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临床试验/CTRI/2026/02/102674
CTRI/2026/02/102674尚未招募4 期

A Comparative Evaluation of Low-Frequency Weighted Noise, High-Frequency Weighted Noise, and Animated Audio Stimuli on Dental Anxiety in Pediatric Patients Aged 5–7 Years: A Randomized Controlled Trial

Manav Rachna Dental College1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2026年2月14日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
45
试验地点
1

研究概览

简要总结

This randomized controlled trial evaluates the effect of low frequency weighted noise high frequency weighted noise and animated audio stimuli on dental anxiety in children aged five to seven years undergoing restorative dental treatment. Pediatric dental anxiety often results in poor cooperation and difficulty in completing treatment. Audio distraction is a simple non pharmacological method used to reduce anxiety in children.

Forty five children will be randomly allocated into three groups of fifteen each. Group A will receive low frequency weighted noise Group B will receive high frequency weighted noise and Group C will receive animated audio stimuli through noise cancelling headphones during the dental procedure. Dental anxiety will be assessed using the FLACC scale and behavior will be evaluated using the Frankl behavior rating scale. The study aims to identify an effective audio distraction method for behavior management 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 and Investigator Blinded

入排标准

年龄范围
5.00 Year(s) 至 7.00 Year(s)(—)
性别
All

入选标准

  • Children aged 5–7 years, Frankl Behavior Rating Scale 3 (Positive) and 4 (Definitely Positive),Children requiring restorative dental treatment.Written informed consent obtained from parent/guardian.

排除标准

  • Children with systemic diseases, Children with special health care needs, Children whose parents/guardians do not provide consent.

研究者

申办方类型
Other [not applicable]
责任方
Principal Investigator
主要研究者

Dr Saumya Parashar

Manav Rachna Dental College and Hospital

研究点 (1)

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