Informed consent through 3D virtual reality: a randomized clinical trial.
Acta Neurochir (Wien)
; 163(2): 301-308, 2021 02.
Article
en En
| MEDLINE
| ID: mdl-32242272
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 111 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.Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Relaciones Médico-Paciente
/
Craneotomía
/
Imagenología Tridimensional
/
Realidad Virtual
/
Consentimiento Informado
Tipo de estudio:
Clinical_trials
/
Observational_studies
Límite:
Adult
/
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
Acta Neurochir (Wien)
Año:
2021
Tipo del documento:
Article
País de afiliación:
Italia