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临床试验/CTRI/2025/09/095102
CTRI/2025/09/095102尚未招募不适用

A comparative evaluation of neuro-acoustic music interventions for alleviating pediatric dental anxiety in children aged 4-10 years: A Randomized Controlled Trial

DR ADHITHI PRAKASH1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
IS MUSICAL INTERVENTION EFFECTIVE FOR ALLEVIATION OF ANXIETY AFTER ADMINISTRATION OF LOCAL ANESTHETIC AGENT DURING DENTAL TREATMENT?

研究概览

简要总结

This study design outlines a clinical trial evaluating the impact of neuroacoustic music interventions on pediatric dental anxiety during inferior alveolar nerve block (IANB) administration. The process begins with baseline data collection, which includes assessing the child’s behavior and anxiety levels using the Facial Behavior Rating Scale (FBRS), the RMS Pictorial Scale (RMS-PS), and recording their pulse rate. Participants are then randomly allocated into one of five groups through the use of sealed envelopes to ensure unbiased group assignment. Following group allocation, a neuroacoustic intervention is performed in the experimental groups by playing specific sound frequencies—such as Solfeggio tones, binaural beats, or isochronic tones—through headphones for a duration of 10 minutes. After the audio intervention, the dental procedure involving the administration of the inferior alveolar nerve block is carried out. Post-procedure, the children’s anxiety and behavior are re-evaluated using the same FBRS and RMS-PS tools to determine any changes in response to the intervention. Finally, all data is tabulated and subjected to statistical analysis to assess the efficacy of the neuroacoustic approach in reducing anxiety and improving patient behavior during local anesthesia.

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 Outcome Assessor Blinded

入排标准

年龄范围
4.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • a) Children requiring inferior alveolar nerve block for therapy of mandibular posterior teeth b) Children from 4-10 years of age c) Children with negative behavior according to Frankl’s behavior rating scale.

排除标准

  • a) Presence of systemic disease b) Hearing disabilities c) Children with special healthcare needs d) Patients who primarily require treatment in maxillary arch.

结局指标

主要结局

IS MUSICAL INTERVENTION EFFECTIVE FOR ALLEVIATION OF ANXIETY AFTER ADMINISTRATION OF LOCAL ANESTHETIC AGENT DURING DENTAL TREATMENT?

时间窗: ANXIETY LEVELS AT ARRIVAL(BASELINE), ANXIETY AFTER MUSIC FOR 10 MINUTES AND ANXIETY AFTER LOCAL ANESTHETIC AGENT ADMINISTRATION AFTER 15 MINUTES

次要结局

  • IS THERE ALTERATIONS IN PULSE RATE AFTER MUSICAL INTERVENTION FOR ADMINISTRATION OF LOCAL ANESTHETIC AGENT RESULTING IN IMPROVED BEHAVIOR(PULSE RATE AT ARRIVAL(BASELINE), PULSE RATE AFTER MUSICAL INTERVENTION(10 MINUTES) AND AFTER LOCAL ANESTHETIC (AT 15 MINUTES))

研究者

发起方
DR ADHITHI PRAKASH
申办方类型
Other [self funded]
责任方
Principal Investigator
主要研究者

DR ADHITHI PRAKASH

MANAV RACHNA DENTAL COLLEGE(MRIIRS), FARIDABAD

研究点 (1)

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