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

Informed consent Mixed reality Patient engagement Surgical interventions Surgical outcomes

Journal

Surgical neurology international
ISSN: 2229-5097
Titre abrégé: Surg Neurol Int
Pays: United States
ID NLM: 101535836

Informations de publication

Date de publication:
2024
Historique:
received: 26 12 2023
accepted: 20 02 2024
medline: 17 4 2024
pubmed: 17 4 2024
entrez: 17 4 2024
Statut: epublish

Résumé

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. 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. 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. 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.

Sections du résumé

Background UNASSIGNED
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 UNASSIGNED
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 UNASSIGNED
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 UNASSIGNED
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.

Identifiants

pubmed: 38628537
doi: 10.25259/SNI_1021_2023
pii: 10.25259/SNI_1021_2023
pmc: PMC11021117
doi:

Types de publication

Journal Article

Langues

eng

Pagination

88

Informations de copyright

Copyright: © 2024 Surgical Neurology International.

Déclaration de conflit d'intérêts

There are no conflicts of interest.

Auteurs

Gianluca Scalia (G)

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

Stefano Maria Priola (SM)

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

Sruthi Ranganathan (S)

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

Tejas Venkataram (T)

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

Valeria Orestano (V)

Psychology Center Orestano-Pittera, "l'Intreccio" Association, San Giovanni la Punta (CT), Italy.

Salvatore Marrone (S)

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.

Bipin Chaurasia (B)

Department of Neurosurgery, Neurosurgery Clinic, Birgunj, Nepal.

Rosario Maugeri (R)

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.

Domenico Gerardo Iacopino (DG)

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.

Lidia Strigari (L)

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

Maurizio Salvati (M)

Department of Neurosurgery, Policlinico "Tor Vergata", University of Rome "Tor Vergata", Rome, Italy.

Giuseppe Emmanuele Umana (GE)

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

Classifications MeSH