Virtual Reality in the Operating Room: Using Immersive Relaxation as an Adjunct to Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Intraoperative Propofol Dose
研究概览
简要总结
This is a randomized, controlled trial designed to investigate whether the use of virtual reality immersive relaxation during hand/arm operations can allow for a relaxing operating room experience for patients while potentially reducing anesthesia requirements.
详细描述
The proposed study is a randomized, controlled trial to evaluate the effectiveness of VR as an adjunct to standard anesthetic practice for upper extremity surgery. Patients will be randomized to undergo immersion relaxation via the use of VR during their procedure or control. In both groups patients will undergo regional anesthesia preoperatively according to standard practice. Patients will then be assessed postoperatively to assess the intraoperative propofol dose between groups, as well as secondary outcomes including patient satisfaction.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Patients undergoing upper extremity (hand, wrist, arm, and/or elbow) surgery at BIDMC under MAC
排除标准
- •Age < 18
- •Open wounds or active infection of the face or eye area
- •History of seizures or other symptom linked to an epileptic condition
- •Patients who plan to wear hearing aids during the procedure
- •Patients with a pacemaker or other implanted medical device
- •Droplet or airborne precautions (as determined by BIDMC infection control policy)
- •Non-English speaking
- •Patients who require deep sedation
- •Patients who are deemed ineligible to approach by the surgeon
研究组 & 干预措施
Usual Anesthesia Care
Patients in the usual care arm will undergo the current standard of care for hand/wrist surgery and postoperative recovery. They will be asked to refrain from using a virtual reality headset during their surgery.
Virtual Reality Immersive Relaxation
Patients in the experimental group will wear a headset and be immersed in a virtual reality environment during their surgery. There are various short videos and environments such as sitting on a beach that are designed to promote relaxation and calmness.
Throughout their surgery patients will be monitored according to current anesthesia standards. The relaxation programming will run for the duration of the operative procedure. At the end of the procedure the headset will be removed and standard postoperative care will commence.
干预措施: Virtual Reality Immersive Relaxation (Other)
结局指标
主要结局
Intraoperative Propofol Dose
时间窗: 60 minutes
Total propofol dose (mg/kg/min) administered intraoperatively will be measured for the duration of the procedure.
次要结局
- Other Intraoperative Anesthetics or Analgesics Administered(60 minutes)
- Total Intraoperative Propofol Administered(60 minutes)
- Length of PACU Stay(Duration of the patient's stay in the post anesthesia care unit, 100 minutes)
- Patient Survey: Agreement With the Following Statements (0-100)(PACU discharge)
- Difference Between Preoperative and Postoperative QuickDASH Scores(One month postoperatively)
- Pain Assessed by Eleven Point Numerical Rating Scale(Duration of stay in the post anesthesia care unit, 100 minutes)
- Overall Patient Satisfaction(PACU discharge)
- Hand Disability (QuickDASH)(One month postoperatively)
研究者
Brian O'Gara
Attending Anesthesiologist, Principal Investigator
Beth Israel Deaconess Medical Center