CopdNCT06519188
The Effect of Salt Water Nebulization on Cough, Sputum and Quality of Life in Chronic Obstructive Pulmonary Patients
A study testing Nebulization application with 5 ml isotonic sodium chloride in people with Copd, run by Ministry of Health, Turkey at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Copd
- What is being tested?
- Nebulization application with 5 ml isotonic sodium chloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Feb 2022to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yedikule Chest Surgeory and Chest Disease Hospital
Istanbul, Zeytinburnu, 34020
About this study
Official title: 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.
Read the 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
- Being tested
- Nebulization application with 5 ml isotonic sodium chloride
- Keywords
- quality of life, cough, dyspnea, COPD, saline water, nursing
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cough, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulization application with 5 ml isotonic sodium chlorideOther
Nebulization application with 5 ml isotonic sodium chloride in the morning and evening for two months.
| Study group | Role | What they receive |
|---|---|---|
| NEBUL APPLICATION GROUP | Experimental | 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. Receives: Other: Nebulization application with 5 ml isotonic sodium chloride |
| NON APLICATION GROUP | No intervention | No intervention was performed on control group patients who volunteered for the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Base week and measurement interval is 8 weeks.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Base week and measurement interval is 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start28 Feb 2022
- Primary completion28 May 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pretest, posttest randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Turkey
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zeliha Ermiş, Ministry of Health, Turkey
- Investigators
- ZELIHA ERMIS, Principal investigator, MOH TURKEY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519188
- Sponsor's protocol ID
- Salt Water Nebulization
- Status last verified
- Jul 2024
- First submitted
- 30 Jun 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The part of this study that can be shared is the statistical information and results.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Salt Water Application on Cough, Sputum, Dyspnea Management and Quality of Life in Individuals With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06519188
- Acronym / sponsor ID
- Salt Water Nebulization
- Conditions
- Copd
- Keywords
- quality of life, cough, dyspnea, COPD, saline water, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Ministry of Health, TurkeyOther government
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 28 May 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- pretest, posttest randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| NEBUL APPLICATION GROUP | Experimental | Other: Nebulization application with 5 ml isotonic sodium chlorideThe 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. |
| NON APLICATION GROUP | No intervention | –No intervention was performed on control group patients who volunteered for the study. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nebulization application with 5 ml isotonic sodium chlorideNebulization application with 5 ml isotonic sodium chloride in the morning and evening for two months. | Other | NEBUL APPLICATION GROUP |
Primary outcome
The effect of salt water application on cough in individuals diagnosed with COPD after a 8 weeks period.
Time frame: 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.
Time frame: 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.
2 secondary outcomes
The effect of salt water application on dyspnea management in individuals diagnosed with COPD after a 8 weeks period.
Time frame: 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.
Time frame: Base week and measurement interval is 8 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No. The part of this study that can be shared is the statistical information and results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ZELIHA ERMIS principal investigator
MOH TURKEY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nebulization application with 5 ml isotonic sodium chloride in people with Copd, run by Ministry of Health, Turkey at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of salt water application on cough in individuals diagnosed with COPD after a 8 weeks period. (time frame: Base week and measurement interval is 8 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.