Actively Recruiting
Virtual Reality for Patient Informed Consent in Neurosurgery - a Randomized Controlled Trial
Led by University Hospital, Basel, Switzerland · Updated on 2025-02-11
34
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of virtual reality (VR) for patient informed consent in neurosurgery. The study aims to assess whether VR improves patients' understanding of complex surgical procedures, their relationship with doctors, and reduces anxiety. The trial also explores the cost-benefit ratio and feasibility of using VR in routine clinical settings, considering the growing role of patient participation in decision-making. Participants will be randomly assigned to one of two groups: the intervention group receiving VR-based informed consent guided by a surgeon, who demonstrates the VR model and assists patients in using the system, or the control group receiving standard written informed consent. The VR process includes explanations of the surgical approach and important anatomical structures relevant to the planned surgery. During the study, patients will be assessed once on the first day for anxiety levels and the patient-doctor relationship. Researchers will measure these outcomes to compare the intervention and control groups. The study involves patients aged 18 to 75 who are undergoing specific neurosurgical procedures. Participation includes undergoing the consent process and completing assessments related to their experience and understanding.
CONDITIONS
Brief Title
Virtual Reality for Patient Informed Consent in Neurosurgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients between the age of 18 and 75
- Scheduled for surgical clipping of intracranial aneurysm or resection of vascular malformations
- Scheduled for craniotomy and resection of intracranial tumors suitable for VR segmentation
You will not qualify if you...
- Visual or auditory impairment that cannot be corrected with sufficient aids
- Previous VR-based informed consent for surgery
- Psychiatric illness or cognitive impairment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive either VR-based patient informed consent guided by a surgeon or standard written informed consent before their neurosurgery. During the VR consent, participants interact with a VR system to better understand their surgical procedure and can ask questions throughout the process.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
University Hospital Basel
Basel, Switzerland, 4031
Actively Recruiting
Research Team
R
Raphael Guzman, Prof. Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Frequently Asked Questions
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