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临床试验/NCT06519188
NCT06519188已完成不适用

The Effect of Salt Water Application on Cough, Sputum, Dyspnea Management and Quality of Life in Individuals With Chronic Obstructive Pulmonary Disease

Ministry of Health, Turkey2 个研究点 分布在 2 个国家目标入组 81 人开始时间: 2022年2月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
81
试验地点
2
主要终点
The effect of salt water application on cough in individuals diagnosed with COPD after a 8 weeks period.

研究概览

简要总结

The aim of this clinical trial is to evaluate the effects of salt-water nebulization on individuals with chronic obstructive pulmonary disease. The main questions it aims to answer are:

Does salt-water application have an effect on cough and sputum management in individuals with COPD diagnosis? Does salt-water application have an effect on dyspnea management in individuals with COPD diagnosis? Does salt-water application have an effect on the quality of life in individuals with COPD diagnosis? The work was continued with two groups that did and did not practice. The group who made the application made the application twice a day every day for 2 months. The results of both groups were compared.

详细描述

In order to ensure randomization, the control group patient was selected on one day of the week and on the other day of the experiment. The patients were selected to be 50 people in the experimental group and 50 people in the control group. The experimental group was completed with 37 patients and the control group with 44 patients. The data were collected from the Patient Information Form, Modified Medical Research Council Scale/Medical Research Board Scale (MMRC), COPD Assessment Test (CAT), St. George was collected by Respiratory Survey. SPSS (IBM SPSS Statistics 27) package program was used for statistical analysis. Descriptive statistics and frequency tables were used in the interpretation of the findings. Parametric methods were used for the measurement values in accordance with the normal distribution. In accordance with parametric methods, the "Paired-Sample" test (t-table value) method was used to compare the measurement values of the two dependent groups. Non-parametric methods were used for measurement values that do not correspond to the normal distribution. In accordance with non-parametric methods, the "Mann-Whitney U" test (Z-table value) was used to compare the measurement values of two independent groups, and the "Friedman" test (χ2-table value) was used to compare the measurement values of three or more dependent groups. The "Pearson-χ2" cross tables were used to examine the relationships of the two qualitative variables to each other. The "Spearman" correlation coefficient was used to examine the relationships of two quantitative variables with each other.

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
35 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 35 years and above,
  • Volunteer to participate in the research,
  • Diagnosed with Stable COPD by the physician,
  • Those who have not had an attack in the last month (are stable in terms of drug treatment),
  • Having no vision, speech or hearing problems that would prevent understanding and applying the information given,
  • Those who have smoked for at least 10 years or more,
  • Individuals who are mentally competent (without intellectual disability).

排除标准

  • Those who do not want to participate in the research,
  • Hearing-speech impaired,
  • Unable to communicate due to speaking different languages,
  • Patients diagnosed by a physician with hypertension, ischemic heart disease, congestive heart failure, atrial fibrillation, chronic renal failure, stroke and other cerebrovascular disease, angina, major psychiatric disease (dementia, schizophrenia, etc.).

结局指标

主要结局

The effect of salt water application on cough in individuals diagnosed with COPD after a 8 weeks period.

时间窗: Base week and measurement interval is 8 weeks.

COPD Assesment Test's 1st question is belong to cough. The cough assessment of the patients was evaluated from "0" (no cough) to "5" (a lot of coughing). As the score obtained from the scale increases, the rate of being affected by COPD also increases.

The effect of salt water application on sputum management in individuals diagnosed with COPD after a 8 weeks period.

时间窗: Base week and measurement interval is 8 weeks.

COPD Assesment Test's 2nd question is belong to sputum. The sputum assessment of the patients was evaluated from "0" (no sputum) to "5" (a lot of sputum). As the score obtained from the scale increases, the rate of being affected by COPD also increases.

次要结局

  • The effect of salt water application on dyspnea management in individuals diagnosed with COPD after a 8 weeks period.(Base week and measurement interval is 8 weeks.)
  • The effect of salt water application on quality of life in individuals diagnosed with COPD after a 8 weeks period.(Base week and measurement interval is 8 weeks.)

研究者

发起方
Ministry of Health, Turkey
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Zeliha Ermiş

Head Investigator

Ministry of Health, Turkey

研究点 (2)

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