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NCT06562478

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

Recruiting now NA Last updated 20 August 2024
What this trial tests

NA trial testing Zazen Meditation in Heart Rate Variability in 44 participants. Currently enrolling.

Timeline
5 February 2024
Primary endpoint
31 January 2025
31 July 2026

Quick facts

Lead sponsorHospital de Clinicas de Porto Alegre
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposehealth services research
Enrollment44
Start date5 February 2024
Primary completion31 January 2025
Estimated completion31 July 2026
Sites1 location across Brazil

Drugs / interventions tested

Conditions studied

Sponsor

Hospital de Clinicas de Porto Alegre

Who can join

18 and older, any sex, with Heart Rate Variability or Acute Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Heart Rate Variability

Currently open trials in the same condition.

Other Hospital de Clinicas de Porto Alegre trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06562478.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing