Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562478
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-04-26
Brief Title:
Effects of Zazen Meditation in Patients With Acute Myocardial Infarction - Randomized Clinical Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Zazen Meditation on Physiological and Psychological Aspects in Patients With Acute Myocardial Infarction - Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 1143 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 andor 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 ie 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 ie 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
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 ie 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None