Intraoperative Virtual Reality for Older Patients Undergoing Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Intraoperative Propofol Dose
研究概览
简要总结
The objective of this study is to investigate whether the use of virtual reality (VR) during total knee arthroplasty (TKA) can facilitate reductions in intraoperative sedative requirements while maintaining high levels of patient satisfaction as compared to both a music and sham VR + usual care control.
详细描述
The investigators will conduct a three-armed randomized controlled trial with the following aims:
Specific Aim 1: Evaluate whether the use of VR during TKA can facilitate a reduction in intraoperative propofol dose required for patient comfort as compared to music and sham VR + usual care controls.
Hypotheses: Patients in both the VR and music groups will demonstrate reductions in propofol dose compared to sham VR + usual care controls. A reduction in propofol dose between the VR and music group will be smaller in magnitude.
Specific Aim 2: Assess the effect of VR during TKA on patient reported outcomes including overall satisfaction, pain, and anxiety as compared to music and sham VR + usual care controls.
Hypotheses: Patients in the VR group will report significantly higher satisfaction and better control of pain and anxiety than those in the music group and usual care group.
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)
盲法说明
Assessors of the Confusion Assessment Method (CAM) and Montreal Cognitive Assessment (MoCA) will be blinded to group assignment.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 60 or older undergoing primary total knee replacement surgery at BIDMC and receiving spinal/regional anesthesia
- •English or Spanish speaking patients
排除标准
- •Complex or revision surgeries
- •Patients scheduled for "same day" TKA
- •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 local infection control policy)
- •Non-English speaking or Non-Spanish speaking
- •Moderate to severe dementia
- •Drop-Out Criteria:
- •MoCA <10 (this test will be administered on Day of Enrollment)
研究组 & 干预措施
Immersive VR group
Patients in the Immersive VR group will don a VR headset connected to a software platform on a tablet, as well as noise cancelling headphones. Patients can choose their desired experience within the VR software from a selection of immersive environments and/or video content. Examples include sitting in a canoe on a river, on a peaceful meadow or in a forest. Patients also have the option to listen to guided meditation or select from a library of videos to watch on a web-based user interface.
To reduce the influence of the anesthesia provider on the determination of sedative requirements, patients will administer their own sedation according to their needs for relaxation and comfort using a patient controlled system.
干预措施: Virtual Reality Immersive Relaxation (Other)
Music group
Patients randomized to the Music group will be equipped with VR headsets but won't view any content. They will also be equipped with noise cancelling headphones in the same fashion as the immersive VR group. A study team member will play from a library of music or other audible content (audiobook, podcast) that was preselected by the patient. Patients in the Sham VR group will also use patient controlled sedation.
干预措施: Immersive Audio Experience (Other)
Sham VR + Usual Care Control Group
Subjects in the control group will wear VR headsets and headphones but will not view any content or listen to any audible content. They will undergo Monitored Anesthesia Care (MAC) according to a prespecified protocol targeting light or moderate sedation with a propofol infusion.
干预措施: Sham Virtual Reality Experience (Other)
结局指标
主要结局
Intraoperative Propofol Dose
时间窗: Duration of the procedure, on average 1 to 3 hours
Total propofol dose (mg/kg/min) administered intraoperatively
次要结局
- Intraoperative Anesthesia Maneuvers(Duration of the procedure, on average 1 to 3 hours)
- Postoperative Pain(Measured on postoperative day zero and one, starting with PACU scores)
- Satisfaction with Anesthesia(Within an hour of admission to the postoperative anesthesia care unit)
- Assessment of Knee Pain and Function(Assessments will take place within 7 days of the initial clinic visit and within 7 days of the initial postoperative clinic visit, typically one month after surgery.)
- Length of PACU stay(Duration of the patient's stay in the post anesthesia care unit, on average 1 to 5 hours)
- Delayed Cognitive Recovery and Postoperative Neurocognitive Disorder(Assessment will take place on day of enrollment and then at one week (+/- 48 hours) and one month postoperatively (+/- 7 days).)
- Intraoperative and Postoperative Opioids(Duration of the procedure, on average 1 to 3 hours, and up until 72-hours postoperatively)
- Satisfaction with Recovery(Postoperative day one)
- Postoperative Delirium(Measured daily on each postoperative day, starting on postoperative day 1 until postoperative day 7.)
研究者
Brian O'Gara
Assistant Professor of Anaesthesia
Beth Israel Deaconess Medical Center