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

NCT06521112 | Completed

• 1 other identifier: YS2022
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mucositis

Keywords

Intensive care unit; Oral care; Nursing; Oral mucosa; Mucositis

Outcome Measures

Primary Outcomes (3)

• 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.

  eleven days

• 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.

  eleven days

• 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.

  ten day

Study Arms (2)

Control Group

NO INTERVENTION

Individual 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 Group

EXPERIMENTAL

Morning 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.

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.

Interventions

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

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.

Also known as: KARYA

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Mucositis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• yasar sahin

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

• Ülkü Özdemir

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

• Recep Civan Yüksel

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor doctor

Model Details: a randomized, controlled trial in pre-test post-test design

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 25, 2024
• Study Start: May 27, 2023
• Primary Completion: July 12, 2023
• Study Completion: July 12, 2023
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)