Informed Consent Through 3D Virtual Reality: A Randomized Clinical Trial

Informed Consent Through 3D Virtual Reality: A Randomized Clinical Trial
Alessandro Perin, Tommaso Francesco Galbiati, Roberta Ayadi, Enrico Gambatesa, Eleonora Francesca Orena, Nicole Irene Riker, Hagit Silberberg, Donatella Sgubin, Torstein Ragnar Meling, Francesco DiMeco
Acta Neurochirurgica, 3 April 2020
Abstract
Background
The informed consent is a defining moment that should allow patients to understand their condition, what procedure they are undergoing, and what consequences may follow. This process should foster trust and promote confidence, without increasing patients’ anxiety. New immersive 3D imaging technologies may serve as a tool to facilitate this endeavor.
Methods
In a prospective, single-center, randomized controlled clinical trial (SPLICE Study: Surgical Planning and Informed Consent Study; ClinicalTrials.gov NCT03503487), 40 patients undergoing surgery for intracranial tumors were enrolled. After undergoing a traditional surgical informed consent acquisition, 33 patients were randomized 1:1:1 to 3 groups: in 2 experimental groups, patients underwent a 3D, immersive informed consent with two different surgical planners (group 1 and group 2); in the control group, patients underwent an informed consent supported by traditional 2D radiological images.
Results
Patients in the experimental groups appreciated this communication experience, while their objective comprehension was higher ((score mean (SD)): group 1 82.65 (6.83); group 2 77.76 (10.19)), as compared with the control group (57.70 (12.49); P < 0.001). Subjective comprehension and anxiety levels did not differ between experimental groups and control group.
Conclusions
3D virtual reality can help surgeons and patients in building a better relationship before surgery; immersive 3D-supported informed consent improves patients’ comprehension of their condition without increasing anxiety. This new paradigm may foster trust between surgeons and patients, possibly restraining medical-legal acts.

Editor’s note: Acta Neurochirurgica is an Austrian journal.

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