Study protocol
cognitive or visual impairments, tumor
PATHOLOGY, TUMOR, BRAIN TUMOR
The study was performed in accordance with the ethical standards of the Declaration of Helsinki 1964. The ethics committee of Charité – Universitätsmedizin Berlin approved the present randomized prospective study (EA2/019/18). The study is registered in the German Clinical Trials Register (DRKS00014930). Informed consent was obtained from all individual participants included in the study.Patients who were scheduled for a brain tumor surgery at our department between June 2018 and January 2019 were screened for this study. Patients with impending brain tumor surgery were included regardless of tumor type, location, or prior treatments. The primary exclusion criteria were cognitive or visual impairments. Patients’ capacity to give consent was critically assessed by the physician who conducted the routine consent interview, independent of the study. Only patients capable of signing their own consent in routine clinical practice were considered for this study. All eligible participants were first tested for stereopsis with the Frisby Pocket Stereotest™. All patients gave their surgical informed consent to a medical doctor from our department after being informed about the procedure in a conventional way prior to the randomization. Then, the participants were randomized into group A without any further interventions or group B with the additional stereoscopic MRI visualization of their own pathology including a second explanation of the planned surgical intervention by the same physician who had performed the routine consent (Fig. Flowchart of the study design. Group A received the surgical informed consent in a conventional manner, while group B received an additional stereoscopic visualization with a second consent conversation. Created with BioRender.com