About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Oral mucositis in the first intraoral evaluation
Having diabetes
Receiving radiotherapy
Having a surgical procedure in the mouth and jaw area
Trial design
Parallel
Treatments tested in this trial
Sodium Bicarbonate Group (Usual care)
Other interventionIn 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
Other interventionThe 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
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Children's International Mucositis Evaluation Scale
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.
Oral Mucositis Evaluation Index of the World Health Organization
It is scored between zero and four points. Although there is no change in the grade-0 mucosa, grade-1 painless ulcers, erythema or mild sensitivity, grade-2 painful erythema and ulcers, solid foods can be consumed. Grade-3 painful erythema, edema or ulcer can be consumed only, grade-4 ulceration, necrosis and hemorrhage are present, the patient cannot be fed, enteral or parenteral support is required.
Secondary outcomes
Neutrophil count
The neutrophil count will be evaluated. Numbers will be recorded.
Sponsors and contacts
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