Skip to main content
OpenTrials
Completed

NCT Number: NCT04800549

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Oral Mucositis Mouth Diseases Stomatitis Stomatognathic Diseases

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sağlık Bakanlığı Sapanca Ilçe Hastanesi

Sakarya, Türkiye, 54600, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Patient Follow-up Form

    Time frame: 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.

  2. Children's International Mucositis Evaluation Scale

    Time frame: 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.

  3. Nurse Observation Chart of Child Mucositis Evaluation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sapanca Ilce Devlet Hastanesi

Other Gov

Collaborators

  • Okan University

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 16, 2021
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.