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

Burdur Mehmet Akif Ersoy University

Status

Enrolling

Conditions

Chemotherapy Effect

Oral Mucositis

Treatments

Other: Saline Group

Other: Sodium Bicarbonate Group (Usual care)

Other: Black Mulberry Syrup Group

Study type

Interventional

Funder types

Other

Identifiers

NCT06525402

2022/73

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 estimated patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

54 participants in 3 patient groups, including a placebo group

Sodium Bicarbonate Group (Usual care)

Placebo Comparator group

Description:

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.

Treatment:

Other: Sodium Bicarbonate Group (Usual care)

Saline Group

Experimental group

Description:

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

Treatment:

Other: Saline Group

Black Mulberry Syrup Group

Experimental group

Description:

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