Clinical trial NCT06565234: VR in Neurosurgery: Planning, Training & Communication
Official title: A Prospective Observational Study on the Integration of Virtual and Augmented Reality in Neurosurgical Planning, Education, and Patient Engagement
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Pathology
Keywords: Intracranial Pathology
Cerebrovascular or Skull Base Pathologies
Neurosurgery
Virtual Reality
Virtual Reality-demonstration
Virtual Reality-assisted Informed Consent
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated for cerebrovascular or skull base pathologies at the University Hospital Basel or the University Children's Hospital Basel and/or their respective caretakers.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* No informed consent
* Adult patients without the power of judgement

Primary outcomes:
measure: Time for clip application
timeFrame: Day 1 (Surgery)
measure: Virtual Reality-Questionnaire
timeFrame: Day 0 (before surgery), >Day 2, Week 4, and Month 6 (after surgery)
measure: Shared Decision Making Questionnaire (SDM-Q-9)
timeFrame: Day 0 (before surgery), >Day 2, Week 4, and Month 6 (after surgery)
measure: Beck Anxiety Inventory (BAI)
timeFrame: Day 0 (before surgery), >Day 2, Week 4, and Month 6 (after surgery)
measure: Quality of Recovery-15 (QoR-15)
timeFrame: Day 0 (before surgery), >Day 2, Week 4, and Month 6 (after surgery)
Secondary outcomes:
measure: Resources required for 3D visualization
timeFrame: Day 0 (before surgery)
measure: Length of hospitalization
timeFrame: Up to week 1
measure: Modified Rankin Scale (mRS)
timeFrame: >Day 2, Week 4, and Month 6 (after surgery)
measure: Extended Glasgow Outcome Scale (eGOSE)
timeFrame: >Day 2, Week 4, and Month 6 (after surgery)
measure: Clip Specifics
timeFrame: d0 (before surgery), d1 (surgery)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Attill Saemann, MD
role: PRINCIPAL_INVESTIGATOR
References: