The Effect of Slow-Paced Breathing on Patient Outcomes in Pulmonary Arterial Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Multidimensional Dyspnea Profile
研究概览
简要总结
This study aims to investigate the effects of slow-paced breathing (SPB) intervention applied to patients with pulmonary arterial hypertension (PAH) in the home environment on symptom management (dyspnea, fatigue, sleep quality), clinical parameters (Six-Minute Walking Test-6MWT), IL-6, NT-proBNP results) and quality of life.
详细描述
The therapeutic power of slow, controlled breathing has been recognized for centuries and is primarily used in relaxation techniques such as meditation and yoga.
It can be difficult for a patient to effectively perform these exercises on their own without training or individualized coaching.
Numerous studies in recent years have shown that therapeutic breathing exercises performed without conscious effort, using devices, have positive effects on parameters such as blood pressure, stress management, respiratory modulation, sleep difficulties, and quality of life.
Furthermore, the effects of slow-paced breathing performed with conscious effort using visual and auditory triggers have also been demonstrated in many studies.
Slow-paced breathing is a breathing technique that aims to slow the inhalation and exhalation phases to a controlled rate determined by a visual, auditory, or kinesthetic pacer.
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
- Double (Participant, Outcomes Assessor)
盲法说明
In this randomized controlled experimental study, Excel random numbers function was used as the randomization method.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being between 18 and 65 years of age
- •Being diagnosed with PAH (pulmonary arterial hypertension)- (Group I pulmonary hypertension (idiopathic, hereditary, drug or toxin-induced, or associated with connective tissue disease, congenital heart disease, or HIV-associated)) diagnosed by right heart catheterization
- •Being on stable PAH treatment for the past three months and in a stable clinical condition (no changes in PAH medical treatment, no new medications added)
- •Being in class II or III according to the World Health Organization functional classification
- •Being able to speak Turkish
- •Having a high level of technical digital literacy (obtaining the highest score (30 points) on the "technical subscale" of the Digital Literacy Scale*)
- •Agreeing to participate in the study
排除标准
- •Communication difficulties
- •Symptomatic hypotension
- •Pregnancy status for female participants (positive urine pregnancy test*)
- •Presence of another underlying condition that may cause dyspnea, fatigue, and sleep difficulties (chronic fatigue syndrome, obstructive sleep apnea, restless legs syndrome, narcolepsy, major depression, etc.)
- •Hospitalization or acute phase
- •Active participation in a cardiac rehabilitation program
- •Presence of pulmonary hypertension due to left heart disease and pulmonary hypertension due to lung diseases and/or hypoxia
- •Receiving a lung transplant
- •Having had cardiac surgery within the last six months
- •Presence of obesity
- •Presence of mental retardation
结局指标
主要结局
Multidimensional Dyspnea Profile
时间窗: Baseline, at the end of six weeks and at the end of twelve weeks
The multidimensional dyspnea profile consists of subheadings assessing immediate perception (6 items; total score range 0-60) and emotional reactions (5 items; total score range 0-50). Items are rated on a 0-10 scale, with higher scores indicating greater intensity, unpleasantness, or distress.
Multidimensional Fatigue Inventory
时间窗: Baseline, at the end of six weeks and at the end of twelve weeks
The inventory contains five subscales measuring general fatigue (items 1, 5, 12, and 16), physical fatigue (items 2, 8, 14, and 20), decreased activity (items 3, 6, 10, and 17), decreased motivation (items 4, 9, 15, and 18), and mental fatigue (items 7, 11, 13, and 19), totaling 20 items.
Pittsburgh Sleep Quality Index
时间窗: Baseline, at the end of six weeks and at the end of twelve weeks
The index is a self-report measure that provides a quantitative measure of sleep quality to describe good and poor sleep over a one-month period. It consists of seven subcomponents and 24 items, 19 of which are self-reported and five of which are self-reported or evaluated by a roommate, if present.
Six-Minute Walk Test Form and Modified Borg Scale
时间窗: Baseline, and at the end of twelve weeks
The 6MWT (Six-Minute Walk Test), the most commonly used exercise test in monitoring patients with pulmonary hypertension, is an easy-to-administer and inexpensive test. Walking speed should be determined by the patient, but the goal of the test is to walk as far as possible in six minutes. The Modified Borg Scale, a unidimensional scale, is a subjective, reliable, and easily administered tool for determining the severity of dyspnea and fatigue perceived by the patient at rest and during exertion. The scale identifies the severity of dyspnea/fatigue by rating (0 to 10), with a score of 0 indicating "absent" and a score of 10 indicating "maximum" dyspnea/fatigue.
Laboratory Analysis Form
时间窗: Baseline, and at the end of twelve weeks
It is recommended to monitor certain variables (NT-proBNP) at regular intervals during the diagnosis and follow-up phases of the disease. These variables can be used to assess prognosis and risk stratify, while also guiding the treatment protocol. In addition, some studies have used IL-6 as an indicator of inflammation and correlated it with sleep quality.
EmPHasis-10 Quality of Life Scale
时间窗: Baseline, at the end of six weeks and at the end of twelve weeks
This 10-question scale, developed for patients with pulmonary hypertension, addresses concerns about the disease's significant effects, such as shortness of breath, fatigue, and lack of energy, as well as its impact on social relationships. Each question on the scale has a score between 0 and 5 and is assessed using a Likert scale.
次要结局
未报告次要终点