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临床试验/CTRI/2026/03/106316
CTRI/2026/03/106316尚未招募3 期

Augmenting virtual reality with binaural beats in reducing dental anxiety in children - A Randomized controlled trial

KSwapna Sundari1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年4月13日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1

研究概览

简要总结

Dental anxiety is a common problem among children and often interferes with the successful delivery of dental treatment. Various non-pharmacological behaviour management techniques have been introduced to reduce anxiety and improve cooperation. Virtual Reality (VR) is an emerging distraction technique that immerses children in an engaging virtual environment, thereby diverting their attention from the dental procedure. Binaural beats are a form of auditory stimulation believed to promote relaxation and reduce stress.

This randomized controlled trial aims to evaluate the effectiveness of combining binaural beats with Virtual Reality and Sensory Adapted Dental Environment (SADE) in reducing dental anxiety among children aged 6–12 years undergoing restorative dental treatment. A total of 60 children will be randomly allocated into four groups: conventional VR, VR with binaural beats, SADE alone, and SADE with binaural beats. Anxiety levels will be assessed using self-reported scales and physiological parameters such as heart rate and oxygen saturation.

The study aims to identify an effective non-pharmacological strategy for reducing dental anxiety and improving cooperation in pediatric dental patients.

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 requiring Class I restorative procedures.
  • Children who fall under categories II and III on Frankl’s behaviour rating scale.

排除标准

  • Children with systemic and intellectual disorders
  • Children who are claustrophobic
  • Children who require pharmacological behaviour management.

研究者

发起方
KSwapna Sundari
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

K Swapna Sundari

GITAM dental college and hospital

研究点 (1)

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