About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Recent acute myocardial infarction
Both sexes
>18 years old
Availability to attend the hospital at least twice a week during the study period
Disqualifiers
Unstable angina
Extensive residual myocardial ischemia (at rest or on exertion)
Inadequate blood pressure response during exercise
Congestive heart failure class III or IV
Trial design
Parallel
Treatments tested in this trial
Zazen Meditation
BehavioralThe sessions will last a maximum of 40 minutes in total, comprising 10 minutes of introduction with general practice instructions, followed by 15 minutes of Zazen meditation practice. The final 15 minutes will be allocated for participants to provide feedback on the session.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Assessment of Quality of Life through the Quality of Life and Health Questionnaire
Quality of Life and Health
Assessment of Spirituality through the Spirituality, Religiosity, and Personal Beliefs
Questionnaire
Blood Tests
Ultra-sensitive C-reactive protein and cortisol.
Echocardiography
Ejection Fraction
Sponsors and contacts
Click on the lead sponsor to view all of their trials.