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Recruiting NCT06565234

VR in Neurosurgery: Planning, Training & Communication

Observational Brain Pathology

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Brain Pathology. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Time for clip application [Time frame: Day 1 (Surgery)]
  • Virtual Reality-Questionnaire [Time frame: Day 0 (before surgery), >Day 2, Week 4, and Month 6 (after surgery)]
  • Shared Decision Making Questionnaire (SDM-Q-9) [Time frame: Day 0 (before surgery), >Day 2, Week 4, and Month 6 (after surgery)]
  • Beck Anxiety Inventory (BAI) [Time frame: Day 0 (before surgery), >Day 2, Week 4, and Month 6 (after surgery)]
  • Quality of Recovery-15 (QoR-15) [Time frame: Day 0 (before surgery), >Day 2, Week 4, and Month 6 (after surgery)]
Secondary outcome measures (5)
  • Resources required for 3D visualization [Time frame: Day 0 (before surgery)]
  • Length of hospitalization [Time frame: Up to week 1]
  • Modified Rankin Scale (mRS) [Time frame: >Day 2, Week 4, and Month 6 (after surgery)]
  • Extended Glasgow Outcome Scale (eGOSE) [Time frame: >Day 2, Week 4, and Month 6 (after surgery)]
  • Clip Specifics [Time frame: d0 (before surgery), d1 (surgery)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Switzerland · 1 center
  • University Hospital Basel — Basel

Identifiers

NCT: NCT06565234 · 2023-02009; ko23Guzman3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