Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06562478

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

Led by Hospital de Clinicas de Porto Alegre · Updated on 2024-08-20

44

Participants Needed

1

Research Sites

129 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Recent acute myocardial infarction
  • Both sexes
  • Older than 18 years
  • Availability to attend the hospital at least twice a week during the study period
  • Agree to the study and sign the Free and Informed Consent Form
Not Eligible

You will not qualify if you...

  • Unstable angina
  • Extensive residual myocardial ischemia (at rest or on exertion)
  • Inadequate blood pressure response during exercise
  • Congestive heart failure class III or IV
  • Severe lung disease
  • Difficulty or inability to walk
  • Pacemaker
  • Participation in other clinical trials

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil, 90035-903

Actively Recruiting

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Research Team

R

Rosane M Nery, PhD

CONTACT

S

Sabrina Rodrigues da Silva, Ms

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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