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临床试验/CTRI/2024/01/061679
CTRI/2024/01/061679已完成2 期

A Comparative evaluation of the effect of white noise, brown noise and pink noise on dental anxiety of paediatric patients undergoing dental extraction treatment –A Randomised Control Study.

Dr Pooja K Dialani1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年1月25日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Reduction in dental anxiety after the treatment using different types of Audio distraction.

研究概览

简要总结

This research study focuses on addressing the challenges of managing anxiety in pediatric dental patients, emphasizing the preference for non-invasive psychotherapeutic techniques over pharmacological interventions. The study explores the application of audio analgesia, specifically white noise, brown noise, and pink noise, to distract pediatric patients during dental extraction treatments.

The introduction provides a comprehensive background on the management of anxious pediatric patients, highlighting the significance of non-pharmacological techniques in avoiding adverse effects and discomfort associated with drugs. Audio analgesia, introduced in 1959, is discussed as a technique that uses audio means to relieve pain during medical procedures.

The primary question revolves around the potential effects of different frequencies of noises on dental anxiety in pediatric patients aged 8 to 12 years. The primary hypothesis suggests that there is a difference in the effects of white noise, brown noise, and pink noise on dental anxiety during extraction treatment, while the secondary hypothesis questions the presence of such a difference.

The literature review cites a study by Divya Singh et al. (2022) that explored the effects of pink, brown, and white noise on anxious dental patients. The study concluded that audio distraction, regardless of the specific sound shade, was responsible for reducing anxiety.

The aim and objectives of the study are clearly defined, focusing on evaluating and comparing the effects of white, brown, and pink noise on dental anxiety in pediatric patients during extraction treatment. The primary objective includes the evaluation and comparison of the effects on dental anxiety and pain perception.

The methodology outlines a multi-arm, triple-blinded, parallel-group randomized controlled study design. The source of data is the Out Patient Department of the Department of Pediatric & Preventive Dentistry at JMF’s ACPM Dental College, Dhule. Inclusion and exclusion criteria are specified, and the sample size is determined based on a statistical model. The study groups, randomization process, and procedures are detailed, including the use of Venham’s picture scale, pulse rate measurement, and Visual Analogue scale.

The statistical analysis plan includes Mann-Whitney U tests and paired t-tests to compare age, anxiety scores, and post-operative anxiety levels between groups.

In summary, the study aims to contribute to the understanding of the impact of different frequencies of noises on dental anxiety in pediatric patients, utilizing a rigorous research design and comprehensive evaluation methods. The research findings have the potential to inform future non-pharmacological interventions in pediatric dentistry.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
8.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Children with Frankl Behavior rating scale of negative (-) and positive (+) Children having their primary tooth indicated for extraction Children who are willing to participate in the study.

排除标准

  • Children with special health care needs.
  • Children requiring restorative procedures.
  • Children with deep carious lesions who require pulp therapy.
  • Children who are not willing to participate in the study.

结局指标

主要结局

Reduction in dental anxiety after the treatment using different types of Audio distraction.

时间窗: After local anesthesia administration and after treatment.

次要结局

  • Comparing the differences in the reduction of dental anxiety and pain using White noise, Brown noise, and Pink noise during the extraction treatment.(Before treatment)

研究者

发起方
Dr Pooja K Dialani
申办方类型
Other [Self sponsored]
责任方
Principal Investigator
主要研究者

Dr Pooja K Dialani

JMFs ACPM Dental College Dhule 424001.

研究点 (1)

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