Effectiveness of Brain-computer Interface Based, App-Delivered Mindfulness Meditation in Radiofrequency Catheter Ablation for Atrial Fibrillation Patients : Randomized Controlled Trial (Preprint)

BACKGROUND Radiofrequency catheter ablation (RFCA) for atrial fibrillation (AF) patients may generate considerable physical and psychological discomfort under conscious sedation. App-based mindfulness meditation together with electroenchephalography (EEG) based brain-computer interface (BCI) shows promise to be effective and accessible adjuncts in medical practice. OBJECTIVE This study aimed to investigate the effectiveness of a BCI based mindfulness meditation app in improving AF patients’ experience in RFCA. METHODS This was a single-center randomized controlled trial. 84 eligible AF patients scheduled for RFCA were randomized 1:1 to the intervention group and control group. Both groups received a standardized RFCA procedure and conscious sedative regimen. Patients in the control group were given conventional care, while patients in the intervention group received BCI based, app-delivered mindfulness meditation from a research nurse. The primary outcomes were the changes in the numeric rating scale (NRS), State Anxiety Inventory (A-State) and Brief Fatigue Inventory (BFI) scores. Secondary outcomes were the differences in hemodynamic parameters (heart rate, blood pressure, SpO2), adverse events, patients reported pain and the amount of sedative drugs used in ablation. RESULTS BCI based, app-delivered mindfulness meditation appeared significantly lower in the mean NRS (mean 4.6, SD 1.7 vs mean 5.7, SD 2.1; P=.008) , A-State (mean 36.7, SD 5.5 vs mean 42.3, SD 7.2; P<.001) and BFI (mean 3.4, SD 2.3 vs mean 4.7, SD 2.2; P=.011) scores than conventional care. There were no statistical differences in the hemodynamic parameters, the amount of parecoxib and dexmedetomidine used in RFCA between two groups. While, the intervention group had significantly decreased fentanyl used compared with the control group (mean 273.5, SD 86.5 vs mean 330.5, SD 73.1; P=.002). The incidence of adverse events in the intervention group (5/40) was lower than that in the control group (10/40) with no statistical significant(P=.15). CONCLUSIONS The BCI based, app-delivered mindfulness meditation could effectively relieve physical and psychological discomfort, and may reduce the amount of sedative medication used in RFCA of AF. CLINICALTRIAL ClinicalTrials.gov NCT05306015; https://clinicaltrials.gov/ct2/show/NCT05306015