Investigating the Impact of Virtual Reality Glasses on Sedation Requirement and Patient Experience in Patients Undergoing Oral Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Level of anxiety
研究概览
简要总结
The goal of this randomized trial is to investigate if using virtual reality (VR) glasses for patients who require non-emergent oral surgery procedures under intravenous (IV) sedation improves their overall experience compared to using standard of care safety glasses.
This study has two primary objectives.
- To evaluate if VR glasses can improve patient tolerance during IV access, sedation induction, and the surgical procedure.
- To investigate whether the use of VR glasses reduces the amount of sedation required for induction and throughout the oral surgery procedure.
80 subjects will be randomly assigned 1:1 to either wear VR glasses playing a relaxing video and audio or VR glasses that will only serve as eye protection (control group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring IV sedation for oral surgery procedure
- •Patients able to understand the use of virtual reality glasses and provide informed consent/assent
- •Patients classified as American Society of Anesthesiologists (ASA) I or II
- •No reported substance use within the previous 24 hours
- •No reported excessive alcohol consumption
- •Willingness to wear eye protection
- •Willingness to use certified interpreters if required
- •A legal guardian must accompany minors
排除标准
- •Patient with hearing aids or severe hearing impairment
- •Patient with blindness or significant visual impairment that is not corrected by contact lenses
- •Patients with cognitive impairments determined and assessed by the researchers
- •Pregnant women or women who could be pregnant based on self reporting
- •Patients unable to tolerate virtual reality glasses due to motion sickness or other issues
- •Patients with history of seizures or epilepsy per self report
- •Patients who cannot tolerate VR glasses due to discomfort or a medical emergency that arises during the procedure
研究组 & 干预措施
Virtual Reality (VR) Intervention Group
Participants randomized to this group will receive VR glasses with a relaxation module (audio, visual) to wear during IV placement, induction of anesthesia, and during the procedure.
干预措施: Virtual reality (VR) glasses with relaxation module (Other)
Virtual Reality (VR) Control Group
Participants randomized to this group will receive VR glasses without a relaxation module to be worn only as safety glasses, during IV placement, induction of anesthesia, and during the procedure.
结局指标
主要结局
Level of anxiety
时间窗: 3 days before oral surgery, immediately before surgery, immediately after surgery, about 8 hours after surgery
Scores from the General Anxiety Disorder-7 (GAD-7) will be used to assess the level of anxiety. It is a 7-item instrument with each item scored from 0=Not at all to 3=Nearly every day. GAD-7 total scores for the can range from 0 to 21 with higher scores suggesting more anxiety. The scores are interpreted as 0-4: minimal anxiety, 5-9: mild anxiety, 10-14: moderate anxiety, and 15-21: severe anxiety.
Level of depression
时间窗: 3 days before oral surgery, immediately before surgery, immediately after surgery, about 8 hours after surgery
Scores from the Patient Health Questionnaire (PHQ-9) will be used to assess the level of depression. It is a 9-item depression screening tool with each item scored from 0=Not at all to 3=Nearly every day. Scores can range from 0 to 27, with higher scores suggesting more depression. The scores are interpreted as 0-4: None or minimal depression, 5-9: Mild depression, 10-14: Moderate depression, 15-19: Moderately severe depression, and 20-27: Severe depression.
Amount of Midazolam used
时间窗: pre-incision, 30 minutes post incision, 60 minutes post incision
The amount of this drug used will be abstracted form the medical record of each participant.
Amount of Fentanyl used
时间窗: pre-incision, 30 minutes post incision, 60 minutes post incision
The amount of this drug used will be abstracted form the medical record of each participant.
Amount of Propofol used
时间窗: pre-incision, 30 minutes post incision, 60 minutes post incision
The amount of this drug used will be abstracted form the medical record of each participant.
Amount of Ketamine used
时间窗: pre-incision, 30 minutes post incision, 60 minutes post incision
The amount of this drug used will be abstracted form the medical record of each participant.
次要结局
未报告次要终点