Postoperative Virtual Reality (VR) for Recovery After Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Quality of Recovery Questionnaires (QoR-15)
研究概览
简要总结
The objective of this study is to investigate whether the addition of immersive virtual reality (VR) in the immediate postoperative period to an enhanced recovery after surgery (ERAS) protocol could improve postoperative recovery from bariatric surgery.
详细描述
The investigators propose conducting a randomized, controlled, single-center clinical trial of patients recovering from laparoscopic bariatric surgery. The objective is to investigate whether the use of virtual reality (VR) during the immediate postoperative period could improve patient reported quality of recovery and potentially reduce opioid analgesic requirements as compared to an existing ERAS protocol.
The investigators hypothesize that immersive VR will improve subjective quality of recovery scores at time of Post Anesthesia Care Unit (PACU) discharge as compared to standard ERAS.
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 QOR15 recovery scale will be blinded to group assignment.
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 laparoscopic bariatric surgery at BIDMC under general anesthesia.
排除标准
- •Open wounds or active infection of the face or eye area
- •History of seizures or other symptom linked to an epileptic condition
- •Patients with hearing aids who are unable to tolerate wearing headphones with their hearing aids
- •Patients with a pacemaker or other implanted medical device
- •Droplet or airborne precautions (as determined by BIDMC infection control policy)
- •Non English Speaking or non Spanish Speaking
- •Chronic opioid dependence (existing oral opioid prescription for >3 months, methadone, suboxone)
- •Drop Out Criteria: (after enrollment and randomization, before intervention)
- •- Surgery is converted to an open procedure (laparotomy), the patient will be withdrawn from the study as these patients are treated in a manner that is different than standard ERAS protocols
研究组 & 干预措施
Enhanced recovery after surgery protocol
Subjects in the control group will only undergo standard enhanced recovery after surgery care.
Immersive Virtual Reality plus the enhanced recovery after surgery protocol
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 in the post anesthesia care unit (PACU) after surgery. 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.
Patients in the VR group will also be treated according to the existing enhanced recovery after surgery protocol.
干预措施: Virtual Reality Immersive Relaxation (Other)
结局指标
主要结局
Quality of Recovery Questionnaires (QoR-15)
时间窗: Measured at time of post anesthesia care unit discharge, on average of 1 to 5 hours after surgery.
The primary outcome of this study will be patient reported quality of recovery at time of PACU discharge, as assessed by the QOR-15. The QOR-15 is a validated instrument to assess postoperative recovery from the patient's perspective, assessing overall well-being, nausea, pain, and anxiety and depression following surgery.
次要结局
- PACU Opioid Requirements(Measured throughout a patient's stay in the post anesthesia care unit, on average 1 to 5 hours after surgery.)
- Postoperative Quality of Recovery Questionnaires (QoR-15) score(Measured at 24 hours after post anesthesia unit discharge.)
- Opioid-related adverse effects(Measured throughout the patients stay at the hospital, on average 1 to 3 days.)
- Length of PACU stay(Duration of the patient's stay in the post anesthesia care unit, from time of admission to time of readiness for PACU discharge, on average 1 to 5 hours.)
- Hospital length of stay(Measured throughout the patients stay at the hospital, on average 1 to 3 days.)
- PACU pain scores using numeric rating scale(Administered every hour following admission to the post anesthesia care unit until discharge from the post anesthesia care unit, on average 1 to 5 hours.)
- Opioid requirements(Measured throughout the patients stay at the hospital, on average 1 to 3 days.)
研究者
Brian O'Gara
Assistant Professor of Anaesthesia
Beth Israel Deaconess Medical Center