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

Oral Mucositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04800549
• Other study ID #: SapancaH
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: February 2017

Study information

• Verified date: March 2021
• Source: Sapanca Ilce Devlet Hastanesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Saglik Bakanligi Sapanca Ilçe Hastanesi	Sakarya	Türkiye

Sponsors (2)

Lead Sponsor	Collaborator
Sapanca Ilce Devlet Hastanesi	Okan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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