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Recruiting NCT07000604

Effect of ınhaler Use on Oral Health in COPD Patients

No phase Interventional Chronic Obstructive Pulmonary Disease (COPD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mouth Care Training.
Who it may be relevant to
Registry conditions: Chronic Obstructive Pulmonary Disease (COPD). Basic parameters: 35 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Inhaler Medication Use on Oral Health in COPD Patients: A Randomized Controlled Trial

Overview

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

Interventions

  • Other Mouth Care Training
    Patients will be educated on how to care for their mouths after using inhaled medication.

Primary outcome measures

  • Oral Health Status with Oral Assessment Guide [Time frame: Baseline and 3 months after intervention]
Secondary outcome measures (1)
  • Medication Adherence with Medication Adherence Reporting Scale [Time frame: Baseline and 3 months after intervention]

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,

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Çankiri Devlet Hastanesi — Çankırı

Identifiers

NCT: NCT07000604 · 03-07-2024-15-COPD01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