Effects of Zazen Meditation in Patients With Acute Myocardial Infarction - Randomized Clinical Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital de Clinicas de Porto Alegre

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Zazen Meditation

    Behavioral

    The 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

44 Participants
are divided into 2 treatment groups
Group A: Meditation InterventionActive comparator 1 intervention
Group B: Documentary ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
up to 12 weeks

Secondary outcomes

1

Assessment of Quality of Life through the Quality of Life and Health Questionnaire

Quality of Life and Health

Time frame
up to 12 weeks
2

Assessment of Spirituality through the Spirituality, Religiosity, and Personal Beliefs

Questionnaire

Time frame
up to 12 weeks
3

Blood Tests

Ultra-sensitive C-reactive protein and cortisol.

Time frame
up to 12 weeks
4

Echocardiography

Ejection Fraction

Time frame
up to 12 weeks

Other outcomes

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