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

NCT04800549 | Completed

• 1 other identifier: SapancaH
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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

Conditions

Oral Mucositis

Keywords

Keywords: chemotherapy, oral mucositis, black mulberry, bicarbonate, paediatric oncology

Outcome Measures

Primary Outcomes (3)

• Patient Follow-up Form

  It has 16 questions prepared by the researcher utilising literature and including sociodemographic characteristic and oral care habits of the child and family.

  3 minute

• Children's International Mucositis Evaluation Scale

  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.

  2 minute

• Nurse Observation Chart of Child Mucositis Evaluation

  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.

  10 minute

Study Arms (1)

METHOD

EXPERIMENTAL

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.

Other: Oral Mucositis

Interventions

Oral Mucositis OTHER

The data of the study were obtained by conducting six interviews with each child and the family. The first interview was conducted before starting to treatment on the first day of the treatment, the second interview was conducted on the 2nd day after the treatment and the following interviews were conducted on the 4th, 8th, 16th, and 21st days and in-mouth mucosa of the patient was evaluated by taking in-mouth pictures following interviewing with the child and the family. Oral care application was conducted four times a day with sodium bicarbonate solution and a lollipop made with black mulberry syrup (after meals and before going to the bed at night). Oral care was first conducted by the researcher, the oral care was then taught to the patient and patient's relatives and the application was evaluated. Figure 1 shows the study design.

METHOD

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Not having food in mouth

Sponsors & Collaborators

• Sapanca Ilce Devlet Hastanesi: lead
• Okan University: collaborator

Study Sites (1)

Sağlık Bakanlığı Sapanca Ilçe Hastanesi

Sakarya, Türkiye, 54600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: March 16, 2021
• Study Start: February 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: March 16, 2021

Record last verified: 2021-03

Locations

TU (1)