Effect of Sodium Bicarbonate, Saline and Black Mulberry Syrup on Degree of Oral Mucositis in Children Receiving Chemotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-30

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Oral Mucositis Chemotherapy Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will be conducted as a randomized controlled trial.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sodium Bicarbonate Group (Usual care)

General routine oral 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 will receive routine oral care in the clinic with sodium bicarbonate. It will be applied as a 5 ml mouthwash four times a day, after meals and before going to bed at night.

Group Type PLACEBO_COMPARATOR

Sodium Bicarbonate Group (Usual care)

Intervention Type OTHER

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.

Saline Group

It will be applied as a 5 ml mouthwash four times a day, after meals and before going to bed at night.

Group Type EXPERIMENTAL

Saline Group

Intervention Type OTHER

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.

Black Mulberry Syrup Group

It will be applied as a 5 ml mouthwash four times a day, after meals and before going to bed at night.

Group Type EXPERIMENTAL

Black Mulberry Syrup Group

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No