- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07462208
Oral Health Intervention in Hemodialysis Patients
March 10, 2026 updated by: Sevda Ateş, Çanakkale Onsekiz Mart University
The Effect of Oral Care Education and Reminder Cards on Patients Receiving Hemodialysis Treatment: A Quasi-experimental Study
Preserving dental health in patients undergoing hemodialysis is crucial for enhancing quality of life.
Nonetheless, interventions pertaining to oral health have not been adequately studied.
The impact of a simultaneous intervention comprising oral health education and reminder cards remains ambiguous.
The findings help to examine the effect of oral health interventions on the levels of oral health and chronic disease adherence in patients receiving hemodialysis treatment.
The use of oral care education, reminder cards, and checklists related to oral health can prevent the neglect of oral care.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Preserving dental health in patients undergoing hemodialysis is crucial for enhancing quality of life.
Nonetheless, interventions pertaining to oral health have not been adequately studied.
The aim is to investigate the impact of oral care education and reminder cards concerning oral health on the oral health and illness adaptation of persons undergoing hemodialysis.
The study employed a quasi-experimental design with a single group, utilising pre-test and post-test measurements.
The study included 82 individuals (aged ≥ 18 years) receiving treatment in the hemodialysis units of two different hospitals in Turkey.
Sociodemographic and clinical information was obtained from medical records.
The "Adaptation to Chronic Illness Scale" and the "Oral Assessment Guide" were employed to assess oral health and illness adaptation.
A one-week intervention was conducted, using daily oral health reminder cards following oral care teaching.
A significant difference was found between the mean oral health and illness adaptation levels in the pre-test (15.51±2.67;
84.37±9.14, respectively) and post-test (12.61±3.83;
86.26±9.66,
respectively) scores (p=0.00).
Oral health and treatment adherence were better after the use of oral care education and reminder cards (p=0.00).
Daily tooth brushing frequency was a common factor influencing oral health and chronic disease adherence levels (p<0.05).
The mean scores for oral health and illness adaptation were moderately and negatively correlated before and after the intervention (sırasıyla r=-0.46,
r=-0.52;
p<0.01).
The findings help to examine the effect of oral health interventions on the levels of oral health and chronic disease adherence in patients receiving hemodialysis treatment.
The use of oral care education, reminder cards, and checklists related to oral health can prevent the neglect of oral care.
Study Type
Observational
Enrollment (Actual)
82
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Çanakkale, Turkey (Türkiye), 17100
- Department of Nursing, Faculty of Health Sciences, Canakkale Onsekiz Mart University
-
-
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The population consisted of 115 individuals who applied to the hemodialysis unit of a research and practice hospital located in a city centre for hemodialysis treatment between July and October 2024.
No sample selection was performed, and 82 (71.30%) patients on hemodialysis who met the inclusion criteria of the research were included in the sample.
Description
Inclusion Criteria:
- being 18 years of age or older,
- receiving HD treatment three or four times a week for at least 6 months,
- having no hearing, visual, or speech impairment,
- having no diagnosis of malignancy,
- performing self-oral care,
Exclusion Criteria:
- Patients who refused to participate in the study,
- did not meet the inclusion criteria,
- did not consent to an oral examination,
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
experimental group
Experimental: arm description experimental Arm Description: The socio-demographic and descriptive characteristics and disease adaptation levels included in the survey form were answered through face-to-face interviews.
Participants' oral health was assessed.
Oral care education was provided.
Disease adaptation levels and oral health were assessed one week after the education.
|
After the pre-test application, one-on-one oral care education, lasting an average of 15 minutes, was conducted for each participant.
The content of the education included: oral health in adults; the consequences of poor oral hygiene; points to consider for oral health; demonstration of the brushing technique; coping with care-resistant behaviors; and how to use the oral health reminder card and checklist.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oral Assessment Guide
Time Frame: one weeks
|
The guide allows for the assessment of voice, swallowing, lips, tongue, saliva, mucous membrane, gums, and teeth/dentures.
The OAG supports the creation of an oral care protocol for patients with impaired oral mucous membranes.
Each change related to oral health is scored between 1 and 3 points, and these scores are summed to obtain the total score.
Scores obtainable from the OAG range from 8 to 24.
A score between 8 and 14 indicates a "risk of impairment in the oral mucous membrane," while a score between 14 and 24 indicates "impairment in the oral mucous membrane."
According to the OAG, a low score indicates good oral health, whereas high scores suggest poor oral health.
A light source and a tongue depressor for each participant were used when evaluating oral health.
|
one weeks
|
|
Oral Health Reminder Card
Time Frame: one weeks
|
The card contains a total of 10 items regarding what should be paid attention to in daily oral health and was prepared based on the literature.
The reminder cards were 10x15 cm in size, and participants were asked to place these cards somewhere visible in their homes.
The reminder cards were not taken back.
|
one weeks
|
|
Oral Health Checklist
Time Frame: one weeks
|
This form contains the items listed on the Oral Health Reminder Card.
Participants were asked to implement the items on the checklist and mark them as applied.
Participants had the opportunity to evaluate whether they performed the oral health items every day over a one-week period.
|
one weeks
|
|
Adaptation to Chronic Illness Scale
Time Frame: one weeks
|
The scale comprises 25 items across three subdomains, including physical, social, and psychological adjustment.
The scale is designed as a 5-point Likert scale (with 1 = Strongly Disagree and 5 = Completely Agree).
Items 5, 6, 12, 17, 19, 20, 24, and 25 are reverse scored.
Maximum score that can be obtained from the scale is 125.
Higher scores from the subdomains or the entire scale are indicative of the fact that the patients' level of adaptation to the disease is also high.
The Cronbach's Alpha value of the scale is 0.88 for the entire scale.
|
one weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: SEVDA ATEŞ, Associate Professor, Canakkale 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 (Actual)
June 3, 2024
Primary Completion (Actual)
July 3, 2024
Study Completion (Actual)
October 3, 2024
Study Registration Dates
First Submitted
March 5, 2026
First Submitted That Met QC Criteria
March 5, 2026
First Posted (Actual)
March 10, 2026
Study Record Updates
Last Update Posted (Actual)
March 12, 2026
Last Update Submitted That Met QC Criteria
March 10, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- COMU-SBF-SA-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Because patient data should not be shared during the ethics committee approval process.
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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