Virtual Reality for Patient Informed Consent in Neurosurgery

Not Applicable

Not yet recruiting

• Conditions: VR-based Informed Consent
• Interventions: Other: VR-based patient 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

• Status Verified: 2024-10
• Study First Submitted: 2024-10-02
• Study First Submitted QC: 2024-10-02
• Study First Posted: 2024-10-04
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08
• Study Start: 2024-10-15
• Primary Completion: 2025-10-15
• Study Completion: 2025-10-15

Recruitment & Eligibility

• Status: NOT_YET_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

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Exclusion Criteria

• Visual or auditory impairment with no sufficient aid
• Patient that had VR informed consent for surgery before
• Psychiatric illness, cognitive impairment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VR-based patient informed consent	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.

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