Assessing the impact of mixed reality-assisted informed consent: A study protocol

Author:

Scalia Gianluca1,Priola Stefano Maria2,Ranganathan Sruthi3,Venkataram Tejas4,Orestano Valeria5,Marrone Salvatore6,Chaurasia Bipin7,Maugeri Rosario6,Iacopino Domenico Gerardo6,Strigari Lidia8,Salvati Maurizio9,Umana Giuseppe Emmanuele4

Affiliation:

1. Neurosurgery Unit, Department of Head and Neck Sugery, Garibaldi Hospital, Catania, Italy,

2. Department of Neurosurgery, Health Sciences North, Northern Ontario School of Medicine, Sudbury, Ontario, Canada,

3. Department of Medicine, University of Cambridge, Cambridge CB2 OQQ, United Kingdom,

4. Department of Neurosurgery, Trauma Center, Gamma Knife Center, Cannizzaro Hospital, Catania, Italy

5. Psychology Center Orestano-Pittera, “l’Intreccio” Association, San Giovanni la Punta (CT), Italy

6. Neurosurgical Clinic, AOUP “Paolo Giaccone”, Post Graduate Residency Program in Neurologic Surgery, Department of Biomedicine Neurosciences and Advanced Diagnostics, School of Medicine, University of Palermo, Palermo, Italy,

7. Department of Neurosurgery, Neurosurgery Clinic, Birgunj, Nepal,

8. Department of Medical Physics, University Hospital of Bologna, Bologna, Italy

9. Department of Neurosurgery, Policlinico “Tor Vergata”, University of Rome “Tor Vergata”, Rome, Italy.

Abstract

Background: Informed consent is a crucial aspect of modern medicine, but it can be challenging due to the complexity of the information involved. Mixed reality (MR) has emerged as a promising technology to improve communication. However, there is a lack of comprehensive research on the impact of MR on medical informed consent. The proposed research protocol provides a solid foundation for conducting future investigations and developing MR-based protocols that can enhance patients’ understanding and engagement in the decision-making process. Methods: This study will employ a randomized controlled trial design. Two arms will be defined: MR-assisted informed consent (MRaIC) as the experimental arm and conventional informed consent (CIC) as the control arm consent, with 52 patients in each group. The protocol includes the use of questionnaires to analyze the anxiety levels and the awareness of the procedure that the patient is going to perform to study the impact of MRaIC versus CIC before medical procedures. Results: The study will evaluate the impact of MR on patients’ information comprehension, engagement during the process of obtaining informed consent, emotional reactions, and consent decisions. Ethical concerns will be addressed. Conclusion: This study protocol provides a comprehensive approach to investigate the impact of MR on medical informed consent. The findings may contribute to a better understanding of the effects of MR on information comprehension, engagement during the process of obtaining informed consent, psychological experience, consent decisions, and ethical considerations. The integration of MR technology has the potential to enhance surgical communication practices and improve the informed consent process.

Publisher

Scientific Scholar

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