Oral Surgery Virtual Reality Glasses Study

Официальное название

Investigating the Impact of Virtual Reality Glasses on Sedation Requirement and Patient Experience in Patients Undergoing Oral Surgery

Обзор

The goal of this randomized trial is to investigate if using virtual reality (VR) glasses for patients who require non-emergent oral surgery procedures under intravenous (IV) sedation improves their overall experience compared to using standard of care safety glasses. This study has two primary objectives. 1. To evaluate if VR glasses can improve patient tolerance during IV access, sedation induction, and the surgical procedure. 2. To investigate whether the use of VR glasses reduces the amount of sedation required for induction and throughout the oral surgery procedure. 80 subjects will be randomly assigned 1:1 to either wear VR glasses playing a relaxing video and audio or VR glasses that will only serve as eye protection (control group).

Вмешательства

• Другое Virtual reality (VR) glasses with relaxation module
  The relaxation module will include immersive video and audio components as a distraction from the medical procedures.

Первичные конечные точки

• Level of anxiety [Срок оценки: 3 days before oral surgery, immediately before surgery, immediately after surgery, about 8 hours after surgery]
• Level of depression [Срок оценки: 3 days before oral surgery, immediately before surgery, immediately after surgery, about 8 hours after surgery]
• Amount of Midazolam used [Срок оценки: pre-incision, 30 minutes post incision, 60 minutes post incision]
• Amount of Fentanyl used [Срок оценки: pre-incision, 30 minutes post incision, 60 minutes post incision]
• Amount of Propofol used [Срок оценки: pre-incision, 30 minutes post incision, 60 minutes post incision]
• Amount of Ketamine used [Срок оценки: pre-incision, 30 minutes post incision, 60 minutes post incision]

Критерии участия

Критерии включения

• Patients requiring IV sedation for oral surgery procedure
• Patients able to understand the use of virtual reality glasses and provide informed consent/assent
• Patients classified as American Society of Anesthesiologists (ASA) I or II
• No reported substance use within the previous 24 hours
• No reported excessive alcohol consumption
• Willingness to wear eye protection
• Willingness to use certified interpreters if required
• A legal guardian must accompany minors

Критерии исключения

• Patient with hearing aids or severe hearing impairment
• Patient with blindness or significant visual impairment that is not corrected by contact lenses
• Patients with cognitive impairments determined and assessed by the researchers
• Pregnant women or women who could be pregnant based on self reporting
• Patients unable to tolerate virtual reality glasses due to motion sickness or other issues
• Patients with history of seizures or epilepsy per self report
• Patients who cannot tolerate VR glasses due to discomfort or a medical emergency that arises during the procedure

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

Профилактика

Центры проведения

США · 1 центр

• Goldman School of Dental Medicine, Oral and Maxillofacial Surgery Clinic — Boston

Идентификаторы

NCT: NCT06723158 · H-45038

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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