Effekt av natriumbikarbonat, saltvann og svart morbærsirup på graden av oral mukositt hos barn som får kjemoterapi
Effekten av natriumbikarbonat, saltvann og svart morbærsirup på graden av oral mukositt hos barn som får kjemoterapi: en randomisert kontrollert prøvelse
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Selda Ateş Beşirik, Assistant Professor
- Telefonnummer: +905543683323
- E-post: seldaates07@gmail.com
Studiesteder
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Isparta, Tyrkia (Türkiye)
- Rekruttering
- Isparta City Hospital
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Ta kontakt med:
- Selda Ateş Beşirik, Assistant Prof.
- Telefonnummer: +905543683323
- E-post: seldaates07@gmail.com
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Placebo komparator: 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. |
|
Eksperimentell: 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. |
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Eksperimentell: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Children's International Mucositis Evaluation Scale
Tidsramme: up to 16 days
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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
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Oral Mucositis Evaluation Index of the World Health Organization
Tidsramme: up to 16 days
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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
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Neutrophil count
Tidsramme: up to 16 days
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The neutrophil count will be evaluated. Numbers will be recorded. |
up to 16 days
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Selda Ateş Beşirik, Assistant Professor, Burdur Mehmet Akif Ersoy University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2022/73
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