Heart FailureNCT07046091
Effects of a 20-Minute Mindfulness-Based Breathing Exercise on Dyspnea, Fatigue, and Sleep Quality in Patients With Heart Failure
A study testing 20-minute mindfulness-based breathing exercise in people with Heart Failure and Heart Failure - NYHA II - IV, run by Firat University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Heart Failure - NYHA II - IV
- What is being tested?
- 20-minute mindfulness-based breathing exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2025to 20 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years of age
- Able to communicate effectively
- No psychiatric disorders Exclusion Criteria
- Patients with communication problems
- Patients with psychiatric disorders
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
Read the detailed description
Heart failure, with a global prevalence of 26 million, is a leading cause of morbidity and mortality. Compared to its corrected incidence, the prevalence of heart failure is expected to rise due to the aging population. Hospital admissions due to heart failure impose a significant socioeconomic burden, especially due to increasing healthcare costs. It is estimated that more than half of the total expenditures related to heart failure are due to hospital admissions, while pharmacotherapy contributes to 18% of the cost.
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 remains characterized by debilitating symptoms and rehospitalizations. Generalized muscle atrophy, including inspiratory muscle atrophy, is often observed in patients with heart failure. Weakness of the respiratory muscles during exercise and activity can lead to fatigue and shortness of breath.
Dyspnea, early fatigue, exercise intolerance, and reduced life expectancy are common symptoms and signs of heart failure, characterized by the inability of the heart to meet the metabolic demands of tissues. In a study conducted on patients with heart failure, the frequency of severe dyspnea was reported as 69%. The mechanism of dyspnea is multifactorial. Dyspnea can exacerbate fatigue by limiting daily activities in HF patients .
Fatigue is also a prototypical symptom of heart failure. In a study, 59% of HF patients reported moderate to severe fatigue. Fatigue is a reflection of muscle hypoperfusion and is an indicator of reduced cardiac output, with its intensity related to depression, muscle dysfunction, and symptoms of anemia. Fatigue is also an independent predictor of increased cardiac readmission and mortality rates in HF patients. It can be explained by clinical factors such as age, anemia, poor sleep quality, reduced exercise capacity, dyspnea, and psychosocial distress.
Changes in sleep patterns in heart failure patients can negatively affect the prognosis of the disease. Pharmacological methods are the most known and frequently used treatments for patients with sleep problems. However, it is also known that long-term use of medications for sleep problems has the potential to cause serious side effects. Therefore, in recent years, non-pharmacological methods are also being utilized to improve sleep quality in individuals with sleep issues.
Non-pharmacological treatments can be beneficial for HF patients. Research evidence shows that non-pharmacological interventions, especially breathing training, have benefits on dyspnea and anxiety in patients with heart failure. For example, a mindfulness-based psychoeducation intervention, which focuses on cognitively separating bodily sensations from stimulated thoughts and emotions, has been shown to significantly reduce anxiety in patients with chronic heart failure and improve their symptoms. Mindfulness involves consciously paying attention to the present moment in a non-reactive way. It has been shown to reduce stress, anxiety, and depression while improving sleep. Although there is growing evidence supporting the application of mindfulness in various chronic diseases, its benefit in reducing dyspnea remains uncertain. However, most of the evidence on the benefits of mindfulness comes from traditional 6-8 week mindfulness programs. Short mindfulness practices, lasting 5-30 minutes, warrant further research. Recent studies have shown that a single 20-minute mindful breathing session significantly reduced dyspnea in patients with chronic lung disease and decompensated heart failure.
Mindful breathing is an exercise that involves paying attention to one's breath without distraction from external or internal experiences. This maneuver has been shown to relieve distress in patients in palliative care and reduce dyspnea in patients with chronic lung disease. A recent study reported that an 8-week mindfulness-based intervention reduced dyspnea, fatigue, and dizziness symptoms in symptomatic congestive heart failure outpatients compared to traditional treatment alone.
Short mindfulness practices require less energy and time from patients and have the potential to create more sustainable habits when practiced regularly. However, evidence for their effectiveness in reducing fatigue is still lacking. A literature review found that there is insufficient research on mindfulness-based breathing exercises for heart failure patients. This study is expected to contribute to the nursing literature. 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
- Being tested
- 20-minute mindfulness-based breathing exercise, Control (Standard treatment)
- Keywords
- heart failure, mindfulness, dsypnea, fatigue, sleep quality
- Medical subject headings
- Heart Failure, Fatigue, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20-minute mindfulness-based breathing exerciseBehavioural
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
Control (Standard treatment)Behavioural
No intervention would be applied to patients in this group and only pre-test and post-test data would be collected.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Control (Standard treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 6 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start15 Aug 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion20 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gui Dural, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046091
- Sponsor's protocol ID
- FUGDRL-001
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a 20-Minute Mindfulness-Based Breathing Exercise on Dyspnea, Fatigue, and Sleep Quality in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT07046091
- Acronym / sponsor ID
- FUGDRL-001
- Conditions
- Heart Failure, Heart Failure - NYHA II - IV
- Keywords
- heart failure, mindfulness, dsypnea, fatigue, sleep quality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 20 Jun 2026 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Heart failure, with a global prevalence of 26 million, is a leading cause of morbidity and mortality. Compared to its corrected incidence, the prevalence of heart failure is expected to rise due to the aging population. Hospital admissions due to heart failure impose a significant socioeconomic burden, especially due to increasing healthcare costs. It is estimated that more than half of the total expenditures related to heart failure are due to hospital admissions, while pharmacotherapy contributes to 18% of the cost.
