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IRCT20200222046582N1 IRCT 2020-05-20 Mashhad University of Medical Sciences The effect of herbal mouthwash on oral mucositis in children with leukemia under chemotherapy ندارد Comparison the effect of aloe vera and honey mouthwash on oral mucositis caused by chemotherapy in children with leukemia 2020-05-21 anticipated 100 Complete https://irct.ir/trial/46163 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: In this study, the concentration / concentration in the detergents is known, Randomization description: According to the table of random numbers, a random list of numbers one to four will be created using the site www.randomization.com and using SPSS software. When sampling, each patient will be assigned the random numbers in the list, respectively, Blinding description: In order to blind people, the study of all mouthwashes used in the same and similar containers will be packaged and provided to the research units. The statistical evaluator or analyst is also aware that the samples are marked with code and the analyst is not aware of the allocation of codes to the intervention and control groups. 3 oral chemotherapy for leukemia in children with leukemia. Intervention 1: The intervention group is divided into three groups: the first group: honey mouthwash, the second group: aloe vera mouthwash, the third group: mouthwash combining aloe vera and honey).In this study, in the first group: 5% oral mouthwash,The second group: aloe vera mouthwash with a concentration of 50%, the third group: aloe vera mouthwash and honey (aloe vera with a concentration of 25% and honey with a concentration of 2.5%).All three intervention groups, during the first to fourteenth days after chemotherapy, 5 cc of mouthwash, three times daily after meals for 2 minutes in the form of spools and kept in the mouth so that all parts of the mouth, They use gums and an impregnated tongue. The patient should avoid eating and drinking for up to an hour after rinsing. Intervention 2: In the control group, the routine section (mouthwash with normal saline) will be performed. Children in the control group, during the first to fourteenth days after chemotherapy, 5 cc of mouthwash, three times a day after meals for 2 minutes in the form of pulleys and kept in the mouth so that all parts of the mouth, gums And use the impregnated tongue. The patient should avoid eating and drinking for hours after mouthwash. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is After the start of the research and its completion and the satisfaction of the participants, according to the researchers, it is not a problem to present
public Laya Rabiee
Shahrak ghar- shareate blve- shareate 39/17 st-No 24
Mashhad Iran (Islamic Republic of) 9189674496 +98 51 3662 4162 www.rabieel1@mums.ac.ir Mashhad University of Medical Sciences scientific Laya Rabiee
Shahrak ghar- shareate blve- shareate 39/17 st-No 24
Mashhad Iran (Islamic Republic of) 9189674496 +98 51 3662 4162 www.rabieel1@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Completion of written consent by the child or the child's guardian parent (based on the child's age) for the child's participation in the study Having a child has the necessary ability and cooperation to participate in the study Lack of systemic problems (kidney, liver, etc.) or other malignancies Food allergies or known allergies to aloe vera Lack of diabetes and no history of hyperglycemia The child has oral health before starting chemotherapy (no mucositis) Do not use other mouthwashes during treatment, do not use painkillers continuously, do not use antibiotics 6 years 18 years Both Children undergoing radiotherapy in addition to chemotherapy Children who refuse to continue their studies Patients with neutropenia, fever, gingivitis Teens who smoke and smoke hookah Use of steroidal anti-inflammatory drugs C81-C96 Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue Prevention Placebo The intervention group is divided into three groups: the first group: honey mouthwash, the second group: aloe vera mouthwash, the third group: mouthwash combining aloe vera and honey).In this study, in the first group: 5% oral mouthwash,The second group: aloe vera mouthwash with a concentration of 50%, the third group: aloe vera mouthwash and honey (aloe vera with a concentration of 25% and honey with a concentration of 2.5%).All three intervention groups, during the first to fourteenth days after chemotherapy, 5 cc of mouthwash, three times daily after meals for 2 minutes in the form of spools and kept in the mouth so that all parts of the mouth, They use gums and an impregnated tongue. The patient should avoid eating and drinking for up to an hour after rinsing In the control group, the routine section (mouthwash with normal saline) will be performed. Children in the control group, during the first to fourteenth days after chemotherapy, 5 cc of mouthwash, three times a day after meals for 2 minutes in the form of pulleys and kept in the mouth so that all parts of the mouth, gums And use the impregnated tongue. The patient should avoid eating and drinking for hours after mouthwash. During the first, seventh, fourteenth, twenty-first days after chemotherapy with the help of a researcher examining inflammation of the oral mucosa using the Ilers tool and the oral cavity condition using the WHO tool, aswell as the pain caused by mucositis (by the child) using the VAS tool And the question of the child who has experienced the most pain during the day? All 4 groups under study will be reviewed and recorded. Timepoint: During the first, seventh, fourteenth and twenty-first days after chemotherapy. Method of measurement: With the help of a researcher examining inflammation of the oral mucosa using the Ilers tool and the oral cavity condition using the WHO moucositis scale tool, as well as pain caused by mucositis (by the child) using the tool and Visual Analogue Scale ask the child which pain is most common during the day. Experienced? All 4 groups under study will be reviewed and recorded. Mashhad University of Medical Sciences Approved 2019-12-31 Research Ethics Committee of the Faculty of Nursing, Imamate, Mashhad University of Medical Sciences Shariati 39/17 - No. 24-West Town - Shariati St. - Shariati 39 mashhad Razavi Khorasan Iran (Islamic Republic of)