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MucositisNCT06521112

The Effect of Oral Care on Mucositis and Oral Mucosa According to Individual Oral Care Frequency Assessment

A study testing Oral care with a solution containing 0.2% chlorhexidine gluconate a frequency determined according to the results of the Intensive Care Oral Care Frequency Rating Scale. in people with Mucositis, run by TC Erciyes University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to examine the effect of oral care based on individual oral care frequency assessment on mucositis and oral mucosa integrity in intensive care patients, instead of standard routine oral care practice. The study was planned as a randomized controlled experimental study. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mucositis
What is being tested?
Oral care with a solution containing 0.2% chlorhexidine gluconate a frequency determined according to the results of the Intensive Care Oral Care Frequency Rating Scale.
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteTurkey (Türkiye)
Study dates
27 May 2023to 12 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 18 and over,
  • Patients in the Internal Medicine Intensive Care Unit,
  • According to the World Health Organization Mucositis Evaluation Form, patients who do not have mucositis and patients who have mucositis but do not require additional treatment,
  • Conscious patients/relatives of unconscious patients who agreed to participate in the study and whose voluntary consent was obtained,
  • Patients who are not allergic to the oral care solution or mouthwash ingredients to be used will be included in the study.

Who cannot join

  • Patients under the age of 18,
  • Patients who do not accept the study,
  • Patients who are allergic to the oral care solution or mouthwash ingredients to be used,
  • Patient groups who have operations in the mouth and for whom oral care is contraindicated,
  • Patients with head and neck cancer receiving radiotherapy will not be included in the study.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Erciyes University

    Kayseri, 38039

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Oral Care on Mucositis and Oral Mucosa in Intensive Care Unit Patients According to Individual Oral Care Frequency Assessment

The aim of the study is to examine the effect of oral care based on individual oral care frequency assessment on mucositis and oral mucosa integrity in intensive care patients, instead of standard routine oral care practice.

The study was planned as a randomized controlled experimental study. The population of the research consists of patients hospitalized in the Internal Medicine Intensive Care Unit of Erciyes University Health Application and Research Center in Kayseri. In determining the groups, randomization was planned to be determined by lottery method, and patients were assigned to groups with odd and even bed numbers accordingly. In the study, data were collected using the Patient Information Form, Intensive Care Oral Care Frequency Assessment Scale, World Health Organization Mucositis Evaluation Form and Patient Follow-up Form.

Read the detailed description

The research was conducted as a randomized, observational drug study to examine the effect of oral care based on individual oral care frequency assessment on mucositis and oral mucosal integrity in intensive care patients, instead of standard oral care practice. Intervention and control groups were used in the study. While performing oral care, which forms the basis of the study, support was received from intensive care nurses with experience in accordance with the procedure steps.

The population of the research consists of patients hospitalized in the Internal Medicine Intensive Care Unit of Erciyes University Health Application and Research Center.

For the sample size, 21-20 patients were included in the control and intervention groups, respectively, between May 2023 and December 2023.

In the assignment of groups, randomization was planned to be determined by lottery method, and accordingly, patients were assigned to groups with odd bed numbers and even bed numbers. From time to time, patient beds were closed (due to lack of personnel) and no patient admissions could be made. In this case, there could be differences in the characteristics of the patients who could be admitted to each bed. Equivalence of the groups in terms of age, gender and disease characteristics was ensured by randomization.

Applications to the Intervention Group Patients in the intervention group were administered the Patient Information Form, Intensive Care Oral Care Frequency Evaluation Scale, World Health Organization Mucositis Evaluation Form and Oral Evaluation Guide on the first day. Oral care frequency was planned according to the results of the oral care frequency assessment scale. The measurements taken and the planned oral care frequency were recorded in the patient follow-up form. Then, oral care was given at the planned frequency in line with the clinical protocol and according to the results of the Oral Care Frequency Evaluation Scale. Oral care starts with creating a suitable environment; The patient's mouth care swabs were prepared by wetting them with a solution (containing 0.2% chlorhexidine gluconate) for each application, 4 equal to each patient. If the patient was conscious, he was given a comfortable position. If he was not conscious, the patient's head was turned towards the person who will perform the procedure. The patient was kept in a side-lying position, and oral care was given to the patient, covering the patient's teeth, inner cheeks, sublingual, gums and all other soft tissues. After the patient's oral care procedure was completed, the procedure was terminated by giving the patient his previous position. Each treatment lasted no less than 2 minutes (min.).

