Virtual Reality for Patient Informed Consent in Neurosurgery
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
- The protocol lists: VR-based patient informed consent.
- Who it may be relevant to
- Registry conditions: VR-based Informed Consent. Basic parameters: 18 years — 75 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 →
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Official title
Virtual Reality for Patient Informed Consent in Neurosurgery - a Randomized Controlled Trial
Overview
The goal of this randomized controlled trial is to evaluate benefits of VR (virtual reality)-based patient informed consent in neurosurgery regarding subjective patient comprehension, patient-doctor relationship and anxiety.
Detailed description
Additionally, the investigators aim to assess the cost-benefit radio as well as feasibility in a clinical routine setting. Considering the increasing patient participation in decision-making, VR could lead to better understanding of complex surgical procedures, improving the perioperative process for both, patient and surgeon, and reduce anxiety.
Interventions
- Other VR-based patient informed consent
The "intervention" group will be the on receiving VR-based patient informed consent. One surgeon from the study team will be guiding the patient through their VR model first with demonstration of the technology and the model, afterwards the patient will be enabled to use the VR system by themselves. During the whole process the patient will be able to ask questions. Depending on the planned surgery, the surgical approach as well important anatomical structures will be explained.
Primary outcome measures
- Comparison of intensity of anxiety between intervention and control group [Time frame: one time assessment at day 1]
- Comparison of patient doctor relationship between intervention and control group [Time frame: one time assessment at day 1]
Eligibility criteria
Inclusion criteria
- Patients between the age of 18 and 75
- Surgical clipping for intracranial aneurysm, resection of vascular malformations
- Craniotomy and Resection of intracranial tumors that can be segmented for VR
Exclusion criteria
- Visual or auditory impairment with no sufficient aid
- Patient that had VR informed consent for surgery before
- Psychiatric illness, cognitive impairment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Switzerland · 1 center
- University Hospital Basel — Basel
Identifiers
NCT: NCT06627426 · ko24guzman3; 2024-01819