NCT Number: NCT07538687
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: 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
Time frame: Pre-operatively (after consent, before surgery) and post-operatively (in the post-anesthesia care unit, approximately 4-6 hours after surgery)
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.
Time frame: Pre-operatively (after consent) and post-operatively (in PACU, approximately 4-6 hours after surgery)
Nausea will be measured using a 21-point Numeric Rating Scale (NRS) from 0 (no nausea) to 20 (worst imaginable nausea).
Time frame: Post-operatively (in PACU, approximately 4-6 hours after surgery)
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.
Time frame: Immediately post-operatively (after patient transfer to PACU)
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."
Contact information is provided by the study sponsor or research team.
Sir Mortimer B. Davis - Jewish General Hospital
Other
Virtual Reality for Patients During Arteriovenous Fistula Surgery: A Randomized Controlled Trial
Acronym: VR
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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