Effect of Sodium Bicarbonate, Saline and Black Mulberry Syrup on Degree of Oral Mucositis in Children Receiving Chemotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sodium Bicarbonate Group (Usual care), Saline Group, Black Mulberry Syrup Group.
- Who it may be relevant to
- Registry conditions: Oral Mucositis, Chemotherapy Effect. Basic parameters: 6 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Sodium Bicarbonate, Saline and Black Mulberry Syrup on The Degree of Oral Mucositis in Children Receiving Chemotherapy: A Randomized Controlled Trial
Overview
This study was planned as a randomized controlled experimental study in order to compare the effects of oral care with saline and black mulberry syrup in addition to sodium bicarbonate on oral mucositis level in children aged 6-18 years receiving chemotherapy.
Detailed description
Oral mucositis, also known as stomatitis, is the most common complication of cancer treatment. Mucositis affects the patient's nutrition, daily functions, and quality of life, may compromise the ability to tolerate scheduled therapy. For this reason, the children to be included in the study will be randomly divided into three groups. Sodium bicarbonate, which is the routine care in the clinic, will be administered to the control group, and to the intervention groups, saline in addition to the routine care and black mulberry syrup will be applied in addition to the routine care. Data will be collected according to Patient Information Form, International Child Mucositis Assessment Scale (ChIMES), World Health Organization Mucositis Classification and neutrophil counts. Oral care will be applied to the groups 4 times a day for 14 days. The International Child Mucositis Rating Scale (ChIMES), World Health Organization Mucositis Classification and neutrophil counts will be evaluated by the researchers on the 1st, 2nd, 4th, 8th and 16th days.
Interventions
- Other Sodium Bicarbonate Group (Usual care)
In the clinic where the research was conducted, a guideline is routinely applied for the care of oral mucositis in line with the stages of oral mucositis. Sodium bicarbonate is used in line with this guideline. The first group, the control group, will receive routine oral care in the clinic with sodium bicarbonate. Oral care will be applied 4 times a day for 14 days. - Other Saline Group
The second group, the experimental group, will first receive oral care routinely applied in the clinic. Then, oral care will be given in the form of 5 ml mouthwash with saline. Oral care will be applied 4 times a day for 14 days. - Other Black Mulberry Syrup Group
The third group, the experimental group, will first receive oral care routinely applied in the clinic. Then black mulberry syrup will be applied. Then, oral care will be given in the form of 5 ml mouthwash with black mulberry syrup. Oral care will be applied 4 times a day for 14 days.
Primary outcome measures
- Children's International Mucositis Evaluation Scale [Time frame: up to 16 days]
- Oral Mucositis Evaluation Index of the World Health Organization [Time frame: up to 16 days]
Secondary outcome measures (1)
- Neutrophil count [Time frame: up to 16 days]
Eligibility criteria
Inclusion criteria
- The willingness of the family and the child to participate in the study
- Parent and child have separately informed written consent form
- Be between 6-18 years old
- Receiving chemotherapy and being hospitalized for chemotherapy treatment
- Being fed orally
Exclusion criteria
- Oral mucositis in the first intraoral evaluation
- Having diabetes
- Receiving radiotherapy
- Having a surgical procedure in the mouth and jaw area
- Receiving steroid therapy during chemotherapy treatment
- Using a method other than the methods used in the study to protect the oral mucous membrane throughout the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Turkey (Türkiye) · 1 center
- Isparta City Hospital — Isparta
Identifiers
NCT: NCT06525402 · 2022/73