Effect of ınhaler Use on Oral Health in COPD Patients

NCT07000604 | Recruiting

• 1 other identifier: 03-07-2024-15-COPD01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to evaluate the effect of oral health education given to individuals diagnosed with COPD and using inhaled medication.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• Oral Health Status with Oral Assessment Guide

  Oral health status will be assessed using the Oral Assessment Guide. After the training, the scores of the trained group and the untrained group will be compared to determine the effect of oral care training. Each change in oral health is scored between 1 and 3 points and these points are added to obtain a total score. The guide supports the creation of an oral care protocol for a patient with a deteriorated oral mucous membrane. The scores that can be obtained from the guide vary between 8 and 24. A total oral mucous membrane score (OMP) between 8 and 14 indicates "oral-mucous membrane deterioration risk", while a score between 14 and 24 indicates "oral mucous membrane deterioration". According to the oral assessment guide, individuals with low scores indicate that their oral health is good, while high scores indicate a negative change in oral health.

  Baseline and 3 months after intervention

Secondary Outcomes (1)

• Medication Adherence with Medication Adherence Reporting Scale

  Baseline and 3 months after intervention

Study Arms (1)

DENEY GRUBU

OTHER

Oral care training will be given to 40 randomly selected patients and their oral health will then be evaluated.

Other: Mouth Care Training

Interventions

Mouth Care Training OTHER

Patients will be educated on how to care for their mouths after using inhaled medication.

DENEY GRUBU

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with COPD for at least 6 months,
• Outpatient and inpatient,
• Consent to participate in the research,
• Not under the age of eighteen,
• With a metered dose inhaler (MDI) in treatment,
• No communication barriers,
• No COPD exacerbation and/or respiratory tract infection,
• According to the GOLD report; mild (Stage 1), moderate (Stage 2), severe (Stage 3).

You may not qualify if:

• Diagnosed with COPD for less than 6 months,
• Refused to participate in the research,
• Treatment without metered dose inhalers (MDIs),
• Uncommunicative,
• Those who withdrew from participating in the study during data collection,
• Not completing the survey,
• COPD exacerbation and/or respiratory tract infection,

Sponsors & Collaborators

• Çankırı Karatekin University: lead

Study Sites (1)

Çankiri Devlet Hastanesi

Çankırı, 18000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Betül Yalçın, 2

  Çankırı Karatekin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

BETÜL YALÇIN, 2

CONTACT

+905536048980; betulozylmz@gmail.com

özlem bulantekin düzalan, 1

CONTACT

+905063801930; ozlembulantekin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: NURSE

Model Details: EXPERIMENTAL AND CONTROL GROUP

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: June 3, 2025
• Study Start: May 30, 2025
• Primary Completion: August 30, 2025
• Study Completion: October 30, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)