VR Study Virtual Reality for Patients During Arteriovenous Fistula Surgery (VR)

Virtual Reality for Patients During Arteriovenous Fistula Surgery: A Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: End Stage Renal Disease on Dialysis
• Intervention / Treatment: Device: Virtual Reality

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Otgon Baatar, PhD; Phone Number: 438-932-0313; Email: otgon.baatar@mail.mcgill.ca
• Study Contact Backup: Name: Marie-Amélie PhD Lukaszewski, PhD; Phone Number: 76134 1 514-934-1934; Email: marie-amelie.lukaszewski@muhc.mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Device: Virtual Reality; Immersive virtual reality delivered via head-mounted display providing a relaxation-based audiovisual environment intended to reduce perioperative anxiety and pain perception during surgery.; Other Names: The Meta Quest 3™ headset (Meta, California, United States)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative Anxiety	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	Pre-operatively (after consent, before surgery) and post-operatively (in the post-anesthesia care unit, approximately 4-6 hours after surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative Pain	Pain will be assessed using a 21-point Numeric Rating Scale (NRS) from 0 (no pain) to 20 (worst imaginable pain) at pre- and post-operative time points.	Pre-operatively (after consent, before surgery) and post-operatively (in the post-anesthesia care unit, approximately 4-6 hours after surgery)
Postoperative Nausea	Nausea will be measured using a 21-point Numeric Rating Scale (NRS) from 0 (no nausea) to 20 (worst imaginable nausea).	Pre-operatively (after consent) and post-operatively (in PACU, approximately 4-6 hours after surgery)
Patient Satisfaction	Patient satisfaction with the surgical experience and the VR intervention will be evaluated using a structured survey, assessing overall comfort, perceived benefit, and acceptance of the intervention. Patient satisfaction will be assessed using structured ordinal scales. Satisfaction with VR and likelihood to recommend VR were measured using 7-point Likert-type scales (range: 1-7), where higher scores indicate more favorable responses. Willingness to use VR in future procedures was measured on a percentage scale ranging from 0% to 100%. An open-ended question was included to capture additional qualitative feedback.	Post-operatively (in PACU, approximately 4-6 hours after surgery)
Clinician Feedback	anesthetist feedback will be collected immediately after surgery using a structured questionnaire evaluating safety, feasibility, interference with care, patient response, and openness to future VR use. The anesthesiologist perception questionnaire will use a 5-point Likert scale ranging from 1 to 5, where 1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, and 5 = strongly agree. For all Likert-scale items (Questions 1-7), higher scores indicate a more positive perception of virtual reality (VR) use, including greater acceptability, feasibility, perceived safety, and clinical utility. All Likert items were phrased such that higher scores consistently reflect more favorable outcomes; therefore, no reverse coding was required. Additional items (Questions 8-10) were qualitative or dichotomous (yes/no) and will be analyzed descriptively."	Immediately post-operatively (after patient transfer to PACU)

Collaborators and Investigators

• Sponsor: Sir Mortimer B. Davis - Jewish General Hospital
• Collaborators: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Investigators: Principal Investigator: Elie Girsowicz, MD, MSc, McGill

Publications and helpful links

General Publications

• Genç H, Korkmaz M, Akkurt A. The Effect of Virtual Reality Glasses and Stress Balls on Pain and Vital Findings During Transrectal Prostate Biopsy: A Randomized Controlled Trial. J Perianesth Nurs. 2022;37(3):344-50.
• Liu Q, Zang Y, Zang W, Cai W, Li W, Guo Y, et al. Implementation of virtual reality technology to decrease patients' pain and nervousness during colonoscopies: a prospective randomised controlled single-blinded trial. Clin Med (Lond). 2022;22(3):237-40.
• Falguière A, LeGruiec C, Herry H, Genest-Beucher S, Dessus JM, Boisramé S. Contribution of virtual reality in oral surgery: A literature review. J Stomatol Oral Maxillofac Surg. 2021;122(4):405-410. doi:10.1016/j.jormas.2021.01.002

Helpful Links

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Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: MP-05-2026-4752

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified individual participant data (IPD) from this study, including demographic information, perioperative anxiety scores (STAI), pain and nausea scores (NRS), anesthetic doses, and patient satisfaction responses, will be made available to qualified researchers. Data will be shared upon reasonable request following publication of the primary results, after approval by the study's principal investigator and institutional review board. Requests should include a clear research proposal and data use plan. Data will be provided through a secure, password-protected repository, and researchers will be required to sign a data use agreement to ensure confidentiality and limit use to the approved research purpose.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No