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

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

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.

Study Overview

• Status: Completed
• Conditions: Copd
• Intervention / Treatment: Other: Nebulization application with 5 ml isotonic sodium chloride

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.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Zeytinburnu
    • Istanbul, Zeytinburnu, Turkey, 34020
      • Yedikule Chest Surgeory and Chest Disease Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Nebulization application with 5 ml isotonic sodium chloride; Nebulization application with 5 ml isotonic sodium chloride in the morning and evening for two months.
No Intervention: NON APLICATION GROUP; No intervention was performed on control group patients who volunteered for the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of salt water application on cough in individuals diagnosed with COPD after a 8 weeks period.	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.	Base week and measurement interval is 8 weeks.
The effect of salt water application on sputum management in individuals diagnosed with COPD after a 8 weeks period.	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.	Base week and measurement interval is 8 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of salt water application on dyspnea management in individuals diagnosed with COPD after a 8 weeks period.	The Modified Medical Research Council Scale dyspnea scale is a five-item scale based on various physical activities that create a feeling of dyspnea. In this scale, "0" (NO DYSPNEA) and "4" (WORST DYSPNEA). As the score obtained from the scale increases, the rate of being affected by COPD also increases.	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.	St. George's Respiratory Questionnaire with Quality of life were monitored in patients every 14 days and for the following 8 weeks. A score of zero (0) Good state of health, and (100) indicates the most severe disease.	Base week and measurement interval is 8 weeks.

Collaborators and Investigators

• Sponsor: Ministry of Health, Turkey
• Investigators: Principal Investigator: ZELIHA ERMIS, MOH TURKEY

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2022
• Primary Completion (Actual): May 28, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: June 30, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 28, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; COPD; nursing; cough; dyspnea; saline water
• Other Study ID Numbers: Salt Water Nebulization

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The part of this study that can be shared is the statistical information and results.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No