[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559311":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":38,"responsibleParty":56,"collaborators":24,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":24,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":24,"enrollmentInfo":67,"targetDuration":24,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":40,"whyStopped":24,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Hospital de Clinicas de Porto Alegre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Behavioral: Zazen Meditation",{"label":15,"type":10,"description":16,"interventionNames":17},"Documentary Control","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.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"BEHAVIORAL","Zazen Meditation","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.",[15,9],null,[26],{"name":27,"affiliation":28,"role":29},"Rosane M Nery, PhD","Hospital de Clínicas de Porto Alegre","PRINCIPAL_INVESTIGATOR",[31,35],{"name":27,"role":32,"phone":33,"phoneExt":24,"email":34},"CONTACT","+555133597634","rosane.nery@gmail.com",{"name":36,"role":32,"phone":33,"phoneExt":24,"email":37},"Sabrina Rodrigues da Silva, Ms","sabrina.ed.fis@gmail.com",[39],{"facility":28,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Porto Alegre","Rio Grande do Sul","90035-903","Brazil","BR",{"type":47,"coordinates":48},"Point",[49,50],-51.23019,-30.03283,{"lat":50,"lon":49},[53],{"name":54,"role":32,"phone":55,"phoneExt":24,"email":34},"Rosane M. Nery, PhD","0555133597634",{"type":57,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100559311","effects-of-zazen-meditation-in-patients-with-acute-myocardial-infarction---randomized-clinical-trial-100559311",false,"NCT06562478","Effects of Zazen Meditation in Patients With Acute Myocardial Infarction - Randomized Clinical Trial","Effects of Zazen Meditation on Physiological and Psychological Aspects in Patients With Acute Myocardial Infarction - Randomized Clinical Trial","Inclusion Criteria:\n\n* Recent acute myocardial infarction\n* Both sexes\n* \\>18 years old\n* Availability to attend the hospital at least twice a week during the study period\n* Agree to the study and sign the Free and Informed Consent Form.\n\nExclusion Criteria:\n\n* Unstable angina\n* Extensive residual myocardial ischemia (at rest or on exertion)\n* Inadequate blood pressure response during exercise\n* Congestive heart failure class III or IV\n* Severe lung disease\n* Difficulty or inability to walk\n* Pacemaker\n* Participation in other clinical trials","ALL","18 Years",{"count":68,"type":69},44,"ESTIMATED","INTERVENTIONAL",[72],"NA","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\u002For 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.",[75,76],"Heart Rate Variability","Acute Myocardial Infarction",[78,79],"Myocardial Infarction","heart rate variability","2024-08-16",{"date":82,"type":83},"2024-08-20","ACTUAL",{"date":85,"type":83},"2024-02-05",{"date":87,"type":69},"2026-07-31",{"name":5,"class":6},1]