About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Virtual Reality
DeviceImmersive virtual reality delivered via head-mounted display providing a relaxation-based audiovisual environment intended to reduce perioperative anxiety and pain perception during surgery.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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.
Postoperative Nausea
Nausea will be measured using a 21-point Numeric Rating Scale (NRS) from 0 (no nausea) to 20 (worst imaginable nausea).
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.
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."
Locations
Sponsors and contacts
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Sir Mortimer B. Davis - Jewish General Hospital
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborator
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