Oral Self Care Protocol and Oral Mucositis

Not Applicable

Completed

• Conditions: Mucositis Oral
• Interventions: Behavioral: oral self care protocol; Behavioral: standard care

• Registration Number: NCT06049511
• Lead Sponsor: Ege University

Brief Summary

Objective: This study was conducted in order to examine the effect of oral self-care protocol based on Orem's Self-Care Deficiency Theory on oral mucositis and self-care agency.

Method: This study was conducted as a randomized controlled trial between August 2021 and July 2022, patients with hematological malignancies receiving high-dose chemotherapy at the Izmir Ege University Faculty of Medicine Hospital and Izmir Training and Research Hospital. The sample of the study consisted of a total of 60 patients, including 30 application groups and 30 control groups, who met the inclusion criteria using the computer-based stratified randomization method. The study data were collected using "Patient Information Questionnaire," "WHO-Oral Mucositis Toxicity Scale," "Oral Assessment Guide," "Self-Care Agency Scale," "Data Collection Form Prepared According to Orem's Self-Care Deficiency Nursing Theory," "Oral Care Chart," and "Oral Cavity Photography." The oral self-care protocol, which includes training and oral care practices, was applied to the application group for 21 days from the beginning of chemotherapy treatment. The control group was not subjected to any oral care attempts by the researcher and received standard nursing care in the clinic. The data were evaluated by descriptive statistics, the Chi-square test, the Mann-Whitney U test, the Mc Ne-mar test, the Kappa compliance test, and the t test in dependent and independent groups. Keywords: chemotherapy; hematological malignancy; oral mucositis; oral self-care protocol; Orem's theory; self-care agency; nursing

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-15
• Primary Completion: 2022-07-15
• Study Completion: 2022-12-28
• Status Verified: 2023-09
• Study First Submitted: 2023-09-05
• Study First Submitted QC: 2023-09-21
• Last Update Submitted: 2023-09-21
• Study First Posted: 2023-09-22
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Willing to participate,
• Have the ability to read and write,
• Volunteer for oral cavity photography,
• Possess a platelet value above 20,000/mm3, and
• Have intact oral mucous membrane integrity.

Exclusion Criteria

• Who received combined radiotherapy and chemotherapy treatments
• Had incomplete questionnaire responses.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	oral self care protocol	An oral self-care protocol, grounded in Orem's Self-Care Deficit theory and incorporating self-care behaviors, was implemented for the patients in the treatment group. The protocol consisted of several components, including the assessment of oral mucositis by the researcher and self-assessment of the oral cavity by the patients. It also involved oral care, teaching proper tooth brushing techniques, providing written materials, supplying an oral care kit, and offering patient and family education.
control group	standard care	The control group consisted of a total of 30 patients who met the selection criteria, willingly participated in the study, and were randomly assigned based on a predetermined randomization list. In the control group, the investigator did not administer any specific oral care intervention. Instead, the patients received standard nursing care provided at the clinic to prevent oral mucositis. Moreover, all patients in the control group were given the same mouthwashes (Benzydamine and Mycostatin) as those in the treatment group. However, the frequency and timing of oral care varied among the nurses in the clinic due to differences in work load and individual experience.

Primary Outcome Measures

Name	Time	Method
World Health Organization Oral Mucositis Toxicity Scale	21 days	to assess oral mucositis severity. The World Health Organization (WHO) classifies oral mucositis into different grades: grade 0 indicates no issues with the oral mucosa; grade 1 signifies mild local changes such as erythema and inflammation, with the ability to consume oral food; grade 2 involves mild pain, along with erythema, edema, inflammation, or ulcers, allowing unrestricted eating; grade 3 denotes painful erythema, edema, or ulcers without bleeding, necessitating a liquid food diet; and grade 4 represents extensive mucositis, severe pain, and bleeding, rendering oral feeding impossible.

Secondary Outcome Measures

Name	Time	Method
Oral assessment guide	21 days	assess their oral condition on a daily basis and serves as a valuable tool for monitoring the progression of mucositis and evaluating the effectiveness of treatment. This guide encompasses eight categories: voice, swallowing, lips, tongue, saliva, mucous membranes, gums, and teeth or dentures. Each category is assigned numerical values of 1, 2, or 3, representing normal findings (1 point) to severe findings (3 points). The cumulative score for all eight categories ranges from 8 points, indicating normal findings, to 24 points, denoting severe changes. A higher score indicates an increased risk of developing mucositis.

Trial Locations

Locations (1)

Ege University Medical Faculty Hospital; 🇹🇷 İzmir, Bornova, Turkey