Effect of Black Mulberry Lollipop on Prevention of Oral Mucositis in Children
Oral Mucositis
About this trial
This is an interventional prevention trial for Oral Mucositis focused on measuring Keywords: chemotherapy, oral mucositis, black mulberry, bicarbonate, paediatric oncology
Eligibility Criteria
Inclusion Criteria:
- Being in the age group of 3-18 years
- Being hospitalised for chemotherapy treatment
- Not having oral mucositis
- No using another method to protect oral mucosa during the study period
- Not having the history of black mulberry (similar fruit berries, blackberries, etc.) allergy
- Not having intolerance to cold
Exclusion Criteria:
-Not having food in mouth
Sites / Locations
- Sağlık Bakanlığı Sapanca Ilçe Hastanesi
Arms of the Study
Arm 1
Experimental
METHOD
The power of the test in the study was calculated by using G*Power 3.1 program. While Type I error is 0.05 and the power of the test is 0.80 (α= 0.05, 1-β= 0.80), minimal sample size was calculated as 62 children (31 children in each group). By considering the losses that may occur from the sample during the study due to any reason, it was planned to include 40 children in both experimental and control groups. Follow-up lost occurred in 5 patients from experimental group and 6 patients in the control group during the study. The study was completed with 69 paediatric patients including 34 in the experimental group and 35 in the control group.