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临床试验/NCT07820059
NCT07820059尚未招募不适用

The Effect of Pranayama Practiced With Rain Sounds on Self-Efficacy, Dyspnea, and Respiratory Functions in Patients With COPD

Inonu University0 个研究点目标入组 114 人开始时间: 2026年8月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
114
主要终点
COPD Self-Efficacy Scale

研究概览

简要总结

Chronic obstructive pulmonary disease (COPD) ranks third among the leading causes of death worldwide. It causes a variety of symptoms resulting from irreversible obstruction of the airways. In addition to pharmacological methods, nonpharmacological methods are also used to alleviate these symptoms. A review of the methods used for this purpose reveals that yoga and breathing exercises are among them. Accordingly, the aim of this study is to investigate the effects of pranayama breathing exercises performed to the sound of rain on dyspnea, self-efficacy, and respiratory function in individuals with chronic obstructive pulmonary disease (COPD). The study, designed as a randomized controlled pre-test/post-test trial, will be conducted at the Turgut Özal Medical Center of İnönü University between April 2026 and September 2027 among patients visiting the Pulmonology Outpatient Clinic. The study will consist of two experimental groups and one control group. Prior to the start of the study, informed consent will be obtained from the patients, and the Patient Demographic Form, COPD Self-Efficacy Scale, Dyspnea 12 Severity Scale, Visual Analog Scale, and Pulmonary Function Test will be administered. The intervention will be administered twice daily for 15-20 minutes over a 6-week period. 1. Patients in the experimental group will have a pranayama breathing exercise video and the sound of rain downloaded to their phones so they can practice at home. 2. Patients in the control group will have only the pranayama breathing exercise video downloaded to their phones so they can practice at home. No intervention will be performed on patients in the control group. Throughout the study, patients will receive daily reminder messages urging them to continue the exercises for 6 weeks. At the end of the 6 weeks, patients will be called to the outpatient clinic, where they will complete the COPD Self-Efficacy Scale, the Dyspnea 12 Severity Scale, the Visual Analog Scale, and a pulmonary function test. To be able to administer the pranayama breathing exercise, the researcher will receive training prior to the study. Based on the results of the study, it is believed that, thanks to the ease of practice of pranayama breathing exercises, they can be performed by nurses on the ward and by patients at home, leading to a reduction in their symptoms.

详细描述

Chronic Obstructive Pulmonary Disease (COPD) is a heterogeneous disease that develops as a result of irreversible airway obstruction and is characterized by lung tissue destruction. COPD is a progressive inflammatory disease of the lungs and is among the most common respiratory diseases (1). The World Health Organization predicts that COPD will rank third among the leading causes of death within the next 10 years (2). The high morbidity and mortality rates associated with COPD also lead to an increased economic burden. Although the prevalence of COPD varies among countries, the risk factors are found to be similar (3). When examining these risk factors, it is evident that there are numerous environmental and genetic factors, such as tobacco use, inhalation of harmful gases, environmental pollution, exposure to mining dust, cooking over open fires, alpha-1-antitrypsin (AAT) deficiency, and mutations in the TNF-α cytokine (4). Inhalation of these harmful gases leads to a pathological inflammatory response, mucus hypersecretion, and alveolar destruction. This, in turn, results in abnormal remodeling of the airways, increased airway resistance, and a decrease in the elasticity of the lung parenchyma (5). The symptoms and signs of the disease worsen as the disease progresses. While mild symptoms such as intermittent coughing, shortness of breath, and reluctance to engage in physically demanding activities are observed in the early stages of the disease, as the disease progresses, many symptoms-such as chronic cough, chest pain, fatigue, weight loss, and increased mucus secretion-become apparent, in contrast to the early stage (6). Individuals with COPD typically present to the hospital with dyspnea, chronic cough, increased sputum production, and wheezing, and many have experienced an exacerbation before seeking hospital care. The diagnosis is made through clinical evaluation and spirometry (7). For a diagnosis of COPD, the post-bronchodilator FEV1/FVC ratio must be less than 0.7. COPD is classified into four stages based on the percentage of FEV1: Stage 1 (FEV1 ≥ 80%), Stage 2 (50% ≤ FEV1 < 79) Stage 3 (30% ≤ FEV1 < 49%) and Stage 4 (FEV1 < 30%) (2). The goal of COPD treatment is to alleviate symptoms and reduce disease severity and the number of exacerbations. To this end, both pharmacological and nonpharmacological methods are used. Pharmacological methods include bronchodilators, antimuscarinic drugs, corticosteroids, phosphodiesterase-4 inhibitors, and mucolytic agents. Treatment is tailored to the patient's symptoms and the number of attacks (8). Nonpharmacological methods include quitting smoking, physical activity, oxygen therapy, nutrition, pulmonary rehabilitation, breathing exercises, and progressive muscle relaxation exercises (9). In addition to pulmonary rehabilitation, yoga-which incorporates breathing exercises-is also among the nonpharmacological methods. Yoga is a spiritual practice consisting of three components: pranayama, asana, and meditation (10). While asana refers to changing one's physical posture, pranayama refers to the expansion of life force through breath control and involves the processes of inhalation and exhalation. There are many different types of asanas, including Sirshana (headstand), Sarvangasana (shoulder stand), Paschimothanasana (seated forward bend), and Padahastasana (standing forward bend), and the purpose of all of them is to increase lung capacity by serving as a preparatory exercise before pranayama (11). Pranayama consists of three steps: Puraka, Rechaka, and Kumbhaka (inhalation, exhalation, and holding the breath after inhalation). While Puraka explains the subtleties of slow inhalation, Rechaka explains the subtleties of slow exhalation. There are many different types of pranayama techniques, including Nadishodhanam, Kapalbhati, Bhastrika, Ujjayi, Bhramari, Sheetali, Sheetkari, Suryabhedana, Murccha, and Plavini.

