Comparison of Computer Controlled Automatic Injection Versus Conventional Injection Regarding Pain ,Anxiety and Child Behavior: "A Randomized Controlled 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
- Sound, eye, motor scale
研究概览
简要总结
This randomized controlled trial aims to compare the effectiveness of Computer-Controlled automatic injection device versus conventional injection techniques in pediatric dental patients. The study evaluates differences in pain perception, Anxiety levels ,and behavioral responses during dental procedures among children. by using validated pain and behavior assessment scales, this trial seeks to determine whether the use of automated injection system can improve the overall dental experience for children
详细描述
This randomized controlled trial aims to compare the effectiveness of Computer-Controlled automatic injection device versus conventional injection techniques in pediatric dental patients. The study focuses on evaluating and analyzing primary outcome ( pain perception) and secondary outcome ( anxiety levels )
Eligible participants will be healthy children who require dental treatment under local anesthesia. Participants will be randomly assigned to one of two Groups :
Groups A: Will receive The Star pen® system , incorporating battery-powered feedback for controlled pressure.
Group B: will receive conventional anesthetic syringe . pain will be assessed both subjectively using age- appropriate pain rating scales (such as Simplified Faces Pain Scale (S-FPS), and objectively using Sound, Eye, Motor scale .
Anxiety will be evaluated by measuring heart rate (objectively ). Child behavior during the procedure will be monitored and rated using venham's behavior scale.
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)
入排标准
- 年龄范围
- 6 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients aged 6-9 years.
- •Participants are required to undergo dental procedures requiring local infiltration anesthesia.
- •Only cooperative patients (scoring 3 or 4 on the Frankl Behavior Scale).
- •No prior dental experiences.
- •Patients need maxillary infiltration anesthesia.
- •No prior symptoms of abscess.
- •Only children with ASA I health status (Free from developmental or systemic disorders).
- •Parental consent and child assent required for enrollment.
排除标准
- •Medical conditions or systemic illnesses.
- •Psychiatric conditions affecting pain or anxiety evaluation.
- •Parental refusal or child unwillingness to participate
研究组 & 干预措施
computer controlled automatic injection ( Star pen® system)
Children will receive local anesthesia using a computer-controlled delivery system (Star Pen® device).
干预措施: computer controlled automatic injection (Star pen® system) (Procedure)
conventional anesthetic syringe
Children will receive local anesthesia using a conventional dental syringe.
干预措施: conventional anesthetic syringe (Procedure)
结局指标
主要结局
Sound, eye, motor scale
时间窗: Starting From point entry of anesthesia till end of injection procedure
Simplified Faces Pain Scale
时间窗: Immediately after injection procedure
次要结局
- Venham Behavior Rating Scale(Starting From point of entry of anesthesia till end of injection procedure)
- pulse oximeter(From sitting of patient on dental chair till the end of the injection procedure)
研究者
Nouran Negm ElDin Mahmoud
Master student
Future University in Egypt