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

中文翻译：

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通过3D虚拟现实获得知情同意：一项随机临床试验

摘要

背景

知情同意是决定性的时刻，应使患者了解自己的病情，正在接受的程序以及可能产生的后果。这个过程应该在不增加患者焦虑的情况下建立信任并增强信心。新的沉浸式3D成像技术可以充当促进这一努力的工具。

方法

在一项前瞻性，单中心，随机对照临床试验中（SPLICE研究：外科手术计划和知情同意研究； ClinicalTrials.gov NCT03503487），共有40名接受颅内肿瘤手术的患者入选。在接受传统的手术知情同意后，将33例患者按1：1：1分为3组：在2个实验组中，患者接受3D浸入式知情同意并由两名不同的手术计划者进行治疗（组1和组2）；在对照组中，患者接受了传统2D放射学影像支持下的知情同意。

结果

实验组的患者赞赏这种交流经验，而他们的客观理解力更高（（平均得分（SD））：组1 82.65（6.83）；组2 77.76（10.19）），与对照组相比（57.70（12.49） ）; P  <0.001）。实验组和对照组之间的主观理解和焦虑水平没有差异。

结论

3D虚拟现实可以帮助外科医生和患者在手术前建立更好的关系；浸入式3D支持的知情同意书可以提高患者对病情的理解，而不会增加焦虑。这种新的范例可能会增强外科医生与患者之间的信任，并可能限制医疗法律行为。

足迹注册

ClinicalTrials.gov NCT03503487