The purpose of all types of pranayama breathing is to maintain physical and mental health. In addition, each of these pranayama techniques produces different physiological effects depending on its duration and type (12).

• Nadishodhanam (alternate nostril breathing); this is the simplest type of pranayama to practice. It affects the autonomic nervous system, specifically the sympathetic and parasympathetic systems. It involves the following steps (13): Sit in a comfortable position. Use your thumb to close your right nostril and breathe in through your left nostril.

Slowly release your thumb and close your left nostril with your ring finger. Then, exhale slowly through your right nostril, followed by inhaling through your right nostril and exhaling slowly through your left nostril.

• Bhramari pranayama involves inhaling rapidly while making a sound like a male bee and exhaling slowly while making a sound like a female bee (14).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • 18 years of age and older
  • Diagnosed with COPD at least 6 months prior based on pulmonary function test results
  • Stage 1 (FEV1 > 80%), Stage 2 (50% ≤ FEV1 < 80%), and Stage 3 (30% ≤ FEV1 < 50%) patients meeting GOLD 2021 criteria
  • No nasal breathing obstruction
  • Possessing sufficient cognitive ability to understand questions,
  • No visual or hearing problems,
  • No communication problems,
  • Using a smartphone
  • At least literate
  • Volunteering to participate in the study

排除标准

  • • Those who do not wish to continue the practice
  • Those who experience difficulties during the practice
  • Those who begin using any alternative treatment in addition to standard care other than pranayama breathing exercises

研究组 & 干预措施

Pranayama breathing exercise

Experimental

group practicing pranayama breathing exercises

干预措施: pranayama breathing exercises (Other)

Pranayama breathing exercises accompanied by the sound of rain.

Experimental

A group practicing pranayama breathing exercises accompanied by the sound of rain.

干预措施: A group will perform pranayama breathing exercises accompanied by the sound of rain. (Other)

standard maintenance

No Intervention

Rain sounds and pranayama breathing exercises will not be applied to this group.

结局指标

主要结局

COPD Self-Efficacy Scale

时间窗: In the pre-test and post-test phases of the study (at the end of the sixth week), the COPD Self-Efficacy Scale will be administered to experimental groups 1 and 2 one day after the pranayama breathing exercises, and to the control group 6 weeks after the

COPD Self-Efficacy Scale: The COPD Self-Efficacy Scale was developed by Wigal et al. in 1991. In Turkey, its validity and reliability were established by Kara and Mirci (2002). The COPD Self-Efficacy Scale is a 5-point Likert-type scale consisting of 34 items and 5 sub-dimensions that determine the degree of confidence COPD patients have in managing or avoiding shortness of breath during certain activities. The Negative Impact sub-dimension measures the degree of confidence in managing shortness of breath in stressful situations. The Emotional State sub-dimension determines the degree of confidence in coping with shortness of breath in situations of anger, fear, and life-related distress. The Physical Effort sub-dimension measures the level of ability to manage shortness of breath during physical activities such as climbing stairs very quickly and walking. The Weather/Environmental Conditions sub-dimension evaluates coping with situations that may cause shortness of breath, such as co

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Serap Parlar Kılıç

Prof. Dr.

Inonu University

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