Effect of mother tongue based immersive virtual reality distraction on anxiety and pain in pediatric dental patients during pulpectomy: A randomized control trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Reduction in anxiety and pain levels in pediatric dental patients undergoing pulpectomy using mother tongue-based immersive virtual reality distraction
研究概览
简要总结
This randomized controlled trial aims to evaluate the effectiveness of mother tongue-based immersive virtual reality (VR) distraction in reducing anxiety and pain in pediatric dental patients undergoing pulpectomy. The study compares two groups: one receiving VR content in their native language (mother tongue) and the other receiving the same content in English. Anxiety and pain levels will be assessed using behavioral scales (Facial Anxiety Scale, Modified Behavioral Pain Scale) and physiological parameters (heart rate, respiratory rate, and oxygen saturation).
Primary Purpose: To Assess the effectiveness of using immersive virtual reality in the child’s mother tongue to reduce anxiety and pain
Study Hypothesis: The mother tongue-based immersive virtual reality has an effect in reducing anxiety and pain levels, in pediatric dental patients during pulpectomy
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •6 to 8 year old children with irreversible pulpitis indicated for Pulpectomy in primary lower molars.
- •Frankles behavioral rating scale 3 and 4.
排除标准
- •Hearing and visual impairment.
- •History of epileptic seizure.
- •Children consuming anxiolytics.
- •Claustrophobic Children.
- •Motion sickness.
- •Mentally challenged.
- •Patient who requires any emergency dental treatment.
结局指标
主要结局
Reduction in anxiety and pain levels in pediatric dental patients undergoing pulpectomy using mother tongue-based immersive virtual reality distraction
时间窗: Before the procedure, | During administration of LA, | At the start of procedure, | 10 minutes after start of procedure, | After the procedure
次要结局
未报告次要终点
研究者
Anupama R
Kannur Dental College