End Stage Renal Disease on DialysisVRNCT07538687
VR Study Virtual Reality for Patients During Arteriovenous Fistula Surgery
A study testing Virtual Reality in people with End Stage Renal Disease on Dialysis, run by Sir Mortimer B. Davis - Jewish General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease on Dialysis
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Marie-Amélie PhD Lukaszewski, PhD contact
About this study
Official title: 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.
Read the 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.
- Conditions
- End Stage Renal Disease on Dialysis
- Being tested
- Virtual Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Also called The Meta Quest 3™ headset (Meta, California, United States)
Immersive virtual reality delivered via head-mounted display providing a relaxation-based audiovisual environment intended to reduce perioperative anxiety and pain perception during surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: 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).
Measured: 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.
Measured: 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."
Measured: Immediately post-operatively (after patient transfer to PACU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Disease on DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Responsible party
- Sponsor
- Investigators
- Elie Girsowicz, MD, MSc, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538687
- Sponsor's protocol ID
- MP-05-2026-4752
- Acronym
- VR
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Genc 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 Jun;37(3):344-350. doi: 10.1016/j.jopan.2021.09.006. Epub 2022 Apr 7.
PubMed 35397973Liu Q, Zang Y, Zang W, Cai W, Li W, Guo Y, Xin C, Tu X. Implementation of virtual reality technology to decrease patients' pain and nervousness during colonoscopies: a prospective randomised controlled single-blinded trial. Clin Med (Lond). 2022 May;22(3):237-240. doi: 10.7861/clinmed.2022-0001. Epub 2022 Apr 20.
PubMed 35443967Falguiere A, LeGruiec C, Herry H, Genest-Beucher S, Dessus JM, Boisrame S. Contribution of virtual reality in oral surgery: A literature review. J Stomatol Oral Maxillofac Surg. 2021 Sep;122(4):405-410. doi: 10.1016/j.jormas.2021.02.004. Epub 2021 Feb 18.
PubMed 33610770
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality for Patients During Arteriovenous Fistula Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07538687
- Acronym / sponsor ID
- VR / MP-05-2026-4752
- Conditions
- End Stage Renal Disease on Dialysis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General HospitalUniversity, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Virtual RealityParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityAlso: The Meta Quest 3™ headset (Meta, California, United States)Immersive virtual reality delivered via head-mounted display providing a relaxation-based audiovisual environment intended to reduce perioperative anxiety and pain perception during surgery. | Device | Study |
Primary outcome
Perioperative Anxiety
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
4 secondary outcomes
Perioperative Pain
Time frame: Pre-operatively (after consent, before surgery) and post-operatively (in the post-anesthesia care unit, approximately 4-6 hours after surgery)
Postoperative Nausea
Time frame: Pre-operatively (after consent) and post-operatively (in PACU, approximately 4-6 hours after surgery)
Patient Satisfaction
Time frame: Post-operatively (in PACU, approximately 4-6 hours after surgery)
Clinician Feedback
Time frame: Immediately post-operatively (after patient transfer to PACU)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Background: PubMed 35397973Genc 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 Jun;37(3):344-350. doi: 10.1016/j.jopan.2021.09.006. Epub 2022 Apr 7.
- Background: PubMed 35443967Liu Q, Zang Y, Zang W, Cai W, Li W, Guo Y, Xin C, Tu X. Implementation of virtual reality technology to decrease patients' pain and nervousness during colonoscopies: a prospective randomised controlled single-blinded trial. Clin Med (Lond). 2022 May;22(3):237-240. doi: 10.7861/clinmed.2022-0001. Epub 2022 Apr 20.
- Results publication: PubMed 33610770Falguiere A, LeGruiec C, Herry H, Genest-Beucher S, Dessus JM, Boisrame S. Contribution of virtual reality in oral surgery: A literature review. J Stomatol Oral Maxillofac Surg. 2021 Sep;122(4):405-410. doi: 10.1016/j.jormas.2021.02.004. Epub 2021 Feb 18.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie-Amélie PhD Lukaszewski, PhD contact
Elie Girsowicz, MD, MSc principal investigator
McGill University
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with End Stage Renal Disease on Dialysis, run by Sir Mortimer B. Davis - Jewish General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Otgon Baatar, PhD (438-932-0313, otgon.baatar@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative Anxiety (time frame: Pre-operatively (after consent, before surgery) and post-operatively (in the post-anesthesia care unit, approximately 4-6 hours after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07538687, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.