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

NCT ID: NCT04586491

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-07
• Study Completion Date: 2020-02-10

Brief Summary

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.

Detailed 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.

Conditions

Mucositis; Pediatric Cancer; Oral Cavity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Study group/ Oral care protocol with saline solution

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

Group Type: EXPERIMENTAL

Oral care protocol

Intervention Type: COMBINATION_PRODUCT

Oral care protocol

Control group/ Oral care protocol with sodium bicarbonate solution

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

Group Type: EXPERIMENTAL

Oral care protocol

Intervention Type: COMBINATION_PRODUCT

Oral care protocol

Interventions

Oral care protocol

Oral care protocol

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Daily evaluation of the inside of the mouth with the ChIMES; Gargle with solution; wiping the inside of the mouth with solution and sterile sponge; Brushing teeth with a soft toothbrush if platelet value was > 50000mm3.; Training for the child and family in oral care.

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dokuz Eylul University

OTHER

Sponsor Role: lead

Responsible Party

Gülçin Özalp Gerçeker

Dokuz Eylul University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gülçin Özalp Gerçeker

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Gülçin Özalp Gerçeker

Identifier Type: -

Identifier Source: org_study_id