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IRCT20120109008665N10 IRCT 2019-11-24 Semnan University of Medical Sciences Comparison of the effect of zingiber and acupressure on nausea and vomiting Comparison of the effect of zingiber and acupressure onchemotherapy induced nausea and vomiting (CINV) in patients with breast cancer 2019-12-22 anticipated 80 Complete https://irct.ir/trial/43703 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Assignment of samples to four groups (zingiber, acupressure, zingiber placebo and placebo of acupressure) will be done randomly using random blocks method. 10 blocks with 8 cases in each are created and every time randomly a block will be selected. In this method, A: represent zingiber group; B: acupressure; C: zingiber placebo; D: placebo of acupressure (false point). 3 Nausea and Vomiting. Intervention 1: Intervention group: All participants in Zingiber intervention group, after assuring the results of the tests, in addition to the routine interventions prescribed by the physician, receive Vomigone pills (500 mg) Produced by Dineh Pharmaceutical Company for the first day of chemotherapy, half an hour before the injection of chemotherapy drugs, and the next time, at 9 o'clock of the same day. Continue taking tablets twice a day at 9 am and 9 pm, 5 days after the completion of chemotherapy. If the patient is raised, within two hours, the drug will be re-used. Intervention 2: Intervention group: In the acupressure intervention group, in addition to the routine interventions prescribed by the physician, the acupressure wristbands will be closed in two hands for half an hour before starting the injection of drugs up to 5 days after the completion of chemotherapy in the neiguan (P6) point. Intervention 3: Control group: In the Zingiber placebo group, placebo tablets similar to Vomigone tablets (size, shape, color, taste and dosage but lacking the active ingredient) will be used. The method is similar to the Zingiber group. Intervention 4: Control group: In the acupressure placebo group, the wristbands will close on both sides of the arm on the wrist with a plastic point at the opposite point of the neiguan point (false point). The method of doing is similar to the acupressure group. 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 No more information.
public Hassan Babamohamadi
Nursing and Midwifery Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran
Semnan Iran (Islamic Republic of) 3513138111 +98 23 3365 4192 babamohammady2007@gmail.com Semnan University of Medical Sciences scientific Hassan Babamohamadi
Nursing and Midwifery Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran
Semnan Iran (Islamic Republic of) 3513138111 +98 23 3365 4192 babamohammady2007@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) Detection of breast cancer by an oncologist and pathologist Age between 18 and 70 years The normal values of hematological and biochemical laboratory values in the Zingiber group The desire to participate in the study 18 years 70 years Female Sensitivity to Zingiber and its consumption over the past week (at first use) The presence of sensitivity and ulcers or any skin problems at the site of use of acupressure wristband Use of blood diluent such as Aspirin, Warfarin, Heparin, Plavix and ... in the Zingiber group. Coagulation disorders (platelets less than 100,000/mm3, etc.) in the Zingiber group Receiving radiotherapy and chemotherapy simultaneously The diseases that lead to nausea and vomiting include liver, kidney, upper gastrointestinal cancer, acute hepatitis B, gastrointestinal obstruction, brain malignancies, high blood pressure, motion sickness, diabetes and electrolyte disorders such as hyponatremia and Hypokalemia Use of alcohol and opium The history of psychiatric problems in patients under treatment with acupressure wristband R11.2 Nausea with vomiting, unspecified Prevention Prevention Placebo Placebo Intervention group: All participants in Zingiber intervention group, after assuring the results of the tests, in addition to the routine interventions prescribed by the physician, receive Vomigone pills (500 mg) Produced by Dineh Pharmaceutical Company for the first day of chemotherapy, half an hour before the injection of chemotherapy drugs, and the next time, at 9 o'clock of the same day. Continue taking tablets twice a day at 9 am and 9 pm, 5 days after the completion of chemotherapy. If the patient is raised, within two hours, the drug will be re-used. Intervention group: In the acupressure intervention group, in addition to the routine interventions prescribed by the physician, the acupressure wristbands will be closed in two hands for half an hour before starting the injection of drugs up to 5 days after the completion of chemotherapy in the neiguan (P6) point. Control group: In the Zingiber placebo group, placebo tablets similar to Vomigone tablets (size, shape, color, taste and dosage but lacking the active ingredient) will be used. The method is similar to the Zingiber group. Control group: In the acupressure placebo group, the wristbands will close on both sides of the arm on the wrist with a plastic point at the opposite point of the neiguan point (false point). The method of doing is similar to the acupressure group. Severity of nausea and vomiting. Timepoint: Evaluation and measurements will be performed from the first day of chemotherapy up to 5 days after the completion of chemotherapy by the patient. Method of measurement: Morrow Assessment of Nausea and Emesis (MANE). Frequency of nausea and vomiting. Timepoint: Evaluation and measurements will be performed from the first day of chemotherapy up to 5 days after the completion of chemotherapy by the patient. Method of measurement: Morrow Assessment of Nausea and Emesis (MANE). Semnan University of Medical Sciences Approved 2019-12-17 Ethics committee of Semnan University of Medical Sciences Semnan University of Medical Sciences (SEMUMS), Vice Chancellor of Research and Technology , Bassij Blvd., Semnan, Iran Semnan Semnan Iran (Islamic Republic of)