Virtual Reality for Patient Informed Consent in Neurosurgery

NCT06627426 | Recruiting

• 1 other identifier: ko24guzman3; 2024-01819
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

VR-based Informed Consent

Outcome Measures

Primary Outcomes (2)

• Comparison of intensity of anxiety between intervention and control group

  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)

  one time assessment at day 1

• Comparison of patient doctor relationship between intervention and control group

  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.

  one time assessment at day 1

Study Arms (2)

VR-based patient informed consent

EXPERIMENTAL

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.

Other: VR-based patient informed consent

Standard of care group

NO INTERVENTION

Group that will receive standard written informed consent

Interventions

VR-based patient informed consent 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.

VR-based patient informed consent

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

Study Officials

• Emilia Westarp, Dr.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raphael Guzman, Prof. Dr.

CONTACT

+41 61 32 87522; raphael.guzman@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, open controlled

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 4, 2024
• Study Start: October 22, 2024
• Primary Completion: October 15, 2025
• Study Completion: October 15, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

CH (1)