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

NCT ID: NCT04800549

Last Updated: 2021-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-02-28

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).

Conditions

Oral Mucositis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Oral Mucositis

Intervention Type: 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.

Interventions

Oral Mucositis

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Okan University

OTHER

Sponsor Role: collaborator

Sapanca Ilce Devlet Hastanesi

OTHER_GOV

Sponsor Role: lead

Responsible Party

ebru kaya

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sağlık Bakanlığı Sapanca Ilçe Hastanesi

Sakarya, Türkiye, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

SapancaH

Identifier Type: -

Identifier Source: org_study_id