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

Not Applicable

Completed

• Conditions: Oral Mucositis
• Interventions: Other: Oral Mucositis

• Registration Number: NCT04800549
• Lead Sponsor: Sapanca Ilce Devlet Hastanesi

Brief Summary

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

Detailed 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).

Study Timeline

• Study Start: 2016-02
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Study First Submitted: 2019-12-13
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-12
• Last Update Submitted: 2021-03-12
• Study First Posted: 2021-03-16
• Last Update Posted: 2021-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
METHOD	Oral Mucositis	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.

Primary Outcome Measures

Name	Time	Method
Nurse Observation Chart of Child Mucositis Evaluation	10 minute	It was prepared in parallel with Oral Mucositis Evaluation Index of the World Health Organization and formed to monitor formation or level of oral mucositis in children on the first, second, fourth, eights, sixteenth and twenty first days.
Patient Follow-up Form	3 minute	It has 16 questions prepared by the researcher utilising literature and including sociodemographic characteristic and oral care habits of the child and family.
Children's International Mucositis Evaluation Scale	2 minute	Tomlison et al. (2010) developed Children's International Mucositis Evaluation Scale (ChIMES) in order to evaluate the difficulty experienced by children with cancer due to mouth/throat pain developing depending on mucositis. Yavuz et al., (2011) conducted the validity and reliability study of the Turkish version of the scale. The scale consists of six (6) questions and it is an easy-to-apply form that can be answered with the child's facial expressions.

Trial Locations

Locations (1)

Sağlık Bakanlığı Sapanca Ilçe Hastanesi; 🇹🇷 Sakarya, Türkiye, Turkey