Effectiveness of Technology-based Distraction Techniques on Pain Perception of Children With Attention-deficit Hyperactivity Disorder During Different Dental Procedures: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Pain-related behavior
研究概览
简要总结
The present study aims to assess and compare the effectiveness of different technology-based distraction techniques on pain perception and dental anxiety in children with Attention Deficit/Hyperactivity Disorder during different dental procedures
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children diagnosed with ADHD according to the DSM-V criteria and diagnosis confirmed by a pediatric neurologist.
- •All children should be on stimulant medication.
- •No previous dental experience.
- •Written consent of the legal guardian.
排除标准
- •Children with physical disabilities or other psychiatric disorders.
- •Children with visual or hearing disabilities.
- •Patients requiring emergency treatment.
研究组 & 干预措施
Virtual reality glasses
干预措施: Virtual reality glasses (Behavioral)
White noise
干预措施: White noise (Behavioral)
Basic behavior management techniques
干预措施: Basic behavior management techniques (Behavioral)
结局指标
主要结局
Pain-related behavior
时间窗: The scores were assessed perioperative at 4 procedures: • During needle penetration. • During rubber dam clamp application. • During caries removal. • During placement of composite restoration.
Children's behavior using the revised Face, Leg, Activity, Cry, Consolability scale (r-FLACC). The r-FLACC scale has been identified as a recommended measurement tool for assessing pain in children aged 0 to 18 years, with a high level of intra- and inter-reliability. Each of the r-FLACC's categories is scored from 0 to 2, which results in a total score between 0 and 10: 0 'relaxed and comfortable'; 1-3 'mild discomfort'; 4-6 'moderate pain'; and 7-10 'severe pain or discomfort or both. The operator assigned a score to each child based on the child's behavior by analysis of the recorded videotape.
次要结局
- Pulse rate(The pulse rate was recorded at the baseline and perioperative during needle penetration, rubber dam clamp application, caries removal, placement of composite restoration, and postoperatively after composite finishing and occlusal adjustment.)
- Self reported pain(The scale was administered at the baseline (preoperative) and postoperatively at the end of the visit.)
研究者
Nahla Aly
Assistant Lecturer of Pediatric Dentistry
Alexandria University