VR Study Virtual Reality for Patients During Arteriovenous Fistula Surgery

Sir Mortimer B. Davis - Jewish General Hospital

Status: Not yet enrolling

Conditions: End Stage Renal Disease on Dialysis

Treatments: Device: Virtual Reality

Study type: Interventional

Funder types: Other

Identifiers

NCT07538687

MP-05-2026-4752

Details and patient eligibility

About

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.

Full description

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.

Custom face pads will be used to accommodate patients wearing glasses and to reduce light interference from the operating room environment.

The VR headset will be fitted either before nerve block administration, at the discretion of the anesthesia team, or immediately before surgical prepping and draping.

Throughout the procedure, the headset will be monitored by the resident investigator or a member of the anesthesia team, who can adjust or remove the device if needed. In case of patient discomfort (e.g., dizziness, nausea, VR-related pain), appropriate medications will be administered as per standard practice.

Sterility and Equipment Handling The VR headset is small enough to fit under surgical drapes without impeding sterility or interfering with the operative field. After each use, the headset will be disinfected using hospital-grade sanitizing wipes by the resident investigator.

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Control

No Intervention group

Description:

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

Experimental group

Description:

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.

Treatment:

Device: Virtual Reality