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临床试验/CTRI/2025/03/081715
CTRI/2025/03/081715尚未招募不适用

Evaluation of Anxiety levels using Tell-Show-Do, Music of Choice and Folk Music Songs as Audio Distraction Behaviour Guidance Techniques in Children aged 6-12years undergoing Dental Treatment: A Randomized Clinical Trial

KAHERS KLE Institute of Dental Sciences1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2025年3月15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
138
试验地点
1
主要终点
Anxiety in children undergoing dental treatment

研究概览

简要总结

Music therapy as a audio-distraction technique is a behavior guidance method.Suitable music has been shown to influence human brain waves, leading to deep relaxation and alleviating pain and anxiety. The present study protocol is designed in concordance with a novel behavior management technique ‘music distraction’ or ‘audio distraction’. ‘Audio distraction’ is the non-aversive technique in which the patient hears to music throughout a stressful dental treatment procedure**.**The musical melodies system of India is deeply rooted in folk songs which influences the folk music through the ages by one generation to another .There are number of folk songs available but no scientific literature on folk songs which reduces the anxiety in children undergoing dental treatment. Aim of the study is to evaluate and compare the anxiety levels using Tell-Show-Do, Music of Choice and Folk Music songs as Audio Distraction Behavior Guidance Techniques in Children aged 6-12years undergoing Dental Treatment.

CLINICAL SIGNIFICANCE:

Audio distraction used in the study will be non-aversive behavior guidance technique to manage a child appropriately in dental clinic. Music distraction will be an effective means of stress reduction in anxious pediatric dental patients undergoing dental treatment. Folk music songs and music of choice will be an alternative music distraction techniques as a emerging trend.

EXPECTED OUTCOME: The audio distraction behavior guidance(non-pharmacological) technique using folk music songs could be used successfully  to alleviate anxiety in children undergoing dental treatment

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
6.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Children between the age group of 6-12 years Children reporting for dental treatment for first time.
  • Children requiring Scaling/Restoration/Fluoride application without local anaesthesia Children requiring Restorations of deep carious lesions/Pulp therapy/ Extractions under local anaesthesia.

排除标准

  • Children with special health care needs Children showing Frankl Behavior rating 1 (i.e. Definitely negative) Children with Auditory impairment.

结局指标

主要结局

Anxiety in children undergoing dental treatment

时间窗: Before and after dental treatment at first and second visit

次要结局

  • Frankle Behaviour Rating Scales(Before & after dental treatment at first & Second visit)

研究者

发起方
KAHERS KLE Institute of Dental Sciences
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Shweta Kajjari

KLE V. K. Institute of Dental Sciences, KLE Academy of Higher Education And Research

研究点 (1)

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