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Informed consent through 3D virtual reality: a randomized clinical trial.

Alessandro Perin^1,2,3, Tommaso Francesco Galbiati^4,5, Roberta Ayadi^4,5

¹Neurosurgery Department, Fondazione IRCCS Istituto Neurologico Nazionale "C. Besta", Milan, Italy. aperin@gmail.com.

Acta Neurochirurgica

|April 4, 2020

Summary

Immersive 3D virtual reality significantly improved patient understanding of surgical procedures compared to traditional methods. This enhanced informed consent process did not increase patient anxiety, fostering better surgeon-patient relationships.

Keywords:

Communication Informed consent Malpractice Virtual reality

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Area of Science:

Medical Imaging
Surgical Planning
Patient Education

Background:

Informed consent is crucial for patient understanding and trust, aiming to reduce anxiety.
Traditional 2D imaging may not fully convey complex surgical information.
Immersive 3D imaging technologies offer potential to enhance the informed consent process.

Purpose of the Study:

To evaluate the effectiveness of immersive 3D imaging in surgical informed consent.
To compare patient comprehension and anxiety levels between 3D and 2D informed consent methods.
To assess the impact of 3D virtual reality on surgeon-patient relationships.

Main Methods:

A prospective, single-center, randomized controlled trial (SPLICE Study) enrolled 40 patients undergoing intracranial tumor surgery.
33 patients were randomized into three groups: two experimental groups received 3D immersive informed consent, and one control group received traditional 2D imaging consent.
Patient objective comprehension, subjective comprehension, and anxiety levels were measured.

Main Results:

Patients in the 3D immersive consent groups showed significantly higher objective comprehension scores (mean scores 82.65 and 77.76) compared to the 2D control group (57.70; P < 0.001).
Subjective comprehension and anxiety levels did not significantly differ between the 3D and 2D groups.
Patients in the experimental groups appreciated the 3D communication experience.

Conclusions:

Immersive 3D virtual reality enhances patient comprehension of surgical conditions and procedures.
This technology improves the informed consent process without increasing patient anxiety.
3D virtual reality may foster trust between surgeons and patients, potentially reducing medical-legal issues.