Then, the Intensive Care Oral Frequency Evaluation Scale, World Health Organization Mucositis Evaluation Form and Oral Evaluation Guide were applied every morning shift for 10 days, and daily oral care frequency was planned according to the results of the oral care frequency evaluation scale. The measurements taken and the planned oral care frequency were recorded in the patient follow-up form. Then, oral care was given in accordance with the clinical protocol and at the determined frequency.

After the tenth day was completed, the World Health Organization Mucositis Evaluation Form and Oral Evaluation Guide were applied again.

Oral care will be performed with the solution currently used by the clinic, and existing application solutions will not be interfered with. The study was terminated for patients whose oral care solutions were changed during the study.

Applications to the Control Group Patients in the control group were administered the Patient Information Form, World Health Organization Mucositis Evaluation Form and Oral Evaluation Guide on the first day. Then, oral care was given at the frequency of the clinic's routine and in line with the clinic protocol. The daily oral care routine of the clinic was applied once per shift (there are 3 shifts in total; 08:00-16:00; 16:00-24:00; 24:00-08:00) as a standard. Oral care starts with creating a suitable environment; The patient's mouth care swabs were prepared by wetting them with a solution (containing 0.2% chlorhexidine gluconate) for each application, 4 equal to each patient. If the patient was conscious, he was given a comfortable position. If he was not conscious, the patient's head was turned towards the person who will perform the procedure. The patient was kept in a side-lying position, and oral care was given to the patient, covering the patient's teeth, inner cheeks, sublingual, gums and all other soft tissues. After the patient's oral care procedure was completed, the procedure was terminated by giving the patient his previous position. Each treatment lasted no less than 2 minutes (min.).

Then, the World Health Organization Mucositis Evaluation Form and Oral Evaluation Guide were applied every morning shift for 10 days, and the measurements and the routine oral care frequency of the clinic were recorded on the patient follow-up form. Then, oral care was given at the clinic's routine frequency and in line with the clinic protocol.

After the tenth day was completed, the World Health Organization Mucositis Evaluation Form and Oral Evaluation Guide were again in compliance.

Oral care will be performed with the solutions currently used by the clinic, and existing application solutions will not be interfered with. The study was terminated for patients whose oral care solutions were changed during the study.

The suitability of the data for normal distribution was evaluated with histogram, Q-Q graphs and Shapiro-wilk test. Homogeneity of variance was tested with the Levene test. In comparisons between groups, independent two-sample t-test was applied for quantitative variables. One-way analysis of variance was used for comparisons between more than two groups. Paired t test was used for quantitative variables in repeated pairwise comparisons. . Comparisons between more than two repeated measurements were evaluated by analysis of variance in repeated measurements. Pearson χ2 analysis and Fisher exact χ2 test were used for comparisons of categorical data. Bonferroni, Tukey and Tamhane tests were applied for multiple comparisons. The significance level was accepted as p<0.05.

Ethics committee approval (decision no: 2022/751) from the Erciyes University Clinical Research Ethics Committee and written permission from the unit where the study would be conducted were obtained in order to conduct the study. In addition, those whose written consent was obtained through the Informed Consent Form were included in the study.

