The Effect of Salt Water Nebulization on Cough, Sputum and Quality of Life in Chronic Obstructive Pulmonary Patients

NCT ID: NCT06519188

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-28
• Study Completion Date: 2022-12-30

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.

Conditions

Copd

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

NEBUL APPLICATION GROUP

The experimental group patients were taught the method of nebulization with 5 ml isotonic sodium chloride. Patients were asked to perform the application twice a day, in the morning and in the evening, for two months.

Group Type: EXPERIMENTAL

Nebulization application with 5 ml isotonic sodium chloride

Intervention Type: OTHER

Nebulization application with 5 ml isotonic sodium chloride in the morning and evening for two months.

NON APLICATION GROUP

No intervention was performed on control group patients who volunteered for the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nebulization application with 5 ml isotonic sodium chloride

Nebulization application with 5 ml isotonic sodium chloride in the morning and evening for two months.

Intervention Type: 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.).

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Turkey

OTHER_GOV

Sponsor Role: lead

Responsible Party

Zeliha Ermiş

Head Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ZELIHA ERMIS

Role: PRINCIPAL_INVESTIGATOR

MOH TURKEY

Locations

Yedikule Chest Surgeory and Chest Disease Hospital

Istanbul, Zeytinburnu, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Salt Water Nebulization

Identifier Type: -

Identifier Source: org_study_id