The Effect of a Smartphone and Wearable-based Stress Management Application on Cardiac Symptoms in Women with Coronary Artery Spasms: a Multicenter, Single-Arm, One-way Crossover Study (Preprint)

BACKGROUND Mental stress is a well-known trigger of cardiac symptoms in patients with coronary artery spasms. Hence, stress management is recommended beyond medical therapy. However, specific programs for patients with coronary spasms are lacking. We collaborated with patients to develop a smartphone-based application as a tailored solution. The application provides biofeedback based on HRV-driven stress level estimations. OBJECTIVE Our study aimed to evaluate the effect of a biofeedback-driven smartphone stress management application on cardiac symptoms in women with coronary vasospasms. METHODS We enrolled 117 women aged 18-70 diagnosed with coronary vasospasms, as confirmed by a gold standard coronary function test. A multicenter single sequence 2-period cross-over study was performed, consisting of a four-week control period followed by four weeks using the Wavy intervention app. The intervention comprised suggested breathing-based exercises if measured stress levels were too high. The primary outcome was the Seattle Angina Questionnaire summary score; secondary outcomes included quality of life using the SF-36, stress by means of the PSS-10. Additionally, the user experience and the impact of the breathing exercise on HRV were evaluated. RESULTS Within the 102 patients that finished the study, no significant improvements were observed in the SAQ-SS scores following the intervention period, with control group values at 50.4 ± 15.4 SD and intervention group values at 50.9 ± 15.0 SD. Similarly, no differences were found in the quality-of-life and perceived stress m hebben tezamen met patiënten en een ergotherapeut nieuwe functionaliteiten etrics. However, the 1,236 breathing relaxation exercises performed during the study led to a significant improvement in heart rate variability (HRV), as indicated by a median (IQR) RMSSD increase from 18.59 ms (8.38–36.58) before the exercises to 34.93 ms (24.19–50.64) after the exercises (Z = -13.72, p < 0.001). Furthermore, two-thirds of participants indicated they would use a more refined version in the future. CONCLUSIONS A four-week intervention using the Wavy application did not significantly alleviate anginal symptoms in female patients with coronary vasospasms. However, the breathing exercises demonstrated a notable improvement in HRV values, suggesting a reduction in stress levels. Patient feedback indicated broad support for the application and its wearable-based functionality, emphasizing the need for substantial refinements. Future development should incorporate patient perspectives to optimize the application as a comprehensive lifestyle management tool. CLINICALTRIAL ClinicalTrials.gov Identifier: NCT06171893. Assessing the Effect of the 'Wavy' Application, on Stress and Burden of Disease in Women With INOCA, available at https://classic.clinicaltrials.gov/ct2/show/NCT06171893.