Effects of a 20-Minute Mindfulness-Based Breathing Exercise on Dyspnea, Fatigue, and Sleep Quality in Patients With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 主要终点
- dyspnea severity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years of age
- •Able to communicate effectively
- •No psychiatric disorders
排除标准
- •Patients with communication problems
- •Patients with psychiatric disorders
研究组 & 干预措施
Intervention phase
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
干预措施: 20-minute mindfulness-based breathing exercise (Behavioral)
control phase
No intervention would be applied to patients in this group and only pre-test and post-test data would be collected.
干预措施: Control (Standard treatment) (Behavioral)
结局指标
主要结局
dyspnea severity
时间窗: 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
时间窗: 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
时间窗: 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.
Fatigue Severity
时间窗: 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.
dyspnea severity
时间窗: 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.
Sleep quality
时间窗: 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.
次要结局
未报告次要终点
研究者
Gui Dural
Associate professor
Firat University