Clinical trial NCT07000604: Effect of ınhaler Use on Oral Health in COPD Patients
Official title: Effect of Inhaler Medication Use on Oral Health in COPD Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: Çankırı Karatekin University
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 80
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: EXPERIMENTAL AND CONTROL GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Before the research data are collected, the purpose, content, scope and duration of the research will be explained in one-to-one interviews with the participants. Verbal and written informed consent will be obtained from the participants. After the participants gave consent to the study, they will be divided into intervention and control groups by simple random sampling method. Participants will be asked to answer the questions in the data collection tools as they see fit and to answer all of the questions. The data collection form will be applied through face-to-face interviews with participants who meet the inclusion criteria. After each completed questionnaire, the researchers will check whether the answers to the survey questions are missing. When unanswered questions are identified, participants will be invited to fill in the missing information. The completion of the questionnaires and training is planned to take an average of 20-25 minutes for each participant. The experimental group will receive training intervention. No education will be given to the control group. After 3 months, an appointment will be made to evaluate oral health

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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,

Primary outcomes:
measure: Oral Health Status with Oral Assessment Guide
timeFrame: Baseline and 3 months after intervention
Secondary outcomes:
measure: Medication Adherence with Medication Adherence Reporting Scale
timeFrame: Baseline and 3 months after intervention
Other outcomes:
Locations:
city: Çankırı
country: Turkey
facility: Çankiri Devlet Hastanesi
Study officials:
affiliation: Çankırı Karatekin University
name: Betül Yalçın, 2
role: PRINCIPAL_INVESTIGATOR
References: