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临床试验/NCT04696562
NCT04696562已完成不适用

The Effect of Deep Breathing Exercise Applied With Triflo on Dyspnea, Anxiety and Quality of Life in Patients Treated for COVID-19: Randomized Controlled StudyPatients Treated for COVID-19: A Randomized Controlled Study

Ankara University2 个研究点 分布在 2 个国家目标入组 44 人开始时间: 2021年1月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
2
主要终点
Oxygen saturation (%)

研究概览

简要总结

The world is facing an extremely important global epidemic. Coronavirus disease 2019 (COVID-19) epidemic, which first appeared in Wuhan, China in late 2019 and rapidly affected all countries of the world, was declared as a pandemic by the World Health Organization (WHO) on March 11, 2020. Coronavirus disease 2019 affects both the upper (i.e. sinuses, nose and throat) and lower (i.e. trachea and lungs) airways, causes respiratory tract diseases ranging from asymptomatic or cold to more severe lung diseases (Acute Respiratory Distress Syndrome-ARDS). COVID-19 has many symptoms (i.e. fever, loss of appetite). In cases where the disease has a more severe course, in addition to the symptoms mentioned above, complications such as a severe pneumonia, acute respiratory distress syndrome (ARDS) kidney failure and fatal heart damage may develop. Dyspnea is one of the most prominent symptoms for COVID-19. Since COVID-19 affects the respiratory system, pulmonary rehabilitation has an important place in the treatment of patients. Dyspnea is one of the most prominent symptoms for COVID-19. Our clinical observations are of the opinion that dyspnea is observed even in patients with mild COVID-19 pneumonia. Applying deep breathing exercise with triflo in COVID-19 patients, can contribute to relieving dyspnea, reducing / eliminating anxiety, and increasing quality of life. In the light of this information, the aim of this study is to determine the effect of deep breathing exercise with triflo on dyspnea, anxiety and quality of life in patients with dyspnea who are hospitalized for COVID-19.

Research Hypotheses H1: Patients with COVID-19 pneumonia who undergo deep breathing exercise with triflo will have a lower dyspnea level than the patient group in which this exercise is not applied.

H2: Patients with COVID-19 pneumonia who underwent deep breathing exercise with triflo will have a lower anxiety level than the patient group in whom this exercise was not applied.

H3: Patients with COVID-19 pneumonia who underwent deep breathing exercise with triflo will have a higher quality of life than the patient group in whom this exercise was not applied.

详细描述

The world is facing an extremely important global epidemic. Coronavirus disease 2019 (COVID-19) epidemic, which first appeared in Wuhan, China in late 2019 and rapidly affected all countries of the world, was declared as a pandemic by the World Health Organization (WHO) on March 11, 2020. Coronavirus disease 2019 affects both the upper (i.e. sinuses, nose and throat) and lower (i.e. trachea and lungs) airways, causes respiratory tract diseases ranging from asymptomatic or cold to more severe lung diseases (Acute Respiratory Distress Syndrome-ARDS). COVID-19 has many symptoms. Dyspnea is one of the most prominent symptoms for COVID-19. The relationship between dyspneaand COVID-19 is not fully explained. Our clinical observations are of the opinion that dyspnea is observed even in patients with mild COVID-19 pneumonia.

Since COVID-19 affects the respiratory system, pulmonary rehabilitation has an important place in the treatment of patients. Deep breathing exercise applied within the scope of pulmonary rehabilitation expands the airways, facilitates gas exchange, increases the amount of oxygen reaching the cells, provides the release of tracheabronchial secretions, regulates the pulmonary circulation and thus increases the lung capacity. Deep breathing exercise also plays a role in lowering blood pressure and in reducing / relieving anxiety. Studies have stated that patients who are trained about deep breathing have better exercise status, that deep breathing exercise have increased systolic and diastolic blood pressure of and anxiety at statistically significant level. Triflo is a device that helps the patient to breathe deeply. It is seen as more advantageous in terms of use, as it provides visual information about the depth of breathing. The use of Triflo is used to support the determination of the patient's inspiration capacity, normal inspiration and deep breathing.

COVID-19, it has been determined that it improves respiratory function, quality of life and anxiety of the elderly and has little effect on depression.

The effects of COVID-19 disease on the lung and respiratory system appear to be quite serious. Since there is not enough information about the long-term results yet, its effect on patients and lungs after active period is not clearly known. The one of the most important data the investigators have now is that most of the patients experience dyspnea. In the literature, there has been no study examining the effect of respiratory exercise on dyspnea, anxiety and quality of life in patients diagnosed with COVID-19 pneumonia. However, applying deep breathing exercise with triflo in COVID-19 patients, can contribute to relieving dyspnea, reducing / eliminating anxiety, reducing / eliminating respiratory system complications, preserving / improving respiratory function, maintaining or increasing lung volume, accelerating recovery and increasing quality of life. In the light of this information, the aim of this study is to determine the effect of deep breathing exercise with triflo on dyspnea, anxiety and quality of life in patients with dyspnea who are hospitalized for COVID-19.

MATERIALS AND METHODS This single-centered, randomized controlled study will be held in Ankara city hospital in Turkey. Ethics committee approval was obtained from Ankara City Hospital Ethics Committee (Date:12/23/2020 Number:E.Kurul-E1-20-1403). The investigators also have received permission from the Ministry of Health of the Republic of Turkey for the study (Date:12/04/2020- Name and number: Hatice ÖNER CENGİZ-2020-12-04T12_09_16). Before the study, "enlightened informed consent" will be obtained from all participants. The entire study will be conducted in accordance with the Consolidated Standards of Reporting Trials (CONSORT) 2010 guidelines and directives.

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
None

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

  • The patients,
  • who are in clinical treatment for COVID-19 pneumonia;
  • who are 18 years of age or older, mentally healthy;
  • who can speak and understand Turkish;
  • who owns and can use smartphones;
  • who suffer from dyspnea,
  • who do not have chronic diseases related to the respiratory system (lung diseases, heart diseases, etc.);
  • who are volunteers, will be included in the study.

排除标准

  • The Patients
  • for whom the data required for the study could not be collected;
  • who are unable to complete the work (not wanting to continue working, transferred to the intensive care unit and died);
  • who do not agree to participate in the study, will be excluded.

结局指标

主要结局

Oxygen saturation (%)

时间窗: until the treatment is completed,an average of 7 days

Oxygen saturation (%) The oxygen saturation of the patient from the fingertips of the patients will be evaluated by the researchers using the same pulse oximeter device everyday.

Dyspnea level

时间窗: until the treatment is completed,an average of 7 days

The dyspnea level of the patients will be evaluated with the Dyspnea-12 form.Dyspnea-12 scale is a scale that measures the severity of dyspnea (shortness of breath) and consists of 2 sub-dimensions and a total of 12 items.

Respiratory rate per minute

时间窗: until the treatment is completed,an average of 7 days

The respiratory rate of the patient will be evaluated by the researchers every day by counting the respiratory rate per minute.

次要结局

  • Quality of life level(post-treatment change (one week change))
  • Anxiety(post-treatment change (one week change))

研究者

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

Hatice ÖNER CENGİZ

Lecturer PhD.

Ankara University

研究点 (2)

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