Assessing the Impact of Mixed Reality-assisted Informed Consent: A Study Protocol

Overview

Journal Surg Neurol Int

Specialty Neurology

Date 2024 Apr 17

PMID 38628537

Authors

Gianluca Scalia

Stefano Maria Priola

Sruthi Ranganathan

Tejas Venkataram

Valeria Orestano

Salvatore Marrone

Bipin Chaurasia

Rosario Maugeri

Domenico Gerardo Iacopino

Lidia Strigari

Maurizio Salvati

Giuseppe Emmanuele Umana

Affiliations

Soon will be listed here.

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.

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References

Aliwi I, Schot V, Carrabba M, Duong P, Shievano S, Caputo M . The Role of Immersive Virtual Reality and Augmented Reality in Medical Communication: A Scoping Review. J Patient Exp. 2023; 10:23743735231171562. PMC: 10333997. DOI: 10.1177/23743735231171562. View

Wagner D, Bear M . Patient satisfaction with nursing care: a concept analysis within a nursing framework. J Adv Nurs. 2008; 65(3):692-701. DOI: 10.1111/j.1365-2648.2008.04866.x. View

Krishnamurti T, Argo N . A Patient-Centered Approach to Informed Consent: Results from a Survey and Randomized Trial. Med Decis Making. 2016; 36(6):726-40. DOI: 10.1177/0272989X16636844. View

Mishra R, Narayanan M, Umana G, Montemurro N, Chaurasia B, Deora H . Virtual Reality in Neurosurgery: Beyond Neurosurgical Planning. Int J Environ Res Public Health. 2022; 19(3). PMC: 8835688. DOI: 10.3390/ijerph19031719. View

Gabay G, Bokek-Cohen Y . What do patients want? Surgical informed-consent and patient-centered care - An augmented model of information disclosure. Bioethics. 2019; 34(5):467-477. DOI: 10.1111/bioe.12703. View

Grant S . Informed Consent-We Can and Should Do Better. JAMA Netw Open. 2021; 4(4):e2110848. DOI: 10.1001/jamanetworkopen.2021.10848. View

Scott H, Griffin C, Coggins W, Elberson B, Abdeldayem M, Virmani T . Virtual Reality in the Neurosciences: Current Practice and Future Directions. Front Surg. 2022; 8:807195. PMC: 8894248. DOI: 10.3389/fsurg.2021.807195. View

Yeung A, Tosevska A, Klager E, Eibensteiner F, Laxar D, Stoyanov J . Virtual and Augmented Reality Applications in Medicine: Analysis of the Scientific Literature. J Med Internet Res. 2021; 23(2):e25499. PMC: 7904394. DOI: 10.2196/25499. View

Cai E, Gao Y, Ngiam K, Lim T . Mixed Reality Intraoperative Navigation in Craniomaxillofacial Surgery. Plast Reconstr Surg. 2021; 148(4):686e-688e. DOI: 10.1097/PRS.0000000000008375. View

10.

McCloskey K, Turlip R, Ahmad H, Ghenbot Y, Chauhan D, Yoon J . Virtual and Augmented Reality in Spine Surgery: A Systematic Review. World Neurosurg. 2023; 173:96-107. DOI: 10.1016/j.wneu.2023.02.068. View

11.

Brown R, Bylund C, Siminoff L, Slovin S . Seeking informed consent to Phase I cancer clinical trials: identifying oncologists' communication strategies. Psychooncology. 2010; 20(4):361-8. DOI: 10.1002/pon.1748. View

12.

Jain S, Gao Y, Yeo T, Ngiam K . Use of Mixed Reality in Neuro-Oncology: A Single Centre Experience. Life (Basel). 2023; 13(2). PMC: 9965132. DOI: 10.3390/life13020398. View

13.

Yu Q, Pun J . Promoting Patient Engagement in Medical Informed Consent - A Qualitative Study of Chinese Doctors' Communication Strategies. Health Commun. 2021; 38(1):71-79. DOI: 10.1080/10410236.2021.1932287. View

14.

Park J, Son W, Park K, Kang D, Lee J, Oh C . Educational and interactive informed consent process for treatment of unruptured intracranial aneurysms. J Neurosurg. 2016; 126(3):825-830. DOI: 10.3171/2016.2.JNS151830. View

15.

Perin A, Galbiati T, Ayadi R, Gambatesa E, Orena E, Riker N . Informed consent through 3D virtual reality: a randomized clinical trial. Acta Neurochir (Wien). 2020; 163(2):301-308. DOI: 10.1007/s00701-020-04303-y. View

16.

Balci D, Kirimker E, Raptis D, Gao Y, Kow A . Uses of a dedicated 3D reconstruction software with augmented and mixed reality in planning and performing advanced liver surgery and living donor liver transplantation (with videos). Hepatobiliary Pancreat Dis Int. 2022; 21(5):455-461. DOI: 10.1016/j.hbpd.2022.09.001. View

17.

Hertzsprung N, Krantchev K, Picht T, Roethe A, Rubarth K, Fuellhase J . Personalized surgical informed consent with stereoscopic visualization in neurosurgery-real benefit for the patient or unnecessary gimmick?. Acta Neurochir (Wien). 2023; 165(4):1087-1098. PMC: 10068664. DOI: 10.1007/s00701-023-05512-x. View

18.

House P, Pelzl S, Furrer S, Lanz M, Simova O, Voges B . Use of the mixed reality tool "VSI Patient Education" for more comprehensible and imaginable patient educations before epilepsy surgery and stereotactic implantation of DBS or stereo-EEG electrodes. Epilepsy Res. 2019; 159:106247. DOI: 10.1016/j.eplepsyres.2019.106247. View

19.

Umana G, Scalia G, Yagmurlu K, Mineo R, Di Bella S, Giunta M . Multimodal Simulation of a Novel Device for a Safe and Effective External Ventricular Drain Placement. Front Neurosci. 2021; 15:690705. PMC: 8236630. DOI: 10.3389/fnins.2021.690705. View

20.

Singhal I, Kaur G, Neefs D, Pathak A . A Literature Review of the Future of Oral Medicine and Radiology, Oral Pathology, and Oral Surgery in the Hands of Technology. Cureus. 2023; 15(9):e45804. PMC: 10591112. DOI: 10.7759/cureus.45804. View