VR in Neurosurgery: Planning, Training & Communication

NCT06565234 | Recruiting

• 1 other identifier: 2023-02009; ko23Guzman3
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Pathology

Keywords

Intracranial Pathology; Cerebrovascular or Skull Base Pathologies; Neurosurgery; Virtual Reality; Virtual Reality-demonstration; Virtual Reality-assisted Informed Consent

Outcome Measures

Primary Outcomes (5)

• Time for clip application

  Intraoperative timestampf for opening, dissection, aneurysm preparation, clip application and possible clip replacement

  Day 1 (Surgery)

• Virtual Reality-Questionnaire

  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.

  Day 0 (before surgery), >Day 2, Week 4, and Month 6 (after surgery)

• Shared Decision Making Questionnaire (SDM-Q-9)

  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.

  Day 0 (before surgery), >Day 2, Week 4, and Month 6 (after surgery)

• Beck Anxiety Inventory (BAI)

  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.

  Day 0 (before surgery), >Day 2, Week 4, and Month 6 (after surgery)

• Quality of Recovery-15 (QoR-15)

  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.

  Day 0 (before surgery), >Day 2, Week 4, and Month 6 (after surgery)

Secondary Outcomes (5)

• 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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

Study Officials

• Attill Saemann, MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Attill Saemann, MD

CONTACT

+41 61 265 71 24; neurochirurgie@usb.ch

Tabea Stössel, MD

CONTACT

+41 61 265 71 24; neurochirurgie@usb.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: June 10, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 13, 2025

Record last verified: 2025-02

Locations

CH (1)