RCT Abstract - Effect of Personalized Informed Consent with Individual Data-based Bronchoscopy Simulator on Peri-procedure Anxiety

Background： Informed consent is mandatory but detailed risk information increases preoperative anxiety among patients undergoing bronchoscopy. Textual information is difficult for patients to understand the bronchoscopy procedure, emphasizing the need for visual informed consent. A novel bronchoscopy simulator based on individual patient chest-CT data has been developed to visualize the bronchoscopy procedure. we aimed to evaluated the impact of this simulator on patient anxiety. Methods： In this prospective, multicenter, randomized controlled trial, we assessed preoperative anxiety using the modified Amsterdam Preoperative Anxiety and Information Scale (APAIS) and a 100mm Anxiety Visual Analogue Scale (VAS) before and after obtaining informed consent. Results： The study included 110 patients undergoing elective local anaesthesia for bronchoscopy. Baseline demographic, clinical and anxiety measures were similar between the two groups. After using the personalised data-based bronchoscopy simulator, patients showed a significant reduction in anxiety as measured by APAIS (mean -5.29 vs 2.13) and VAS (mean -8.67 vs 8.47). In addition, anxiety specifically related to the surgical procedure decreased significantly, with a mean difference of -3 points (p<0.001). <bold>Conclusion:</bold> Visual informed consent using personalized data-driven bronchoscopy simulator was effective in significantly reducing patient anxiety. <fig><object-id>erj;64/suppl_68/RCT997/F1</object-id><object-id>F1</object-id><object-id>F1</object-id><graphic></graphic></fig>