Impact of binaural audiovisual aid with and without immersive projection on behaviour assessment in children undergoing dental treatment - A Randomized Crossover Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary outcome of the study was the reduction in dental anxiety levels during treatment, assessed both physiologically and behaviorally.
研究概览
简要总结
This randomized controlled crossover trial aims to evaluate the impact of a binaural audiovisual aid with and without immersive projection on reducing dental anxiety in children undergoing dental treatment. Children often experience high levels of fear and anxiety in dental settings, which can interfere with treatment compliance and overall experience. Audiovisual distraction techniques, especially when combined with binaural sound and immersive projection, may provide a more engaging and effective method to alleviate anxiety compared to conventional methods. The study will randomly allocate participants into intervention and control groups to assess differences in dental anxiety levels during treatment. The findings are expected to inform safer, child-friendly approaches for anxiety management in pediatric dentistry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator 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 requiring dental restoration.
- •Moderate to high levels of baseline dental anxiety, as determined by the Modified Child Dental Anxiety Scale (MCDAS).
- •Ability to understand and comply with study procedures.
排除标准
- •Hearing impairments.
- •Neurological or psychological disorders.
- •Use of anxiety-reducing medication within 24 hours prior to the procedure.
结局指标
主要结局
The primary outcome of the study was the reduction in dental anxiety levels during treatment, assessed both physiologically and behaviorally.
时间窗: baseline | immediate post intervention
次要结局
- The secondary outcome was the level of cooperation during dental procedures, inferred from FLACC FIS scores(baseline)
研究者
Nilesh V Rathi
Dr. D. Y. Patil Dental College and Hospital