The Effect of Oral Care Protocol on Prevention of Oral Mucositis in Pediatric Cancer Patients
Condition: Mucositis; Pediatric Cancer; Oral Cavity
MeSH terms: Mucositis; Stomatitis
Study type: Interventional

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.
    

Intervention name(s): Oral care protocol
Intervention type(s): Combination Product
Intervention description(s): Oral care protocol
Other intervention name(s): 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.
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomised, parallel trial design
Masking: Single (Participant)
Primary purpose: Prevention