Actively Recruiting
Effects of Zazen Meditation on Physiological and Psychological Aspects 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
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of Zazen meditation on heart rate variability in patients who have recently experienced acute myocardial infarction, a leading cause of death in Brazil. This randomized clinical trial aims to explore how meditation might impact physiological factors related to stress and heart function to support rehabilitation after a heart attack. The study will assess both acute effects during meditation sessions and chronic effects over a 12-week period. Participants will be randomly assigned to either a meditation group practicing Zazen meditation or a control group watching neutral documentaries. Meditation sessions increase from 5 to 15 minutes early on, with heart rate variability measured before and after sessions using a Polar H10 heart rate monitor and mobile app. Both groups attend sessions twice a week for three months, totaling 24 sessions. The study includes initial and final assessments to evaluate changes over time. During the study, participants will undergo various evaluations including heart rate variability measurements, quality of life and spirituality questionnaires, blood tests, echocardiography, and a six-minute walk test. Researchers will monitor acute changes during the third session and chronic changes after 12 weeks. Safety and comfort are monitored through participant feedback after sessions. The total duration of involvement is approximately 12 weeks, with all data collected to understand meditation's impact on heart health after myocardial infarction.
CONDITIONS
Brief Title
Effects of Zazen Meditation in Patients With Acute Myocardial Infarction - Randomized Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Recent acute myocardial infarction
- Both sexes
- Older than 18 years
- Available to attend hospital sessions at least twice a week during the study
- Agree to participate and sign the Free and Informed Consent Form
You will not qualify if you...
- Unstable angina
- Extensive residual myocardial ischemia at rest or during exercise
- Inadequate blood pressure response during exercise
- Congestive heart failure class III or IV
- Severe lung disease
- Difficulty or inability to walk
- Pacemaker implanted
- Participation in other clinical trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants attend meditation or documentary sessions twice a week for 3 months, totaling 24 sessions. During the third session, heart rate variability will be measured before and after the session to assess acute effects. After each session, participants may share any comfort or discomfort experienced during the intervention.
Twice-weekly sessions for 12 weeks (24 sessions total)
Duration - Assessment at the end of 12 weeks
After completing 24 sessions, participants repeat initial assessments including questionnaires, resting heart rate variability, 6-minute walk test, and blood collection to evaluate chronic effects of meditation practice.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Actively Recruiting
Research Team
R
Rosane M Nery, PhD
S
Sabrina Rodrigues da Silva, Ms
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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