Heart Rate VariabilityNCT06562478
Effects of Zazen Meditation in Patients With Acute Myocardial Infarction - Randomized Clinical Trial
A study testing Zazen Meditation in people with Heart Rate Variability and Acute Myocardial Infarction, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Rate Variability, Acute Myocardial Infarction
- What is being tested?
- Zazen Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Feb 2024to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recent acute myocardial infarction
- Both sexes
- >18 years old
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Rosane M. Nery, PhD, 0555133597634, rosane.nery@gmail.com
About this study
Official title: Effects of Zazen Meditation on Physiological and Psychological Aspects in Patients With Acute Myocardial Infarction - Randomized Clinical 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.
Read the detailed description
Chronic Study: The chronic effects of meditation practice will be evaluated at the beginning of the study and after 12 weeks of intervention. All study participants, regardless of group, will be invited to attend an initial conversation where all study procedures and assessments will be explained. Any questions will be clarified, and necessary explanations will be provided. After signing the Informed Consent Form (ICF), evaluations related to the chronic effects of meditation will be conducted, including the administration of specific questionnaires, resting HRV assessment, HRV assessment after the Stroop Test, 6-minute Walk Test (6MWT), and blood collection. Once all evaluations are completed, participants will be cleared to proceed with the study and begin the sessions.
At the end of each meditation session, participants will be invited to have tea with the researchers to report any comforts or discomforts experienced during the intervention. After completing the chronic study, i.e., after the 24 sessions, participants will repeat the same initial assessments conducted at the beginning of the study.
Acute Study: The acute study will occur simultaneously with the chronic study, as part of the Randomized Clinical Trial. Acute effects will be evaluated during the third intervention session in both groups, i.e., in the meditation and documentary sessions. On this day, participants must arrive 40 minutes before the session begins for the placement of the Polar H10 and to receive further instructions to ensure the quality of the assessment. Participants will remain at rest for ten minutes while being monitored, and after the protocol is completed, HRV will be recorded for the 5 minutes before the start of the session and for the 5 minutes after the session ends.
- Being tested
- Zazen Meditation
- Keywords
- Myocardial Infarction, heart rate variability
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zazen MeditationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Meditation Intervention | Active comparator | Aspects of Zazen will be addressed. In the first session, the practice will be conducted for a duration of 5 minutes. In the second session, the duration will be extended to 10 minutes, aiming to provide adaptation for the participants. In the third session, the practice will last for 15 minutes, during which heart rate variability will be measured using the Polar H10 chest strap and the Elite HRV mobile app, both before and after the practice, to assess acute effects. At the end of the 24 sessions, the chronic effects of the practices will be evaluated in the same manner. Receives: Behavioral: Zazen Meditation |
| Documentary Control | Active comparator | Neutral documentary on quality of life, for 30 minutes twice a week. Both groups will undergo intervention twice a week for 3 months, totaling 24 sessions. In the third session, heart rate variability assessment will be conducted to observe the acute effects of the method. Receives: Behavioral: Zazen Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12 weeks
Secondary outcomes (5)
Assessment of Quality of Life through the Quality of Life and Health Questionnaire
Quality of Life and Health
Measured: up to 12 weeks
Assessment of Spirituality through the Spirituality, Religiosity, and Personal Beliefs
Questionnaire
Measured: up to 12 weeks
Blood Tests
Ultra-sensitive C-reactive protein and cortisol.
Measured: up to 12 weeks
Echocardiography
Ejection Fraction
Measured: up to 12 weeks
Six-Minute Walk Test
Functional Capacity
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start5 Feb 2024
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Rate VariabilityStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosane M Nery, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562478
- Sponsor's protocol ID
- 2019-0506
- Status last verified
- Aug 2024
- First submitted
- 26 Apr 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Zazen Meditation on Physiological and Psychological Aspects in Patients With Acute Myocardial Infarction - Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06562478
- Acronym / sponsor ID
- 2019-0506
- Keywords
- Myocardial Infarction, heart rate variability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic Study: The chronic effects of meditation practice will be evaluated at the beginning of the study and after 12 weeks of intervention. All study participants, regardless of group, will be invited to attend an initial conversation where all study procedures and assessments will be explained. Any questions will be clarified, and necessary explanations will be provided. After signing the Informed Consent Form (ICF), evaluations related to the chronic effects of meditation will be conducted, including the administration of specific questionnaires, resting HRV assessment, HRV assessment after the Stroop Test, 6-minute Walk Test (6MWT), and blood collection. Once all evaluations are completed, participants will be cleared to proceed with the study and begin the sessions.
At the end of each meditation session, participants will be invited to have tea with the researchers to report any comforts or discomforts experienced during the intervention. After completing the chronic study, i.e., after the 24 sessions, participants will repeat the same initial assessments conducted at the beginning of the study.
Acute Study: The acute study will occur simultaneously with the chronic study, as part of the Randomized Clinical Trial. Acute effects will be evaluated during the third intervention session in both groups, i.e., in the meditation and documentary sessions. On this day, participants must arrive 40 minutes before the session begins for the placement of the Polar H10 and to receive further instructions to ensure the quality of the assessment. Participants will remain at rest for ten minutes while being monitored, and after the protocol is completed, HRV will be recorded for the 5 minutes before the start of the session and for the 5 minutes after the session ends.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meditation Intervention | Active comparator | Behavioral: Zazen MeditationAspects of Zazen will be addressed. In the first session, the practice will be conducted for a duration of 5 minutes. In the second session, the duration will be extended to 10 minutes, aiming to provide adaptation for the participants. In the third session, the practice will last for 15 minutes, during which heart rate variability will be measured using the Polar H10 chest strap and the Elite HRV mobile app, both before and after the practice, to assess acute effects. At the end of the 24 sessions, the chronic effects of the practices will be evaluated in the same manner. |
| Documentary Control | Active comparator | Behavioral: Zazen MeditationNeutral documentary on quality of life, for 30 minutes twice a week. Both groups will undergo intervention twice a week for 3 months, totaling 24 sessions. In the third session, heart rate variability assessment will be conducted to observe the acute effects of the method. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Recent acute myocardial infarction
- Both sexes
- >18 years old
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zazen MeditationThe 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. | Behavioural | Documentary Control, Meditation Intervention |
Primary outcome
Heart Rate Variability
Time frame: up to 12 weeks
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.
5 secondary outcomes
Assessment of Quality of Life through the Quality of Life and Health Questionnaire
Time frame: up to 12 weeks
Assessment of Spirituality through the Spirituality, Religiosity, and Personal Beliefs
Time frame: up to 12 weeks
Blood Tests
Time frame: up to 12 weeks
Echocardiography
Time frame: up to 12 weeks
Six-Minute Walk Test
Time frame: up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosane M Nery, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zazen Meditation in people with Heart Rate Variability and Acute Myocardial Infarction, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rosane M Nery, PhD (+555133597634, rosane.nery@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.