Stress reduction, meditation and mindfulness program in patients with chronic Heart failure

Not Applicable

• Conditions: C10.886; Heart failure; Stress, Psychological; Sleep Wake Disorders; Depressive Disorder, Anxiety Disorders; F03.080; F03.600.300; F01.145.126.990

• Registration Number: RBR-7pzcyk
• Lead Sponsor: niversidade Federal Fluminense

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-20
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

HF NYHA class I or II; literate, owners of an audio device for listening the meditation CD; committed adhering to 8 weeks of the program; with Mini Mental score beyond 16

Exclusion Criteria

Concomitant participation in another study or therapy involving mind body or drug intervention in the last month; Recent clinical decompensation with hospitalization or changes in medication prescription for HF in the last month; Surgery or percutaneous intervention planned for the next year; Presence of acute coronary syndrome or acute myocardial infarction within the last 2 months; Clinically significant valve disease; Acute myocarditis; Musculoskeletal diseases that prevented functional tests such as the 6 minute walk test

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impact in perceived Stress (Perceived stress scale PSS-14), Anxiety (State-trace anxiety scale), Depression (Beck Depression Inventory-II) and Mindfulness (Freiburg mindfulness inventory).;Significant reduction in Stress Perception Scores by 37.3% and improvement in the score for mindfulness by 10%. Positive trends in reducing anxiety and depression but without statistical significance.

Secondary Outcome Measures

Name	Time	Method
Impact in Quality of life (Minnesota Living with Heart Failure questionnaire), sleep quality ( Pittsburgh Sleep Quality Index), functional capacity (6-minute walk test), inflammatory (IL1, IL6, TNF-alfa, RCP and ESR) and neuro-hormonal (NT-proBNP, Cortisol, Adrenaline and Noradrenaline) panels.;Significant improvement in quality of life by of 40%, in quality of sleep by 35.2%, in functional capacity by 22% and smaller increase in cortisol levels (16% vs 19%), without significant changes in the other biomarkers.