Scalia Gianluca, Priola Stefano Maria, Ranganathan Sruthi, Venkataram Tejas, Orestano Valeria, Marrone Salvatore, Chaurasia Bipin, Maugeri Rosario, Iacopino Domenico Gerardo, Strigari Lidia, Salvati Maurizio, Umana Giuseppe Emmanuele
Neurosurgery Unit, Department of Head and Neck Sugery, Garibaldi Hospital, Catania, Italy.
Department of Neurosurgery, Health Sciences North, Northern Ontario School of Medicine, Sudbury, Ontario, Canada.
Surg Neurol Int. 2024 Mar 15;15:88. doi: 10.25259/SNI_1021_2023. eCollection 2024.
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.
知情同意是现代医学的一个关键方面，但由于所涉及信息的复杂性，它可能具有挑战性。混合现实（MR）已成为一种有前景的改善沟通的技术。然而，关于MR对医疗知情同意影响的全面研究尚缺。拟议的研究方案为开展未来调查以及制定基于MR的方案奠定了坚实基础，这些方案可增强患者在决策过程中的理解和参与度。
本研究将采用随机对照试验设计。定义两个组：将MR辅助知情同意（MRaIC）作为试验组，将传统知情同意（CIC）作为对照组，每组52例患者。该方案包括使用问卷来分析患者的焦虑水平以及对即将进行的医疗程序的认知，以研究在医疗程序前MRaIC与CIC的影响。
该研究将评估MR对患者信息理解、获取知情同意过程中的参与度、情绪反应和同意决定的影响。将解决伦理问题。
本研究方案提供了一种全面的方法来调查MR对医疗知情同意的影响。研究结果可能有助于更好地理解MR对信息理解、获取知情同意过程中的参与度、心理体验、同意决定和伦理考量的影响。MR技术的整合有可能加强手术沟通实践并改善知情同意过程。
