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临床试验/CTRI/2024/04/065443
CTRI/2024/04/065443已完成Phase 3 4

EVALUATION OF EFFECTIVENESS OF HINDUSTANI CLASSICAL MUSIC AND TELL SHOW DO TECHNIQUE ON THE ANXIETY OF CHILDREN RECEIVING ORAL HEALTH CARE:A SINGLE BLINDED STUDY

Dr Niraj Gokhale1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月25日最近更新:

试验速览

阶段
Phase 3 4
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Pulse Rate

研究概览

简要总结

Music has shown to be a non pharmacological adjuvant to reduce stress and anxiety Indian classical music in particular has shown promising results in reducing the anxiety and stress during various procedures.

There are a number of ragas which exist, but on literature search it was seen that Raga Todi which is played in the morning time and Raga Bhimpalas played in the afternoon are particularly helpful in reducing anxiety. Hence these two ragas are selected for the study

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 12.00 Year(s)(—)
性别
All

入选标准

  • Children between the age group of 4-12 years.
  • Children reporting for dental treatment for first time.
  • Children requiring both non invasive (scaling and restorations) and invasive treatments (pulp therapy and extraction).

排除标准

  • Patients with painful dental experience in past Patients with special health care needs Children with hearing defects Patients who do not want to participate in the study.

结局指标

主要结局

Pulse Rate

时间窗: Before and at the end of the procedure

次要结局

  • Self administered anxiety using Venhams picture scale & Operator Assessed behaviour by Frankls behaviour rating scale(Before & After the completion of the treatment)

研究者

发起方
Dr Niraj Gokhale
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr. Niraj S. Gokhale

KAHERS KLE VK INSTITUTE OF DENTAL SCIENCES

研究点 (1)

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