Virtual Reality for Patient Informed Consent in Neurosurgery

NCT ID: NCT06627426

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-22
• Study Completion Date: 2025-10-15

Brief Summary

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.

Conditions

VR-based Informed Consent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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 and enable them to use the VR system by themselves.

Group Type: EXPERIMENTAL

VR-based patient informed consent

Intervention Type: OTHER

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.

Standard of care group

Group that will receive standard written informed consent

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emilia Westarp, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

University Hospital Basel

Basel, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Raphael Guzman, Prof. Dr.

Role: CONTACT

raphael.guzman@usb.ch

+41 61 32 87522

Facility Contacts

Emilia Westarp, Dr. med.

Role: primary

emilia.westarp@usb.ch

+41 61 32 87187

Raphael Guzman, Prof. Dr.

Role: backup

raphael.guzman@usb.ch

+41 61 32 87522

Other Identifiers

ko24guzman3; 2024-01819

Identifier Type: -

Identifier Source: org_study_id