Effects of Zazen Meditation in Patients With Acute Myocardial Infarction - Randomized Clinical Trial
NCT Number: NCT06562478
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Rate Variability|Acute Myocardial Infarction
Interventions: BEHAVIORAL: Zazen Meditation
Sponsor: Hospital de Clinicas de Porto Alegre
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-02-05
Completion Date: 2026-07-31
Locations: Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande Do Sul, 90035-903, Brazil

Summary:
Introduction: Coronary Artery Disease (CAD) remains the leading cause of death in Brazil, with literature indicating that in patients post-acute myocardial infarction, reduced Heart Rate Variability (HRV) has been established as a risk factor. One of the studied practices to aid in rehabilitation is meditation, believed to alter physiological aspects related to stress such as respiratory rate, oxygen consumption, carbon dioxide production, and systolic blood pressure, suggesting a better sympathetic-vagal balance. Objective: To assess the effects of Zazen meditation practice on heart rate variability in patients with recent acute and chronic myocardial infarction. Methodology: Randomized Clinical Trial. Chronic assessments will include: HRV with Polar H10 heart rate monitor, Quality of Life assessment with SF36 Quality of Life and Health questionnaire, Spiritual assessment with WHOQOL SR Spirituality, Religiosity, and Personal Beliefs questionnaire, Biochemical Parameters with ultra-sensitive PCR and cortisol, Ventricular Ejection Fraction (VEF), and 6-minute Walk Test (6MWT). Acute assessments will include: HRV with Polar H10 heart rate monitor, before and after a meditation session, in time and frequency domains. Sample size calculation was performed using Winpepi software version 11.43, with a power of 80% and significance level of 5%, determining a sample of 44 individuals. For intra-group differences analysis, ANOVA for repeated measures and/or its non-parametric counterpart, Friedman Test, will be used. For proportion analysis and comparison, Chi-square Test will be used. Expected Results: It is expected that the findings will contribute to a better understanding of the potential benefits that a meditation intervention may bring to patients who have experienced acute myocardial infarction.

Primary Outcome Measures: Heart Rate Variability, Assessed using the Polar H10 heart rate monitor, before and after a meditation session to evaluate acute effects, and before and after 24 sessions to evaluate chronic effects., up to 12 weeks
Secondary Outcome Measures: Assessment of Quality of Life through the Quality of Life and Health Questionnaire, Quality of Life and Health, up to 12 weeks|Assessment of Spirituality through the Spirituality, Religiosity, and Personal Beliefs, Questionnaire, up to 12 weeks|Blood Tests, Ultra-sensitive C-reactive protein and cortisol., up to 12 weeks|Echocardiography, Ejection Fraction, up to 12 weeks|Six-Minute Walk Test, Functional Capacity, up to 12 weeks