Comparative Evaluation of Virtual Cognitive Distraction and Brainwave Entrainment in Reducing Dental Anxiety in Children Aged 7–12 Years: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Mean change in Facial Image Scale (FIS) score from baseline (pre-procedure, immediately before local anesthesia) to during local anesthesia administration (at the time of injection), comparing Group A (Virtual Cognitive Distraction), Group B (Brainwave Entrainment) and Group C (Standard behaviour management).
研究概览
简要总结
Dental anxiety in children is a common barrier to providing optimal dental care, often resulting in behavioural management challenges and incomplete treatment. Non- pharmacological distraction techniques have been shown to reduce anxiety by diverting the child’s attention from the dental procedure. Among these, Virtual cognitive Distraction using immersive virtual reality ( VR) environments and brainwave entrainment using binural beats are emerging approaches that offer engaging and non-invasive alternatives to conventional methods. This RCT aims to compare the effectiveness of Virtual Cognitive Distraction and Brainwave Entrainment in reducing anxiety among children aged 7-12 years undergoing minimal invasive dental procedures. Fifty-six healthy children meeting the inclusion criteria will be randomly allocated into two groups - group-1 Virtual cognitive distraction and group-2 Brainwave entrainment via headphones.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 7.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy children aged between 7–12 years Cooperative behavior (Frankl rating scale 3 or 4) No history of traumatic dental experiences Child who is visiting the dental clinic for the first time.
排除标准
- •Children with neurological, psychological, or developmental disorders Children with visual or auditory impairments Children under medication that may affect mood, behavior, or anxiety levels.
结局指标
主要结局
Mean change in Facial Image Scale (FIS) score from baseline (pre-procedure, immediately before local anesthesia) to during local anesthesia administration (at the time of injection), comparing Group A (Virtual Cognitive Distraction), Group B (Brainwave Entrainment) and Group C (Standard behaviour management).
时间窗: at baseline single visit
次要结局
- Mean change in pulse rate (beats per minute) from baseline (pre-procedure) to during the procedure, measured using a pulse oximeter.(Mean change in systolic & diastolic blood pressure (mm Hg) from baseline to during the procedure, measured using an automated BP monitor appropriate for children.)
研究者
DrAsifa Gazali
Maratha Mandal N G H Institute of Dental Sciences , Belagavi