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Идёт набор NCT06525402

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

Без фазы С лечением Oral Mucositis Chemotherapy Effect

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Sodium Bicarbonate Group (Usual care), Saline Group, Black Mulberry Syrup Group.
Кому может быть актуально
Состояния в реестре: Oral Mucositis, Chemotherapy Effect. Базовые параметры: 6 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

The Effect of Sodium Bicarbonate, Saline and Black Mulberry Syrup on The Degree of Oral Mucositis in Children Receiving Chemotherapy: A Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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.
  • Другое 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.
  • Другое 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.

Первичные конечные точки

  • Children's International Mucositis Evaluation Scale [Срок оценки: up to 16 days]
  • Oral Mucositis Evaluation Index of the World Health Organization [Срок оценки: up to 16 days]
Вторичные конечные точки (1)
  • Neutrophil count [Срок оценки: up to 16 days]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Профилактика

Центры проведения

Turkey (Türkiye) · 1 центр
  • Isparta City Hospital — Isparta

Идентификаторы

NCT: NCT06525402 · 2022/73

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