Feasibility of a Multimodal Virtual Reality Intervention to Reduce Preoperative Anxiety in Cancer Surgery Patients

Обзор

The goal of this study is to assess the feasibility of an expanded virtual reality (VR) intervention designed to help prepare patients for cancer surgery. This study will: (1) assess the investigator's ability to recruit, retain, and engage participants, (2) evaluate how acceptable participants find the intervention through their feedback on its individual components. The investigators will also explore whether baseline anxiety levels or psychiatric history predict responses to the intervention, as well as look for any changes in perioperative anxiety and monitoring for any adverse effects associated with the intervention. This study will also investigate engagement of providing participants with a first-person VR session recordings to determine utility and whether post-session access is perceived as beneficial. Finally, preliminary pilot outcomes will examine whether increased engagement in the VR results in reductions in anxiety on the day of surgery.

Вмешательства

• Устройство Virtual Reality
  The VR simulation involves the experience of prepping, waiting, receiving, and recovering from surgery at a large tertiary care centre in Central Canada. It is designed to prepare patients for cancer surgery by increasing familiarity with the hospital environment, providing the opportunity to "experience" restricted areas of the hospital that patients cannot access until the day of the surgery, and better understand the surgical process. The simulation was originally developed for a prior resear

Первичные конечные точки

• Engagement [Срок оценки: Day 0 post-intervention]
• Acceptability [Срок оценки: Day 0 post-intervention]

Вторичные конечные точки (10)

• Anxiety [Срок оценки: Baseline]
• Depression [Срок оценки: Baseline]
• Pre-Operative Anxiety [Срок оценки: Baseline and re-administered pre-operatively on the day of surgery]
• Pre-Operative Anxiety [Срок оценки: Baseline]
• Pre-Operative Anxiety [Срок оценки: Baseline and re-administered pre-operatively on the day of surgery.]
• Pre-Operative Distress [Срок оценки: Baseline and re-administered pre-operatively on the day of surgery]
• Cybersickness [Срок оценки: Day 0 post-intervention]
• Presence [Срок оценки: Day 0 post-intervention]
• Perceived Usability of Device [Срок оценки: Day 0 post-intervention]
• Engagement & Adherence - Standardized Video [Срок оценки: Day 1 up to Day 14]

Критерии участия

Patients will be deemed eligible for inclusion if they: (a) are 18 years of age or older; (b) are able to speak and read English; (c) have received a cancer diagnosis; and (d) are scheduled, or in the process of being scheduled to undergo oncological surgery under general anesthesia at the Health Sciences Centre Winnipeg. Patients will be deemed ineligible if they are unable to provide informed consent (e.g., due to cognitive impairment) or if they have any visual, auditory and/or motor impairments that would preclude effective participation in the Virtual Reality intervention.

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

Простое слепое

Основная цель

Оценка устройства

Центры проведения

Канада · 1 центр

• Health Sciences Centre — Winnipeg

Идентификаторы

NCT: NCT07366515 · 0414

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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