The Effect of Oral Care Protocols on Mucositis in Pediatric Cancer Patients: A Randomized Controlled Trial

Abstract

Background/Aims: Standard oral care protocols can reduce the incidence of mucositis. This study aimed to evaluate the effect of the "Oral Care Protocol" containing sodium bicarbonate or saline on mucositis development, degree, and duration in pediatric cancer patients. Methods: This study is a blind, parallel trial design, randomized controlled study. Patients (n = 43) who received inpatient chemotherapy treatment for more than three days at the Pediatric Hematology and Oncology Unit were included. The oral care protocol with saline was given to the patients in the control group (n = 22), and the oral care protocol with sodium bicarbonate was given to the patients in the study group (n = 21). The primary outcome was the development of mucositis. The secondary outcomes were mucositis degree, patient data at the time of mucositis development, and the duration of mucositis. The characteristics of the patients in the study and control groups and the data of patients with and without mucositis were compared with Fisher's exact test, t-test, and chi-square analysis. Results: No statistically significant difference was found between the study and control groups in terms of mean age, gender, diagnosis, relapse status, treatment stage, risk group, and treatment protocols. Mucositis developed in 18.2% of the patients in the control group and 9.5% of the patients in the study group. No statistically significant difference was found in terms of mucositis development, degree, and duration. Conclusions: The oral care protocol with sodium bicarbonate can be used to prevent mucositis in pediatric cancer patients. ClinicalTrials.gov Identifier: NCTXXX.