VR Study Virtual Reality for Patients During Arteriovenous Fistula Surgery

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Perioperative Anxiety [Срок оценки: Pre-operatively (after consent, before surgery) and post-operatively (in the post-anesthesia care unit, approximately 4-6 hours after surgery)]

Вторичные конечные точки (4)

• Perioperative Pain [Срок оценки: Pre-operatively (after consent, before surgery) and post-operatively (in the post-anesthesia care unit, approximately 4-6 hours after surgery)]
• Postoperative Nausea [Срок оценки: Pre-operatively (after consent) and post-operatively (in PACU, approximately 4-6 hours after surgery)]
• Patient Satisfaction [Срок оценки: Post-operatively (in PACU, approximately 4-6 hours after surgery)]
• Clinician Feedback [Срок оценки: Immediately post-operatively (after patient transfer to PACU)]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 35397973
• Liu 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. PMID 35443967
• Falguiere 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. PMID 33610770

Идентификаторы

NCT: NCT07538687 · MP-05-2026-4752

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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