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IRCT20171002036505N2 IRCT 2021-04-26 Zahedan University of Medical Sciences The effect of Salvadora persica stick (miswak) and Persica mouthwash solution on the severity and pain of stomatitis in patients undergoing chemotherapy. Comparison of the effect of Salvadora persica stick (miswak) and Persica mouthwash solution on the severity of stomatitis and its pain in patients undergoing chemotherapy for Breast Cancer. 2021-10-23 anticipated 75 Complete https://irct.ir/trial/55404 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients who meet the inclusion criteria will be by random allocation method and using dice (Roll of a dice),will be assigned to three groups: toothbrush stick (25 people), Persica mouthwash (25 people) and control (25 people). Numbers 1 and 2 will be considered for the toothbrush stick group, numbers 3 and 4 will be considered for the Persica mouthwash group and numbers 5 and 6 will be considered for the control group, Blinding description: 1. The person who evaluates the mouth of the patients participating in the study is blind. Thus, the mouth evaluation of patients in terms of incidence and severity of stomatitis will be performed by a study colleague who is unaware of the patient group, and the result is coded in the checklist of each group (patients in the Salvadora persica stick intervention group). Will register with M code and Persica mouthwash solution group with P code and control group with C code. 2. The statistical consultant in charge of data analysis will be unaware of the intervention groups; The data will be entered by the researcher with codes M, P, C in SPSS and will be provided to the statistical consultant for analysis. N/A Condition 1: stomatitis. Condition 2: breast cancer. Intervention 1: Intervention group 1: After moistening the toothbrush stick with cold boiled water for 15 minutes, patients move the toothbrush stick like a normal toothbrush, on the inner, outer and chewing surfaces of the teeth for 5 minutes three times a day (after each meal) and refrain from eating for up to an hour. Intervention 2: Intervention group 2: Patients will brush their teeth three times a day (after each meal) with a soft toothbrush and toothpaste for children, followed by using 15 drops of Persica mouthwash diluted with 15 cc teeth for half to one minute and taking it out and refraining from eating for an hour. Intervention 3: Control group: Patients will not receive any intervention and will perform routine care. 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 The data will only be made available to the Research Vice Chancellor for funding support if necessary
public Zahra Pishkar Mofrad
Mashahir square.School of Nursing & Midwifery
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3344 2481 pishkarz@gmail.com Zahedan University of Medical Sciences scientific Zahra Pishkar Mofrad
میدان دکتر حسابی، پردیس علوم پزشکی
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3337 2151 Moya.2471@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) The definitive diagnosis of breast cancer The first session of chemotherapy Age range of 20-60 years Having natural teeth, no oral malformations, and oral mucosal health at the time of study Consent to participate in the study 20 years 60 years Both Use of analgesics, antibiotics, and other mouthwash solution Addiction to drugs and smoking History of sensitivity to specific substance, allergic rhinitis, and dermatitis Underlying diseases (diabetes mellitus, hepatitis, liver and kidney disorders, and gastrointestinal diseases) Concomitant treatments such as radiation therapy K12 C50 ICD-10-CM Code K12 - Stomatitis and related lesions ICD-10-CM Code C50-Malignant neoplasm of breast Prevention Prevention Prevention Intervention group 1: After moistening the toothbrush stick with cold boiled water for 15 minutes, patients move the toothbrush stick like a normal toothbrush, on the inner, outer and chewing surfaces of the teeth for 5 minutes three times a day (after each meal) and refrain from eating for up to an hour. Intervention group 2: Patients will brush their teeth three times a day (after each meal) with a soft toothbrush and toothpaste for children, followed by using 15 drops of Persica mouthwash diluted with 15 cc teeth for half to one minute and taking it out and refraining from eating for an hour. Control group: Patients will not receive any intervention and will perform routine care. Stomatitis. Timepoint: 7 and 14 days after the intervention. Method of measurement: World Health Organization (WHO) scale for oral mucositis. Pain. Timepoint: 7 and 14 days after the intervention. Method of measurement: Visual Analog Scale for Pain. Zahedan University of Medical Sciences Approved 2021-02-01 Ethics committee of Zahedan University of Medical Sciences Campus of Medical Sciences, Dr. Hesabi Squ Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)