The Use of Virtual Reality Goggles on Patient Pain and Behavior in Pediatric Dentistry; a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Self-reported patient perception of pain
研究概览
简要总结
The purpose of this research study is to evaluate the effectiveness of virtual-reality audio-visual distraction goggles on pain and behavior scores in a population of 8-12 year old dental patients receiving routine dental care in an outpatient clinical setting.
详细描述
All appointments will take place at the College of Dentistry Department of Pediatric Dentistry. The first day's appointment will consist of clinically-indicated cleaning, radiographs and treatment planning. Toward the end of the first appointment, the participant will wear the virtual reality goggles for 5 minutes, in order to become familiar with the device. During these 5 minutes, fluoride varnish will be applied. The application of the varnish would occur whether the participant is in the research or not.
At the second or third appointments, the goggles will be randomly used during the restorative treatment. Whether the participant uses the goggles at the second or third visit will be determined purely by chance, like flipping a coin. No nitrous oxide will be used, but local anesthesia will still be administered as standard. The participant will use a 1-10 scale at the end of each appointment to rate pain levels, and a research team member(the dental assistant) will assign a 1-4 scale value for behavior. The 1-10 scale will consist of the Wong-Baker Faces Pain Scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, no history of seizures or neurological disturbance, requires two quadrants of dentistry
排除标准
- •History of dental anxiety
研究组 & 干预措施
Control
Study group that does not wear the virtual reality goggles. This group will serve as a control.
干预措施: Virtual reality goggles (Device)
结局指标
主要结局
Self-reported patient perception of pain
时间窗: recorded immediately after each treatment session, during both the control visit and the experimental visit (patient acts as their own control)
The patient will complete a self-reported pain scale known as the Wong-Baker Faces Pain Scale. This is a 1-10 pain scale that has correlating faces. A 1 indicates no pain, and correlates with a happy face. A 10 correlates with a crying face and indicates severe pain. A single number between 1-10 is selected to indicate the patient's pain.
Behavior of child
时间窗: recorded immediately after each treatment session, during both the control visit and the experimental visit (patient acts as their own control)
Behavior in terms of child cooperation will reported by an unbiased dental assistant using the Frankyl behavior scale. Behavior means the child listens to instructions and follows directions given by the clinician. This is a 1-4 scale, with 1 indicating extremely uncooperative behavior (crying, strong movement) and 4 indicating positive, cooperative behavior.
次要结局
未报告次要终点
研究者
Casey Goetz
Pediatric Dentistry Resident
University of Iowa