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 remains characterized by debilitating symptoms and rehospitalizations. Generalized muscle atrophy, including inspiratory muscle atrophy, is often observed in patients with heart failure. Weakness of the respiratory muscles during exercise and activity can lead to fatigue and shortness of breath.
Dyspnea, early fatigue, exercise intolerance, and reduced life expectancy are common symptoms and signs of heart failure, characterized by the inability of the heart to meet the metabolic demands of tissues. In a study conducted on patients with heart failure, the frequency of severe dyspnea was reported as 69%. The mechanism of dyspnea is multifactorial. Dyspnea can exacerbate fatigue by limiting daily activities in HF patients .
Fatigue is also a prototypical symptom of heart failure. In a study, 59% of HF patients reported moderate to severe fatigue. Fatigue is a reflection of muscle hypoperfusion and is an indicator of reduced cardiac output, with its intensity related to depression, muscle dysfunction, and symptoms of anemia. Fatigue is also an independent predictor of increased cardiac readmission and mortality rates in HF patients. It can be explained by clinical factors such as age, anemia, poor sleep quality, reduced exercise capacity, dyspnea, and psychosocial distress.
Changes in sleep patterns in heart failure patients can negatively affect the prognosis of the disease. Pharmacological methods are the most known and frequently used treatments for patients with sleep problems. However, it is also known that long-term use of medications for sleep problems has the potential to cause serious side effects. Therefore, in recent years, non-pharmacological methods are also being utilized to improve sleep quality in individuals with sleep issues.
Non-pharmacological treatments can be beneficial for HF patients. Research evidence shows that non-pharmacological interventions, especially breathing training, have benefits on dyspnea and anxiety in patients with heart failure. For example, a mindfulness-based psychoeducation intervention, which focuses on cognitively separating bodily sensations from stimulated thoughts and emotions, has been shown to significantly reduce anxiety in patients with chronic heart failure and improve their symptoms. Mindfulness involves consciously paying attention to the present moment in a non-reactive way. It has been shown to reduce stress, anxiety, and depression while improving sleep. Although there is growing evidence supporting the application of mindfulness in various chronic diseases, its benefit in reducing dyspnea remains uncertain. However, most of the evidence on the benefits of mindfulness comes from traditional 6-8 week mindfulness programs. Short mindfulness practices, lasting 5-30 minutes, warrant further research. Recent studies have shown that a single 20-minute mindful breathing session significantly reduced dyspnea in patients with chronic lung disease and decompensated heart failure.
Mindful breathing is an exercise that involves paying attention to one's breath without distraction from external or internal experiences. This maneuver has been shown to relieve distress in patients in palliative care and reduce dyspnea in patients with chronic lung disease. A recent study reported that an 8-week mindfulness-based intervention reduced dyspnea, fatigue, and dizziness symptoms in symptomatic congestive heart failure outpatients compared to traditional treatment alone.
Short mindfulness practices require less energy and time from patients and have the potential to create more sustainable habits when practiced regularly. However, evidence for their effectiveness in reducing fatigue is still lacking. A literature review found that there is insufficient research on mindfulness-based breathing exercises for heart failure patients. This study is expected to contribute to the nursing literature. 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention phase | Experimental | Behavioral: 20-minute mindfulness-based breathing exerciseMindfulness-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 |
| control phase | Experimental | Behavioral: Control (Standard treatment)No intervention would be applied to patients in this group and only pre-test and post-test data would be collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Over 18 years of age
- Able to communicate effectively
- No psychiatric disorders Exclusion Criteria
- Patients with communication problems
- Patients with psychiatric disorders
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 20-minute mindfulness-based breathing exerciseMindfulness-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 | Behavioural | Intervention phase |
| Control (Standard treatment)No intervention would be applied to patients in this group and only pre-test and post-test data would be collected. | Behavioural | control phase |
Primary outcome
dyspnea severity
Time frame: Baseline and 6 weeks after intervention
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.
Fatigue Severity
Time frame: Baseline and 6 weeks after intervention
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.
Sleep quality
Time frame: Baseline and 6 weeks after intervention
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing 20-minute mindfulness-based breathing exercise in people with Heart Failure and Heart Failure - NYHA II - IV, run by Firat University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gül Dural, PhD (+904242370000, gulkaya@firat.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dyspnea severity (time frame: Baseline and 6 weeks after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.