Effekt av natriumbikarbonat, koksaltlösning och svart mullbärssirap på graden av oral mukosit hos barn som får kemoterapi
Effekten av natriumbikarbonat, koksaltlösning och svart mullbärssirap på graden av oral mukosit hos barn som får kemoterapi: en randomiserad kontrollerad studie
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Selda Ateş Beşirik, Assistant Professor
- Telefonnummer: +905543683323
- E-post: seldaates07@gmail.com
Studieorter
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-
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Isparta, Turkiet (Türkiye)
- Rekrytering
- Isparta City Hospital
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Kontakt:
- Selda Ateş Beşirik, Assistant Prof.
- Telefonnummer: +905543683323
- E-post: seldaates07@gmail.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Placebo-jämförare: 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. |
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. |
|
Experimentell: Saline Group
It will be applied as a 5 ml mouthwash four times a day, after meals and before going to bed at night. |
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. |
|
Experimentell: 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. |
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Children's International Mucositis Evaluation Scale
Tidsram: up to 16 days
|
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. |
up to 16 days
|
|
Oral Mucositis Evaluation Index of the World Health Organization
Tidsram: up to 16 days
|
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. |
up to 16 days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Neutrophil count
Tidsram: up to 16 days
|
The neutrophil count will be evaluated. Numbers will be recorded. |
up to 16 days
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Selda Ateş Beşirik, Assistant Professor, Burdur Mehmet Akif Ersoy University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2022/73
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