NCT06519188

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

June 30, 2024

Last Update Submit

July 28, 2024

Conditions

Keywords

quality of lifecoughdyspneaCOPDsaline waternursing

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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.

Study Arms (2)

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.

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.

Interventions

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

NEBUL APPLICATION GROUP

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yedikule Chest Surgeory and Chest Disease Hospital

Istanbul, Zeytinburnu, 34020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveCoughDyspnea

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • ZELIHA ERMIS

    MOH TURKEY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: pretest, posttest randomized controlled trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Investigator

Study Record Dates

First Submitted

June 30, 2024

First Posted

July 25, 2024

Study Start

February 28, 2022

Primary Completion

May 28, 2022

Study Completion

December 30, 2022

Last Updated

July 30, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

The part of this study that can be shared is the statistical information and results.

Locations