Идёт набор NCT06565234

VR in Neurosurgery: Planning, Training & Communication

— Наблюдательное Brain Pathology

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Brain Pathology. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Швейцария
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Prospective Observational Study on the Integration of Virtual and Augmented Reality in Neurosurgical Planning, Education, and Patient Engagement

Обзор

This prospective study analyzes the broad impact of virtual reality (VR) assistance on aneurysm surgeries through two primary focuses: first, it evaluates VR-assisted clip planning by examining its clinical outcomes in the operative management of aneurysms, and second, it investigates the role of VR-assisted patient-informed consent, including its effects on patient comprehension, the patient-doctor relationship, and anxiety.

Подробное описание

Over the last years, increasing innovations and accessibility to virtual reality (VR) and augmented reality (AR) technologies have contributed to the relevance of these tools in daily life and medical research activities. Surgical specialties play a key role in introducing these technologies into clinical practice, with additional applications and research fields.

In neurosurgery, VR-based surgical planning for aneurysm management has shown the potential to enhance patient safety, reduce surgery times, and improve clinical outcomes. Recently, a few studies have shown that patients can also benefit from using VR applied to IC, although the current patient-oriented use of VR remains scarce.

With the increasing demand for concepts like shared decision-making and patient-centered care, optimal IC is more relevant than ever. A pilot study (NCT) on VR-based IC at the investigators' institution demonstrated feasibility and indicated positive outcomes based on the investigators' questionnaire. Building on these findings, this prospective study aims to evaluate the broad impact of VR assistance on aneurysm surgeries by focusing on two main aspects: VR-assisted clip planning, including its effects on patient safety, operative times, and clinical outcomes, and VR-assisted patient-informed consent, examining subjective patient comprehension, the patient-doctor relationship, and anxiety. Additionally, the study will assess the cost-benefit ratio and feasibility of VR-based approaches in a routine clinical setting. Ultimately, VR may foster a better understanding of complex procedures, optimize the perioperative process for both patient and surgeon, reduce anxiety, and improve patient safety.

Первичные конечные точки

Time for clip application [Срок оценки: Day 1 (Surgery)]
Virtual Reality-Questionnaire [Срок оценки: Day 0 (before surgery), >Day 2, Week 4, and Month 6 (after surgery)]
Shared Decision Making Questionnaire (SDM-Q-9) [Срок оценки: Day 0 (before surgery), >Day 2, Week 4, and Month 6 (after surgery)]
Beck Anxiety Inventory (BAI) [Срок оценки: Day 0 (before surgery), >Day 2, Week 4, and Month 6 (after surgery)]
Quality of Recovery-15 (QoR-15) [Срок оценки: Day 0 (before surgery), >Day 2, Week 4, and Month 6 (after surgery)]

Вторичные конечные точки (5)

Resources required for 3D visualization [Срок оценки: Day 0 (before surgery)]
Length of hospitalization [Срок оценки: Up to week 1]
Modified Rankin Scale (mRS) [Срок оценки: >Day 2, Week 4, and Month 6 (after surgery)]
Extended Glasgow Outcome Scale (eGOSE) [Срок оценки: >Day 2, Week 4, and Month 6 (after surgery)]
Clip Specifics [Срок оценки: d0 (before surgery), d1 (surgery)]

Критерии участия

Критерии включения

The patient is able to give written consent (or written consent by legal representative)
Preoperative imaging demonstrating intracranial pathology
Cognitively able to provide answers for the questionnaires