Effect of Telenursing on Oral Health

March 5, 2026 updated by: Sevda Ateş, Çanakkale Onsekiz Mart University

The Effect of Telenursing Interventions on Oral Health in Individuals With COPD

This research will be conducted using a pre-test and post-test control group experimental design to evaluate the effect of telenursing intervention on oral health in individuals with COPD.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Studies evaluating the effectiveness of oral health interventions in individuals with COPD are limited in the literature. Maintaining oral health is a crucial part of patient care. Sustainable nursing interventions are necessary from the onset of the disease to the end of life. Patient education conducted by nurses is important in improving medication adherence and preventing comorbidities. Furthermore, it is known that practices involving a multidisciplinary team approach with nurse participation reduce readmissions and hospital stays for COPD patients. Therefore, this study aims to evaluate the effect of telenursing intervention on oral health in individuals with COPD. The experimental group will receive oral health education via telenursing intervention (via video call) and daily oral health reminders. The control group will not receive education. Oral health education for the experimental group is planned to be given within 24 hours after the pre-test. The experimental group will be invited to the hospital one month after the oral health education for evaluation of oral health and quality of life related to oral health, and the control group will be invited one month after the pre-test.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
      • Çanakkale, Turkey (Türkiye), 17100
        • Recruiting
        • Department of Nursing, Faculty of Health Sciences, Canakkale Onsekiz Mart University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • SEVDA Turen, Associate Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants must have been diagnosed with COPD for at least 6 months,
  • receive inpatient treatment in internal medicine and surgical clinics,
  • signed the informed consent form to participate in the study,
  • have internet access and a mobile device with Android/iOS operating system,
  • be able to use a phone,
  • ≥ 40 years old,
  • have no communication barriers,
  • mild (Stage 1), moderate (Stage 2), severe (Stage 3), or very severe (Stage 4) stages according to the GOLD (2023) report.

Exclusion Criteria:

  • Those diagnosed with COPD less than 6 months ago,
  • Those receiving outpatient treatment,
  • Those hospitalized in the intensive care unit,
  • Those without internet access and a mobile device with Android/iOS operating system,
  • Those who do not have the ability to use a phone,
  • Those under 40 years of age,
  • Those with communication barriers,
  • Those who wish to withdraw from the research/withdraw from participation during the research process,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: experimental group
The experimental group will receive oral health education via telenursing intervention (via video call) and daily oral health reminders. Oral health education for the experimental group is planned to be given within 24 hours after the pre-test. Participants will also receive reminders regarding oral hygiene, including "performing oral care at least twice a day, every day" and "rinsing their mouths with water after using an inhaler." The experimental group will be invited to the hospital one month after the oral health education for evaluation of oral health and quality of life related to oral health.
Behavioral: telenursing
The responsible researcher will provide oral health education to the experimental group via video call during the telenursing intervention. The content of the education will include oral health in adults; the consequences of poor oral hygiene; things to pay attention to in oral health; demonstration of toothbrushing technique; and coping with care-resistant behaviors. Participants' questions regarding oral health will be answered during the call. The oral health education session is planned to last approximately 20 minutes.
Behavioral: reminders
Participants in the experimental group will be reminded to perform oral care at least twice a day, every day, and to rinse their mouths with water after using an inhaler. They will also be reminded to schedule a face-to-face meeting one month after the education.
No Intervention: control group
The control group will not receive training. They will be invited to the hospital for an oral health and quality of life check one month after the initial follow-up.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
oral healt
Time Frame: pre-test and post-test (1 month)
The Oral Assessment Guide (ADR) will be used to evaluate oral health. The guide supports the creation of an oral care protocol for patients with impaired oral mucosal membranes. Scores on the guide range from 8 to 24. According to the ADR, a low score indicates good oral health, while a high score indicates negative changes in oral health. The oral mucosal membrane score will be evaluated in both pre-test and post-test. A light source and a tongue depressor (one for each participant) are planned to be used during the oral health assessment.
pre-test and post-test (1 month)
Quality of Life Related to Oral Health
Time Frame: pre-test and post-test (1 month)
The scale has seven sub-dimensions: 'Functional Limitation', 'Physical Pain', 'Psychological Distress', 'Physical Disability', 'Psychological Disability', 'Social Disability', and 'Handicap'. Scores obtainable from the Oral Health Impact Scale range from 0 to 56. Since all questions are in a negative form, a score close to 0 indicates good quality of life related to oral and dental health, while a score close to 56 indicates poor quality of life related to oral and dental health. A high score on the scale indicates low quality of life related to oral health.
pre-test and post-test (1 month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Çanakkale Onsekiz Mart University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: SEVDA ATEŞ, Associate Professor, Çanakkale Onsekiz Mart University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 4, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 4, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ÇOMÜ-SBF-SA-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The datasets generated and/or analysed during the current study are not publicly available due privacy reasons but are available from the corresponding author on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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