Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Dec 6, 2022
Open Peer Review Period: Dec 6, 2022 - Dec 22, 2022
Date Accepted: Apr 13, 2023
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Effectiveness of Brain-computer Interface Based, App-Delivered Mindfulness Meditation in Radiofrequency Catheter Ablation for Atrial Fibrillation Patients : Randomized Controlled Trial
ABSTRACT
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. Clinical Trial: ClinicalTrials.gov NCT05306015; https://clinicaltrials.gov/ct2/show/NCT05306015
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.