A Prospective Observational Study on the Integration of Virtual and Augmented Reality in Neurosurgical Planning, Education, and Patient Engagement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time for clip application
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •No informed consent
- •Adult patients without the power of judgement
结局指标
主要结局
Time for clip application
时间窗: Day 1 (Surgery)
Intraoperative timestampf for opening, dissection, aneurysm preparation, clip application and possible clip replacement
Virtual Reality-Questionnaire
时间窗: Day 0 (before surgery), >Day 2, Week 4, and Month 6 (after surgery)
To assess each patient's experience during the consent process, we use the Virtual Reality Questionnaire (VRQ). The VRQ is a numeric scale ranging from 0 (least positive experience) to 10 (most positive experience). Higher scores indicate a better (more positive) outcome in terms of the patient's overall experience. This questionnaire has been specifically customized for the study's focus on virtual reality-based interventions.
Shared Decision Making Questionnaire (SDM-Q-9)
时间窗: Day 0 (before surgery), >Day 2, Week 4, and Month 6 (after surgery)
To assess the individual experience in consenting of the patient, the Shared Decision Making Questionnaire (SDM-Q-9) is used. The SDM-Q-9 is a 9-item questionnaire designed to measure the extent of shared decision-making between patients and healthcare providers. Each item is scored on a 6-point scale from 0 (completely disagree) to 5 (completely agree). Higher scores reflect a greater involvement of the patient in the decision-making process, indicating better shared decision-making practices.
Beck Anxiety Inventory (BAI)
时间窗: Day 0 (before surgery), >Day 2, Week 4, and Month 6 (after surgery)
To assess the individual experience in consenting of the patient, the Beck Anxiety Inventory (BAI) is used. The BAI is a 21-item self-report questionnaire used to assess the severity of an individual's anxiety. Each item is rated on a 4-point scale from 0 (not at all) to 3 (severely, it bothered me a lot). Higher scores indicate higher levels of anxiety, with scores categorized into minimal, mild, moderate, and severe anxiety levels.
Quality of Recovery-15 (QoR-15)
时间窗: Day 0 (before surgery), >Day 2, Week 4, and Month 6 (after surgery)
To assess the individual experience in consenting of the patient, the Quality of Recovery-15 (QoR-15) is used. The QoR-15 is a 15-item questionnaire used to evaluate a patient's recovery after surgery. It covers various aspects of recovery, including physical comfort, emotional state, physical independence, psychological support, and pain. Each item is rated on an 11-point scale from 0 (none of the time) to 10 (all of the time), with higher scores indicating better quality of recovery.
次要结局
- Resources required for 3D visualization(Day 0 (before surgery))
- Length of hospitalization(Up to week 1)
- Modified Rankin Scale (mRS)(>Day 2, Week 4, and Month 6 (after surgery))
- Extended Glasgow Outcome Scale (eGOSE)(>Day 2, Week 4, and Month 6 (after surgery))
- Clip Specifics(d0 (before surgery), d1 (surgery))
研究者
Attill Saemann
Principal Investigator
University Hospital, Basel, Switzerland