Virtual Reality for Patient Informed Consent in Neurosurgery

Not Applicable

Recruiting

• Conditions: VR-based Informed Consent

• Registration Number: NCT06627426
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study First Submitted: 2024-10-02
• Study First Submitted QC: 2024-10-02
• Study First Posted: 2024-10-04
• Study Start: 2024-10-22
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-11
• Primary Completion: 2025-10-15
• Study Completion: 2025-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparison of intensity of anxiety between intervention and control group	one time assessment at day 1	Comparison of intensity of physical and cognitive anxiety symptoms will be assessed by the questionnaire Beck Anxiety Inventory (BAI). This questionnaire consists of 21 self-reported items (four-point scale).; min score: 39 (minimal anxiety level) max score:174 (severe anxiety)
Comparison of patient doctor relationship between intervention and control group	one time assessment at day 1	Comparison of patient doctor relationship will be assessed by PDRQ9 (patient-doctor relationship questionnaire). The questionnaire is a 9-item scale that assesses patients' perception of the relationship with the physician. Items are scored on a 5-point Likert scale ranging from 'not at all appropriate' to 'totally appropriate'. Raw sum scores range from 9 to 45, with higher scores indicating that the patient's perception of the patient-doctor relationship is more favorable.

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland