Comparative Evaluation of The Analgesic Effect of Virtual Reality With Topical Anesthesia to Reduce Pain During Administration of Local Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Heart rate
研究概览
简要总结
A split-mouth, controlled trial aimed to clinically compare and evaluate the effectiveness of virtual reality versus topical anesthesia gel prior to administration of dental anesthesia injection in reducing the perceived pain and anxiety level in adult patients and to find out their preferred procedure.
Heart rate before and after the end of the procedure will be identified, pain intensity of the injection will be identified using a scale, and finally patients' preference will be identified using a questionnaire.
详细描述
Steps of the Experiment
Step I: before the administration of the local anesthesia injection, heart rate will be measured for the patients using an FDA Approved pulse oximeter (Santa Medical SM-165 Finger Pulse Oximeter). Findings will be recorded.
Step II: at the first appointment, patients will be randomly allocated to receive the injection of the local anesthesia either with topical anesthetic gel or with virtual reality in one side of the jaw.
Step III: immediately after dental anesthesia injection procedure, the patient will be asked to rate the level of perceived pain, using Wong-Baker faces pain rating scale (WBFPS).
Step IV: after the administration of the local anesthesia injection, heart rate will be measured for the patients an FDA Approved pulse oximeter (Santa Medical SM-165 Finger Pulse Oximeter). Findings will be recorded.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists (ASA) class I, aged between 18 and 65, both male and female, who required bilateral local anesthetic injections in the premolar teeth in the upper jaw.
- •Participants are in good general health, take no medications, and have no contraindications to the use of local anesthetic.
- •The ability to understand oral and written instructions, and the ability to use the VR controller.
排除标准
- •Patients who need intravenous sedation cannot participate in the study.
- •If a patient requires only single visit/ treatment or if he/she cannot attend the other visit.
研究组 & 干预措施
Virtual reality
Participants will wear a virtual reality headset during the dental injection in which a video is playing.
干预措施: Dental injection and virtual reality device (Device)
Topical gel
Participants will receive application of topical anesthetic gel on the site of dental injection.
干预措施: Dental injection and topical gel application (Drug)
结局指标
主要结局
Heart rate
时间窗: immediately after the intervention/procedure (injection)
heart rate will be measured for the participants using an FDA Approved pulse oximeter (Santa Medical SM-165 Finger Pulse Oximeter)
Wong-Baker faces pain rating scale (WBFPS)
时间窗: 3 minutes after the intervention/procedure (injection)
A tool to measure the intensity of pain comprising a scale from 0 to 10. The patient will select a number based on the intensity of the pain, "0" means no pain, "10" means extremely severe pain.
Participant's future preference
时间窗: 5 minutes after the intervention/procedure (injection)
Each participant will be asked by a questionnaire to state his/her preference for the delivery system of future injections
次要结局
未报告次要终点