Virtual Reality for Patients During Arteriovenous Fistula Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 主要终点
- Perioperative Anxiety
研究概览
简要总结
Patients undergoing arterio-venous fistula commonly experience pain and anxiety due to their pre-operative circumstances and the fact that they remain conscious throughout the surgery. It is well documented that perioperative pain and anxiety can cause detrimental effects on patient outcomes and satisfaction. Virtual reality (VR) is increasingly being investigated as an adjunctive tool in various medical and surgical specialties. Current Evidence suggests that VR can be effective in managing both acute and chronic pain, as well as reducing pain, anxiety, stress, and the need for anesthetic agents during surgery. We hypothesize that using VR during AVF surgery will lead to a reduction in anesthetic doses, decreased patient anxiety and pain, and be favorably received by both surgeons and anesthetists.
详细描述
This is a prospective, interventional study assessing the feasibility, safety, and effectiveness of using Virtual Reality (VR) to reduce anxiety and improve patient experience during arteriovenous fistula (AVF) creation surgery. Patients are recruited pre-operatively and follow standard clinical care protocols, with the addition of VR as an intraoperative intervention.
Participants Eligible patients scheduled for elective AVF creation will be approached for participation. After informed consent, they will undergo standard pre-operative assessment.
Intervention: Virtual Reality Use
The Meta Quest 3™ headset (Meta, California, United States) will be used for the VR intervention. Key features include: Open-ear headphones: Allow patients to hear communication from the anesthesia and surgical teams.
Dimensions: 184 mm x 160 mm x 98 mm. Weight: 515 grams. Display: Fast-switch LCD (2064 × 2208 pixels per eye). Refresh Rate: Adaptive Sync (72-120 Hz). Storage: 512 GB. Content: A 2.5-hour immersive video.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Adults aged ≥18 years scheduled for elective arteriovenous fistula (AVF) creation surgery.
- •Diagnosed with End-Stage Renal Disease (ESRD) and indicated for hemodialysis access.
- •Able to provide informed consent and understand study procedures.
- •Medically stable and cleared for surgery by the anesthesia and surgical teams.
- •Able to wear a virtual reality headset (e.g., no severe claustrophobia or facial injuries preventing use).
排除标准
- •Patients with a history of seizure disorders or epilepsy triggered by visual stimuli.
- •Severe motion sickness, vertigo, or vestibular disorders that may be exacerbated by virtual reality.
- •Significant cognitive impairment or inability to understand instructions or complete questionnaires.
- •Facial or cranial abnormalities or injuries that prevent proper fitting of the VR headset.
- •Patients requiring general anesthesia.
研究组 & 干预措施
Control
Participants randomized to the control arm will receive standard perioperative care for arteriovenous fistula creation, including routine monitoring, local or regional anesthesia, and intraoperative management at the discretion of the anesthesia and surgical teams. No virtual reality intervention will be used. Anxiety, pain, anesthetic requirements, and satisfaction will be assessed at the same pre- and post-operative time points as the intervention group.
Study
Participants randomized to the experimental arm will receive intraoperative virtual reality (VR) in addition to standard perioperative care during arteriovenous fistula creation surgery. The VR headset will be applied either prior to regional anesthesia administration or immediately before surgical preparation, at the discretion of the anesthesia team. Patients will view an immersive relaxation environment throughout the procedure. Standard monitoring, local or regional anesthesia, and intraoperative management will otherwise be identical to the control group. The VR device may be adjusted or removed if clinically indicated. Anxiety, pain, anesthetic requirements, and satisfaction will be assessed at the same pre- and post-operative time points as the control group.
干预措施: Virtual Reality (Device)
结局指标
主要结局
Perioperative Anxiety
时间窗: Pre-operatively (after consent, before surgery) and post-operatively (in the post-anesthesia care unit, approximately 4-6 hours after surgery)
State anxiety will be assessed using the State-Trait Anxiety Inventory (STAI) to measure situational anxiety related to surgery. The State-Trait Anxiety Inventory consists of items rated on a 4-point Likert scale ranging from 1 to 4, where 1 = not at all, 2 = somewhat, 3 = moderately, and 4 = very much so. The total score is calculated by summing item responses, with possible scores ranging from 22 to 88 (for the 22-item version used). Higher scores indicate greater levels of anxiety (i.e., worse outcomes). Positively worded items (e.g., calm, secure, relaxed) were reverse-coded prior to analysis so that higher scores consistently reflect higher anxiety levels
次要结局
- Perioperative Pain(Pre-operatively (after consent, before surgery) and post-operatively (in the post-anesthesia care unit, approximately 4-6 hours after surgery))
- Postoperative Nausea(Pre-operatively (after consent) and post-operatively (in PACU, approximately 4-6 hours after surgery))
- Patient Satisfaction(Post-operatively (in PACU, approximately 4-6 hours after surgery))
- Clinician Feedback(Immediately post-operatively (after patient transfer to PACU))