Clinical trial NCT06519188: The Effect of Salt Water Nebulization on Cough, Sputum and Quality of Life in Chronic Obstructive Pulmonary Patients
Official title: The Effect of Salt Water Application on Cough, Sputum, Dyspnea Management and Quality of Life in Individuals With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Copd
Keywords: quality of life
cough
dyspnea
COPD
saline water
nursing
Lead sponsor: Ministry of Health, Turkey
Sponsor class: OTHER_GOV
First posted: 2024-07-25
Enrollment: 81
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pretest, posttest randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.).

Primary outcomes:
measure: The effect of salt water application on cough in individuals diagnosed with COPD after a 8 weeks period.
timeFrame: Base week and measurement interval is 8 weeks.
measure: The effect of salt water application on sputum management in individuals diagnosed with COPD after a 8 weeks period.
timeFrame: Base week and measurement interval is 8 weeks.
Secondary outcomes:
measure: The effect of salt water application on dyspnea management in individuals diagnosed with COPD after a 8 weeks period.
timeFrame: Base week and measurement interval is 8 weeks.
measure: The effect of salt water application on quality of life in individuals diagnosed with COPD after a 8 weeks period.
timeFrame: Base week and measurement interval is 8 weeks.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yedikule Chest Surgeory and Chest Disease Hospital
state: Zeytinburnu
Study officials:
affiliation: MOH TURKEY
name: ZELIHA ERMIS
role: PRINCIPAL_INVESTIGATOR
References: