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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorBurdur Mehmet Akif Ersoy University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Sodium Bicarbonate Group (Usual care)

    Other intervention

    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

    Other intervention

    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

    Other intervention

    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.

Treatment groups

54 Participants
are divided into 3 treatment groups
Group A: Sodium Bicarbonate Group (Usual care)Placebo comparator 1 intervention
Group B: Saline GroupExperimental treatment 1 intervention
Group C: Black Mulberry Syrup GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
up to 16 days
2

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.

Time frame
up to 16 days

Secondary outcomes

1

Neutrophil count

The neutrophil count will be evaluated. Numbers will be recorded.

Time frame
up to 16 days

Other outcomes

Sponsors and contacts

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