The Effect of Oral Care Protocol on Prevention of Oral Mucositis in Pediatric Cancer Patients

Dokuz Eylül University (DEU)

Status: Completed

Conditions: Pediatric Cancer; Oral Cavity; Mucositis

Treatments: Combination Product: Oral care protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT04586491

Gülçin Özalp Gerçeker

Details and patient eligibility

About

This study conducted to determine the effects of two oral care protocols containing sodium bicarbonate or saline solution in the prevention of oral mucositis (OM), mucositis degree, and recovery time in children with cancer.

Full description

The study conducted as a randomized controlled trial with a parallel design with two groups; Study group/ Oral care protocol with saline solution Control group/ Oral care protocol with sodium bicarbonate solution

Study Hypothesis; There is a difference in oral mucositis (OM) between groups. There is a difference in the degree of OM between groups. There is a difference in the OM recovery time between groups. There is a difference in demographic variables in patients with and without mucositis.

The study sample was comprised of 43 children with cancer aged 1-17 years, received chemotherapy for ≥3 days at inpatient clinics, and whose families agreed to their participation in the study. Patients excluded who have oral ulceration or mucositis, taking any antiviral or antifungal therapy for OM before enrollment in the study. This trial was a triple blinded which the patients/parents, nurses, and the investigators have no idea about the groups.

In the study, patients were allocated by the blocked randomization. After naturally separating the gender variable into 2 layers, the age was divided into 5 layers as "<1 year, 1-3 years,>3-6 years, 6-12 years,>12 years", and the diagnosis variable was divided into 3 layers as "ALL, AML and oncological tumors."

Socio-Demographic Data Collection Form, International Child Mucositis Rating Scale (CHIMES), and Mucositis Follow-up Form used.

The child who do not have mucositis and who will be hospitalized for more than 3 days for chemotherapy will be distributed to the groups by stratified randomization method, the information of the patients will be obtained with the sociodemographic data collection form, oral care training will be given to the patient and the family, oral care protocol will be applied and it will be evaluated daily with the CHIMES and Mucositis Follow-up Form, and the severity of mucositis according to the World Health Organization Mucositis Assessment Index, the mean score of the CHIMES, recovery time will be monitored through the Mucositis Follow-up Form.

Enrollment: 40 patients

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• have cancer, aged 1-17 years, received chemotherapy for ≥3 days at inpatient clinics and whose families agreed to their participation in the study.

Exclusion criteria

• who have oral ulceration or mucositis, in terminal period, taking any antiviral or antifungal therapy for OM before enrollment in the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Study group/ Oral care protocol with saline solution

Experimental group

Description:

All patients took oral care protocol in the unit with saline solution

Treatment:

Combination Product: Oral care protocol

Control group/ Oral care protocol with sodium bicarbonate solution

Experimental group

Description:

All patients took oral care protocol in the unit with sodium bicarbonate solution

Treatment:

Combination Product: Oral care protocol