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Informed consent through 3D virtual reality: a randomized clinical trial

  • Original Article - Neurosurgery general
  • Published:
Acta Neurochirurgica Aims and scope Submit manuscript

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 1:1:1 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

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Acknowledgments

We deeply thank Ms Nina Ravelli for her generous and continuous support to the Besta NeuroSim Center.

Funding

The study was partly funded by the European Commission through the FP7-Health Research Project TheraGlio (Grant Agreement ID: 602923); Dr Hagit Silberberg was paid by Surgical Theater while conducting this study.

Author information

Author notes

  1. Alessandro Perin and Tommaso Francesco Galbiati contributed equally to this work.

Authors and Affiliations

  1. Neurosurgery Department, Fondazione IRCCS Istituto Neurologico Nazionale “C. Besta”, Milan, Italy

    Alessandro Perin, Tommaso Francesco Galbiati, Roberta Ayadi, Enrico Gambatesa, Eleonora Francesca Orena, Nicole Irene Riker & Francesco DiMeco

  2. Besta NeuroSim Center, Fondazione IRCCS Istituto Neurologico Nazionale “C. Besta”, Milan, Italy

    Alessandro Perin, Tommaso Francesco Galbiati, Roberta Ayadi, Enrico Gambatesa, Eleonora Francesca Orena, Nicole Irene Riker, Hagit Silberberg, Torstein Ragnar Meling & Francesco DiMeco

  3. Department of Life Sciences, University of Trieste, Trieste, Italy

    Alessandro Perin

  4. Neurosurgery Department, Ospedale SS. Antonio e Biagio e C. Arrigo, Alessandria, Italy

    Donatella Sgubin

  5. Department of Neurological Surgery, Hôpitaux Universitaires de Genève HUG, Geneva, Switzerland

    Torstein Ragnar Meling

  6. Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy

    Francesco DiMeco

  7. Department of Neurological Surgery, Johns Hopkins Medical School, Baltimore, MD, USA

    Francesco DiMeco

Authors
  1. Alessandro Perin
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  2. Tommaso Francesco Galbiati
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  3. Roberta Ayadi
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  4. Enrico Gambatesa
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  5. Eleonora Francesca Orena
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  6. Nicole Irene Riker
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  7. Hagit Silberberg
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  8. Donatella Sgubin
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  9. Torstein Ragnar Meling
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  10. Francesco DiMeco
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Corresponding author

Correspondence to Alessandro Perin.

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Conflict of interest

Hagit Silberberg worked at Surgical Theater.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Perin, A., Galbiati, T.F., Ayadi, R. et al. Informed consent through 3D virtual reality: a randomized clinical trial. Acta Neurochir 163, 301–308 (2021). https://doi.org/10.1007/s00701-020-04303-y

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  • DOI: https://doi.org/10.1007/s00701-020-04303-y

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