VR Study Virtual Reality for Patients During Arteriovenous Fistula Surgery

NCT07538687 | Not Yet Recruiting

• 1 other identifier: MP-05-2026-4752
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

End Stage Renal Disease on Dialysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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)

Study Arms (2)

Control

NO INTERVENTION

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

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

Interventions

Virtual Reality DEVICE

Immersive virtual reality delivered via head-mounted display providing a relaxation-based audiovisual environment intended to reduce perioperative anxiety and pain perception during surgery.

Also known as: The Meta Quest 3™ headset (Meta, California, United States)

Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital: lead
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator

Related Publications (3)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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

  RESULT

Related Links

• Related Info
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Study Officials

• Elie Girsowicz, MD, MSc

  McGill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Otgon Baatar, PhD

CONTACT

438-932-0313; otgon.baatar@mail.mcgill.ca

Marie-Amélie PhD Lukaszewski, PhD

CONTACT

1 514-934-1934; marie-amelie.lukaszewski@muhc.mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, randomized, parallel-assignment study. Eligible patients undergoing elective arteriovenous fistula creation will be randomized to receive either intraoperative VR in addition to standard anesthetic care or standard anesthetic care alone. No crossover will occur. Perioperative anxiety, pain, anesthetic use, and satisfaction outcomes will be assessed pre- and post-operatively and compared between groups.

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: April 20, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share