Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-26 @ 1:04 AM
Study NCT ID:
NCT06565234
Status:
RECRUITING
Last Update Posted:
2025-03-13
First Post:
2024-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
VR in Neurosurgery: Planning, Training & Communication
Sponsor:
University Hospital, Basel, Switzerland
Organization:
Study Overview
Official Title:
A Prospective Observational Study on the Integration of Virtual and Augmented Reality in Neurosurgical Planning, Education, and Patient Engagement
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: