跳至主要内容
临床试验/CTRI/2026/02/103692
CTRI/2026/02/103692尚未招募不适用

Comparative Evaluation of Indian raga based procedural instructions in rhyming verse form and audio-visual aids on dental anxiety in children with autism spectrum disorder during administration of local anaesthesia: A randomized crossover trial

Dr Hitarth Vaishnav1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年2月23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
40
试验地点
1
主要终点
The customized raga-based audio intervention with rhythmic and rhyming procedural instructions results in a greater reduction in dental anxiety and improves behavioral cooperation among autistic children

研究概览

简要总结

Children with Autism Spectrum Disorder (ASD) often experience heightened dental anxiety, particularly during invasive procedures such as administration of local anaesthesia, due to sensory sensitivities and communication difficulties. Conventional audiovisual distraction techniques may not always be effective or well tolerated in this population. Music therapy, especially structured Indian raga-based music, has shown potential in modulating emotional and physiological responses and may serve as a sensory-adaptive, non-pharmacological intervention.

This randomized crossover clinical trial aims to compare the effectiveness of customized Indian raga-based audio incorporating rhythmic and rhyming procedural instructions with audio-visual distraction aids in reducing dental anxiety in children aged 6–12 years with ASD during administration of local anaesthesia. Each participant will undergo two intervention visits—one with audiovisual distraction and one with the raga-based audio intervention—separated by a washout period of at least one week.

Dental anxiety will be assessed using physiological parameters including electrodermal activity, heart rate, pulse rate, and oxygen saturation, along with behavioural assessment tools such as Venham’s Picture Test and Venham’s Clinical Anxiety Rating Scale. The study seeks to determine whether the raga-based auditory intervention provides superior anxiety reduction and improved cooperation compared to standard audiovisual distraction during dental procedures in children with ASD.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

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 aged 6–12 years with a confirmed diagnosis of ASD requiring dental treatment under local anesthesia.
  • Informed consent from parent or local guardian.

排除标准

  • patients with Profound hearing impairment or uncorrected auditory deficits, use of sedatives or anxiolytic medications.
  • Patients with diagnosis of Intellectual Disability or Down’s Syndrome or showing Severe uncooperative behavior unsuitable for non-pharmacological interventions.

结局指标

主要结局

The customized raga-based audio intervention with rhythmic and rhyming procedural instructions results in a greater reduction in dental anxiety and improves behavioral cooperation among autistic children

时间窗: Baseline and 1 month

次要结局

  • The customized raga based audio intervention with rhythmic & rhyming procedural instructions reduces electrodermal activity, heart rate, pulse rate & improves oxygen saturation(baseline)

研究者

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

Hitarth Vaishnav

Dr. D.Y. Patil Dental College and Hospital Pune

研究点 (1)

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