1. Informed consent through 3D virtual reality: a randomized clinical trial
- Author
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Torstein R. Meling, Roberta Ayadi, Enrico Gambatesa, Hagit Silberberg, Donatella Sgubin, Francesco DiMeco, Alessandro Perin, Nicole Irene Riker, Tommaso Francesco Galbiati, and Eleonora F. Orena
- Subjects
Adult ,Male ,medicine.medical_specialty ,Surgical planning ,Virtual reality ,030218 nuclear medicine & medical imaging ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Imaging, Three-Dimensional ,Randomized controlled trial ,law ,Informed consent ,medicine ,Humans ,Prospective Studies ,Physician-Patient Relations ,Informed Consent ,medicine.diagnostic_test ,business.industry ,Brain Neoplasms ,Communication ,Malpractice ,Virtual Reality ,Interventional radiology ,Middle Aged ,ddc:616.8 ,3. Good health ,Clinical trial ,Comprehension ,Physical therapy ,Anxiety ,Surgery ,Female ,Neurology (clinical) ,Neurosurgery ,medicine.symptom ,business ,030217 neurology & neurosurgery ,Craniotomy - Abstract
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. 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. 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
- Published
- 2020