Conditions
Mucositis
Being tested
Oral care with a solution containing 0.2% chlorhexidine gluconate a frequency determined according to the results of the Intensive Care Oral Care Frequency Rating Scale.
Keywords
Intensive care unit, Oral care, Nursing, Oral mucosa, Mucositis
Medical subject headings
Mucositis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral care with a solution containing 0.2% chlorhexidine gluconate a frequency determined according to the results of the Intensive Care Oral Care Frequency Rating Scale.Drug

    Also called KARYA

    Every day for 10 days, Frequency determined according to Intensive Care Oral Care Frequency Rating Scale, Oral care was applied for 2 minutes a solution containing 0.2% chlorhexidine gluconate.

Study groups in NCT06521112
Study groupRoleWhat they receive
Control GroupNo interventionIndividual daily oral care frequency will not be determined for each patient in the control group. 0.2% chlorhexidine for 2 minutes, once per shift as frequently as the clinic routinely applies (3 shifts in total: once between 08:00-16:00; 16:00-24:00; 24:00-08:00) standard oral care will be applied with the solution containing.
Intervention GroupExperimentalMorning shift every day for 10 days; An individual Intensive Care Oral Care Frequency Rating Scale will be applied to each patient daily. According to the results of the Intensive Care Oral Care Frequency Evaluation Scale, individual oral care frequency will be planned for each patient daily and recorded in the patient follow-up form. Then, oral care will be applied with a solution containing 0.2% chlorhexidine gluconate for 2 minutes, in line with the clinical protocol and at the planned frequency.
Receives: Drug: Oral care with a solution containing 0.2% chlorhexidine gluconate a frequency determined according to the results of the Intensive Care Oral Care Frequency Rating Scale.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. World Health Organization Mucositis Evaluation Form

    World Health Organization Oral Mucositis Evaluation Form is used in healthcare institutions to evaluate the oral mucosa and determine the degree of oral mucositis. . According to this form, mucositis degrees are scored between 0 and 4 points. While performing this scoring, the oral mucosa of individuals is evaluated both objectively (erythema, ulceration, etc.), subjectively (oral pain, etc.) and functionally (patient's ability to eat, etc.). These ratings; 0: no oral mucositis; 1 point is mild; 2 points is medium; 3 points are serious; A score of 4 indicates the presence of life-threatening mucositis.

    Measured: eleven days

  2. Oral Evaluation Guide

    The Oral Evaluation Guide, which is a frequently used guide in our country, was created by Eilers et al. in 1988. The guide consists of 8 headings. The titles are examined to provide information about individuals' oral and dental health. These titles; condition of voice, swallowing, lips, tongue, saliva, mucous membranes, gums, teeth or dentures. Each variable is prepared to receive 1, 2 or 3 points, and the dialect evaluation score is obtained by summing these points. A minimum of 8 and a maximum of 24 points can be obtained in the guide. In line with the guide, low scores indicate that the oral mucosa health is good, while high scores indicate that the oral mucosal health is poor.

    Measured: eleven days

  3. Intensive Care Oral Care Frequency Rating Scale

    The scale includes nine parameters. These; It consists of the following topics: age, lips, teeth, tongue, oral mucosa, saliva, cheeks, nutritional support and respiratory support. Each parameter is evaluated separately as Normal = 1 point, Mild = 2 points, Moderate = 3 points and Severe = 4 points. In cases of broad-spectrum antibiotic or steroid treatment, diabetes mellitus diagnosis, low hemoglobin (Hb) concentration and immunosuppressive drug use, 1 additional point is added to the total score for each condition. According to the total score, the patient's oral care frequency is revealed.

    Measured: ten day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2024
  2. Study start27 May 2023
  3. Primary completion12 Jul 2023
  4. Study completion12 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
a randomized, controlled trial in pre-test post-test design
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06521112
Sponsor's protocol ID
YS2022
Status last verified
Jul 2024
First submitted
8 Jul 2024
Last updated
25 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Oral care with a solution containing 0.2% chlorhexidine gluconate a frequency determined according to the results of the Intensive Care Oral Care Frequency Rating Scale. in people with Mucositis, run by TC Erciyes University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

World Health Organization Mucositis Evaluation Form (time frame: eleven days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.

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