Effectiveness of Augmented Reality as a Distraction Technique for Reducing Pain and Anxiety in Pediatric Dental Extractions: A Parallel-Group, Double-Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain Score Using Wong-Baker FACES Scale
研究概览
简要总结
This randomized controlled trial evaluates the effectiveness of augmented reality (AR) as a distraction technique to reduce procedural pain and anxiety in children aged 6-10 undergoing primary tooth extraction. Participants will be randomly assigned to receive either AR distraction via VR goggles or standard tell-show-do behavior management during local anesthesia administration and extraction.
详细描述
Pain and anxiety are major challenges in pediatric dental care. AR presents an innovative, non-pharmacological technique to manage procedural distress. The study compares AR distraction versus conventional behavioral guidance in terms of self-reported pain (Wong-Baker FACES), dental anxiety (CFSS-DS), and physiological anxiety (heart rate monitoring). A double-blind design will ensure unbiased outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Both participants and outcome assessors/data analysts don't know group assignment.
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6-10 years
- •Indicated for anterior primary tooth extraction
- •No previous exposure to local anesthesia
排除标准
- •Medically compromised children
- •Children with cognitive or communication impairments
- •Children who underwent similar treatment within the past 3 months
研究组 & 干预措施
AR Distraction
Participants wear AR/VR goggles showing an interactive cartoon during LA injection and extraction.
干预措施: Augmented Reality Distraction (Behavioral)
Tell-Show-Do
Participants undergo standard Tell-Show-Do behavior guidance during treatment.
干预措施: Standard Care (Tell-Show-Do Technique) (Behavioral)
结局指标
主要结局
Pain Score Using Wong-Baker FACES Scale
时间窗: Immediately after the dental extraction procedure.
Pain was assessed immediately after local anesthesia injection using the Wong-Baker FACES Pain Rating Scale. This validated pediatric pain scale consists of six facial expressions ranging from 0 ("No pain") to 10 ("Worst pain"). Children were asked to select the face that best represented their pain experience, which was then converted into a numeric score. Values are reported as mean ± standard deviation (SD)and were compared between study arms.
次要结局
- 1. Children's Fear Survey Schedule-Dental Subscale(Immediately after the dental extraction procedure.)
- Heart Rate as Physiological Indicator of Anxiety(Immediately post-procedure)
研究者
ِAhmed kamel Abdel Naser soliman
Lecturer
Assiut University