"Evaluation of Virtual Reality Based Distraction on Anxiety and Pain Perception in Paediatric Dental Extraction: A Randomized Controlled Trial"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- Child Dental Anxiety (Self-Report)
研究概览
简要总结
The goal of this clinical trial is to learn if virtual reality distraction can reduce dental anxiety and pain perception in children aged 6-10 years undergoing simple dental extraction. The main questions it aims to answer are:
Does virtual reality distraction lower dental anxiety compared to audio-visual distraction and conventional tell-show-do techniques?
Does virtual reality distraction reduce pain perception during dental extraction?
Researchers will compare virtual reality distraction, audio-visual distraction (2D cartoons with headset), and conventional tell-show-do with verbal distraction to see which method is most effective in improving child cooperation and reducing anxiety and pain.
Participants will:
Wear VR glasses to watch immersive 3D cartoons, or
Watch 2D cartoons with headset, or
Receive the conventional tell-show-do technique with verbal distraction.
Outcome measures will include child dental anxiety (CFSS-DS, VCARS), pain perception (Wong-Baker FACES), physiological parameters (pulse rate, SpO₂), and behavioral cooperation (Frankl scale).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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 to 10 years
- •Classified as ASA class 1 or 2 (healthy or with mild systemic disease)
- •Those who demonstrated Frankl behavior rating 2 and 3 toward dental procedures
- •Children with NO previous exposure to invasive dental procedure
- •No prior experience using VR glasses
- •Requiring extraction of mandibular deciduous molar under local anesthesia
排除标准
- •ASA 3 and above
- •Those who demonstrated Frankl behavior rating 1 and 4 toward dental procedures
- •Special needs ( intellectual and developmental)
- •Children on psychotropic medication
- •Children wearing glasses
- •Presence of intra-oral swelling
结局指标
主要结局
Child Dental Anxiety (Self-Report)
时间窗: Time Points: Baseline (before starting the procedure) and post-operative assessments ( after finishing the extraction)
Change in child dental anxiety will be measured using the Children's Fear Survey Schedule - Dental Subscale (CFSS-DS, Arabic version). The CFSS-DS consists of 15 items, each scored from 1 (not afraid) to 5 (very afraid), yielding a total score range of 15 to 75. Higher scores indicate greater dental anxiety (worse outcome). The unit of measure is the CFSS-DS score.
Child Dental Anxiety (Observation-based Assessment)
时间窗: Time points: This scale will be measured at 4 time points during the procedure: T0(baseline)= 15 min before starting the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 mins after the extraction
Change in child dental anxiety will also be assessed using Venham's Clinical Anxiety Rating Scale (VCARS). This observational scale is scored from 0 (relaxed) to 5 (out of control), with a total score range of 0 to 5. Higher scores indicate greater observed anxiety (worse outcome).
3a: Physiological Monitoring - Pulse Rate
时间窗: Will be measured at 4 time points: T0 ( Baseline)= 15 minutes before the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 minutes after extraction
Pulse rate will be monitored using a pulse oximeter. The unit of measure is beats per minute (bpm). In children, the normal resting pulse rate varies by age: Preschool children (3-5 years): \~80-120 bpm School-aged children (6-12 years): \~70-118 bpm Adolescents (13-18 years): \~60-100 bpm Higher values during the dental procedure indicate greater physiological arousal (worse outcome).
3b: Physiological Monitoring - Oxygen Saturation (SpO₂)
时间窗: Will be measured at 4 time points: T0 ( Baseline)= 15 minutes before the procedure T1= Time of needle penetration T2= Time of extracting the tooth T3= 5 minutes after extraction
Oxygen saturation will be monitored using a pulse oximeter. The unit of measure is percentage (%). In healthy children, normal SpO₂ values are typically 95-100% at rest. Lower values indicate poorer physiological status (i.e., worse outcomes).
次要结局
- Pain Perception (Self-Report)(at the end of the procedure)
- Child Behavior (Observation)(Time Points: Baseline (before the dental extraction procedure) and follow-up assessment at 1 month post-procedure)