytic efficacy of homeopathic medicine Aconitum Napellus CM and nitrous oxide inhalation sedation in children during dental procedures.

Objectives:

To check anxiolytic efficacy of homeopathy medicine Aconitum Napellus CM

Materials and methods:

3 to 8 years old children with no prior dental experience and requiring dental treatment are randomly divided into nitrous oxide inhalation sedation (group A) homeopathy medicine aconitum napellus CM (group B) and nitrous oxide inhalation sedation + homeopathy medicine aconitum napellus CM (group C) who were systemically healthy were included in the study.

Result:

Statistically analysed

Conclusion:

To be awaited

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
4.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Children aged between 4-8 years with no previous dental experience and whose behaviour fall into FRANKL negative (-) behaviour rating scale were included.

排除标准

  • Children with any medical history
  • Children with special health care needs
  • FRANKL definitely negative(--), definitely positive behaviour(++), positive(+)
  • Not ready to give written informed consent were excluded.

结局指标

主要结局

To evaluate Anxiolytic efficacy of aconitum napellus homeopathy medicine

时间窗: 6 months

次要结局

  • To compare anxiolytic effectiveness of aconitum napellus homeopathy medicine and nitrous oxide inhalation sedation(6 months)

研究者

发起方
Dr Vaidehi Piyushbhai Patel
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Vaidehi Patel

College of dental sciences and research centre

研究点 (1)

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