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NCT Number: NCT06627426

Virtual Reality for Patient Informed Consent in Neurosurgery

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.

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Key information

Conditions

VR-based Informed Consent

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Comparison of intensity of anxiety between intervention and control group

    Time frame: 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)

  2. Comparison of patient doctor relationship between intervention and control group

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Raphael Guzman, Prof. Dr.

CONTACT

[email protected]

+41 61 32 87522

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Virtual Reality for Patient Informed Consent in Neurosurgery - a Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 4, 2024
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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