Virtual Reality for Patient Informed Consent in Neurosurgery

University Hospital Basel

Status: Enrolling

Conditions: VR-based Informed Consent

Treatments: Other: VR-based patient informed consent

Study type: Interventional

Funder types: Other

Identifiers

NCT06627426

ko24guzman3 2024-01819;

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

VR-based patient informed consent

Experimental group

Description:

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 and enable them to use the VR system by themselves.

Treatment:

Other: VR-based patient informed consent

Standard of care group

No Intervention group

Description:

Group that will receive standard written informed consent