Alessandro Perin1,2,3, Tommaso Francesco Galbiati4,5, Roberta Ayadi4,5, Enrico Gambatesa4,5, Eleonora Francesca Orena4,5, Nicole Irene Riker4,5, Hagit Silberberg5, Donatella Sgubin6, Torstein Ragnar Meling5,7, Francesco DiMeco4,5,8,9. 1. Neurosurgery Department, Fondazione IRCCS Istituto Neurologico Nazionale "C. Besta", Milan, Italy. aperin@gmail.com. 2. Besta NeuroSim Center, Fondazione IRCCS Istituto Neurologico Nazionale "C. Besta", Milan, Italy. aperin@gmail.com. 3. Department of Life Sciences, University of Trieste, Trieste, Italy. aperin@gmail.com. 4. Neurosurgery Department, Fondazione IRCCS Istituto Neurologico Nazionale "C. Besta", Milan, Italy. 5. Besta NeuroSim Center, Fondazione IRCCS Istituto Neurologico Nazionale "C. Besta", Milan, Italy. 6. Neurosurgery Department, Ospedale SS. Antonio e Biagio e C. Arrigo, Alessandria, Italy. 7. Department of Neurological Surgery, Hôpitaux Universitaires de Genève HUG, Geneva, Switzerland. 8. Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy. 9. Department of Neurological Surgery, Johns Hopkins Medical School, Baltimore, MD, USA.
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. TRAIL REGISTRATION: ClinicalTrials.gov NCT03503487.
RCT Entities:
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. TRAIL REGISTRATION: ClinicalTrials.gov NCT03503487.
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