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

Impact of Stress reduction, meditation and mindfulness program in perceived stress of patients with chronic Heart failure: randomized clinical trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7pzcyk
Enrollment
Unknown
Registered
2020-04-20
Start date
2019-05-31
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure

Interventions

The intervention consists of a Stress Reduction, Meditation and Mindfulness Program where 8 consecutive weekly meetings lasting 2 hours are held. Patients receive training in coping tools such as resi
Behavioural
F02.463.551
E02.190.525.374

Sponsors

Universidade Federal Fluminense
Lead Sponsor
Instituto Nacional de Cardiologia
Collaborator

Eligibility

Age
18 Years to 85 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Brazil

Contacts

Public ContactVaisnava Cavalcante

Universidade Federal Fluminense

vaisnavancavalcante@gmail.com+55-021-997989015

Outcome results

None listed

Source: REBEC (via WHO ICTRP)