Effect of Black Mulberry Lollipop on Prevention of Oral Mucositis in Children

Sapanca Ilce Devlet Hastanesi

Status: Completed

Conditions: Oral Mucositis

Treatments: Other: Oral Mucositis

Study type: Interventional

Funder types: Other

Identifiers

NCT04800549

SapancaH

Details and patient eligibility

About

THE EFFECT OF BLACK MULBERRY LOLLIPOP AND SODIUM BICARBONATE USED IN ORAL CARE ON PREVENTION OF ORAL MUCOSITIS AMONG CHILDREN RECEIVING CHEMOTHERAPY DUE TO CANCER

Full description

The study was conducted experimentally to determine the effect of black mulberry lollipop and sodium bicarbonate used in oral care on prevention of oral mucositis in children followed up due to the diagnosis of cancer. Sodium bicarbonate and black mulberry treatment were compared to prevent oral mucositis in 69 children receiving chemotherapy due to cancer. While 35 children were assigned to the experimental group (sodium bicarbonate + black mulberry lollipop application), 34 were assigned to the control group (sodium bicarbonate application).

Enrollment: 69 patients

Sex: All

Ages: 3 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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69 participants in 1 patient group

METHOD

Experimental group

Description:

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.

Treatment:

Other: Oral Mucositis