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.

Keywords

• Children
• cancer
• mucositis
• oral care
• sodium bicarbonate.

Supporting Institution

Non-Invasive Clinical Studies Ethics Committee of Dokuz Eylül University (3481GOA 2019/03-55).

Ethical Statement

This study approved by the Non-Invasive Clinical Studies Ethics Committee of Dokuz Eylül University (3481GOA 2019/03-55).

ÇOCUK KANSER HASTALARINDA AĞIZ BAKIM PROTOKOLLERİNİN MUKOZİTE ETKİSİ: RANDOMİZE KONTROLLÜ BİR ÇALIŞMA

Abstract

Amaç: Standart ağız bakım protokolleri mukozit insidansını azaltabilir. Bu çalışmada, pediatrik kanser hastalarında sodyum bikarbonat veya salin içeren "Ağız Bakım Protokolü"nün mukozit gelişimi, derecesi ve süresi üzerine etkisinin değerlendirilmesi amaçlandı. Yöntemler: Bu çalışma kör, paralel deneme tasarımına sahip, randomize kontrollü bir çalışmadır. Çocuk Hematoloji ve Onkoloji Ünitesinde üç günden fazla yatarak kemoterapi tedavisi gören hastalar (n=43) çalışmaya dahil edildi. Kontrol grubundaki hastalara (n=22) salin ile ağız bakım protokolü, çalışma grubundaki hastalara (n=21) ise sodyum bikarbonat ile ağız bakım protokolü verildi. Birincil sonuç mukozit gelişimiydi. İkincil sonuçlar mukozit derecesi, mukozit gelişimi sırasındaki hasta verileri ve mukozitin süresiydi. Çalışma ve kontrol grubundaki hastaların özellikleri ile mukoziti olan ve olmayan hastaların verileri Fisher'in kesin testi, t-testi ve ki-kare analizi ile karşılaştırıldı. Bulgular: Çalışma ve kontrol grupları arasında yaş ortalaması, cinsiyet, tanı, relaps durumu, tedavi evresi, risk grubu ve tedavi protokolleri açısından istatistiksel olarak anlamlı fark bulunamadı. Kontrol grubundaki hastaların %18,2'sinde, çalışma grubundaki hastaların ise %9,5'inde mukozit gelişti. Mukozit gelişimi, derecesi ve süresi açısından istatistiksel olarak anlamlı fark bulunamadı. Sonuç: Sodyum bikarbonat içeren ağız bakım protokolü pediatrik kanser hastalarında mukozitin önlenmesinde kullanılabilir. ClinicalTrials.gov Tanımlayıcı: NCTXXX.

Keywords

• Çocuklar
• kanser
• mukozit
• ağız bakımı
• sodyum bikarbonat.

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