Effects of a 20-Minute Mindfulness-Based Breathing Exercise on Dyspnea, Fatigue, and Sleep Quality in Patients With Heart Failure

NCT07046091 | Not Yet Recruiting

• 1 other identifier: FUGDRL-001
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

Heart failure (HF) is a chronic condition that leads to incapacity. Despite significant progress in optimizing pharmacological treatment for HF patients, the personal and social burden of this disease is still characterized by debilitating symptoms and rehospitalizations. Today, many patients with heart failure use non-pharmacological methods for managing common symptoms. Due to the increased interest in non-pharmacological methods among individuals in society, it has become essential for healthcare professionals, including nurses as part of the healthcare team, to play a role in these methods to meet the health needs of the community. One of the interventions nurses can offer for symptom management is mindfulness-based breathing exercises. In this mind-body-based practice, attention is focused on the breath, helping individuals develop awareness of their negative thoughts and emotions. The study population will consist of patients admitted to the Cardiology Department of Firat University Hospital. The sample size was determined by a power analysis, with a 0.05 margin of error, a 0.95 confidence interval, and a 0.5 effect size, representing 80% of the population, resulting in 72 patients for both the experimental and control groups. Data collection tools for the study will include a Personal Information Form, the Dyspnea-12 Scale, the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale, and the Richard-Campbell Sleep Scale. SPSS (Statistical Programme for Social Sciences) software will be used to analyze the data obtained from the study. The aim of this study is to determine the effects of a 20-minute mindfulness-based breathing exercise on dyspnea, fatigue, and sleep quality in patients with heart failure.

Conditions

Heart Failure; Heart Failure - NYHA II - IV

Keywords

heart failure; mindfulness; dsypnea; fatigue; sleep quality

Outcome Measures

Primary Outcomes (3)

• dyspnea severity

  Dyspnea Severity Measurement Tool: Dyspnea-12 Scale Time Frame: \[Measurement time, e.g., "After a 20-minute mindfulness-based breathing exercise"\] Unit of Measure: \[Unit of measure, e.g., "scores"\] Scale Title: Dyspnea-12 Scale Scale Range: \[0\] - \[12\] Interpretation: Higher scores indicate worse outcomes.

  Baseline and 6 weeks after intervention

• Fatigue Severity

  Fatigue Measurement Tool: FACIT-F Scale Time Frame: \[Measurement time, e.g., "After mindfulness-based breathing exercise intervention"\] Unit of Measure: \[Unit of measure, e.g., "scores''\] Scale Title: FACIT-F Scale (Functional Assessment of Chronic Illness Therapy - Fatigue) Scale Range: \[0\] - \[52\] Interpretation: Higher scores indicate higher levels of fatigue.

  Baseline and 6 weeks after intervention

• Sleep quality

  Sleep Quality Measurement Tool: Richard-Campbell Sleep Scale Time Frame: \[Measurement time, e.g., "After mindfulness-based breathing exercise"\] Unit of Measure: \[Unit of measure, e.g., "scores"\] Scale Title: Richard-Campbell Sleep Scale Scale Range: \[0\] - \[21\] Interpretation: Higher scores indicate better outcomes.

  Baseline and 6 weeks after intervention

Study Arms (2)

Intervention phase

EXPERIMENTAL

Mindfulness-based approaches help to focus attention and teach individuals strategies for coping with challenging situations, accepting experiences, building self-confidence, and disengaging. Mindfulness-based practices increase an individual's level of awareness and distance them from current or potential stress factors. In recent years, non-pharmacological complementary and integrative interventions have become more widely used in disease management. Studies supporting the use of mindfulness-based interventions, particularly for the management of acute and chronic pain, have demonstrated biological and psychological improvements. In this study, the aim of the 20-minute mindfulness-based breathing exercise program is to reduce dyspnea and fatigue levels and improve sleep quality in heart failure patients who face many challenging situations. After a pre-test, the experimental group will receive the mindfulness-based breathing exercise program. The program will last for 6 weeks, with

Behavioral: 20-minute mindfulness-based breathing exercise

control phase

EXPERIMENTAL

No intervention would be applied to patients in this group and only pre-test and post-test data would be collected.

Behavioral: Control (Standard treatment)

Interventions

20-minute mindfulness-based breathing exercise BEHAVIORAL

Mindfulness-based approaches help to focus attention and teach individuals strategies for coping with challenging situations, accepting experiences, building self-confidence, and disengaging. Mindfulness-based practices increase an individual's level of awareness and distance them from current or potential stress factors. In recent years, non-pharmacological complementary and integrative interventions have become more widely used in disease management. Studies supporting the use of mindfulness-based interventions, particularly for the management of acute and chronic pain, have demonstrated biological and psychological improvements. In this study, the aim of the 20-minute mindfulness-based breathing exercise program is to reduce dyspnea and fatigue levels and improve sleep quality in heart failure patients who face many challenging situations. After a pre-test, the experimental group will receive the mindfulness-based breathing exercise program. The program will last for 6 weeks, with e

Intervention phase

Control (Standard treatment) BEHAVIORAL

No intervention would be applied to patients in this group and only pre-test and post-test data would be collected.

control phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years of age
• Able to communicate effectively

You may not qualify if:

• Patients with communication problems
• Patients with psychiatric disorders

Sponsors & Collaborators

• Firat University: lead

MeSH Terms

Conditions

Heart Failure; Fatigue; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Gül Dural, PhD

CONTACT

+904242370000; gulkaya@firat.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: July 1, 2025
• Study Start: August 15, 2025
• Primary Completion: September 1, 2025
• Study Completion (Estimated): June 20, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-02