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IRCT20180110038302N8 IRCT 2021-12-14 Alborz University of Medical Sciences The effect of ginger suppository on the treatment of headache and chills after spinal anesthesia Comparison of ginger suppository and placebo on headache and chills after spinal anesthesia in cesarean section patients 2022-01-21 anticipated 100 Complete https://irct.ir/trial/56984 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, a list of eligible people is prepared in Excel software. Then, the subjects are divided into two groups of intervention and control by block randomization method with 4 equal blocks, which is done with websites( www.randomization.com can do block randomization more easily). In this method, the size of all blocks is equal. In this study, with a 100 sample size, the number of blocks is 4 and the size of each block is 25. Two blocks (50 people) belong to an intervention group and two blocks (50 people) belong to the control group, Blinding description: This study is single blind. The patient does not know which drug is the main drug and which is the placebo. The intervention group is given the main drug and the control group is given the placebo. The color, smell, weight, and other characteristics of the placebo are as the same as the main drug. 3 Headache and chills after spinal anesthesia in women with cesarean section. Intervention 1: Intervention group: The main drug (ginger suppository) is given to the patient after cesarean section. A ginger suppository is given every 8 hours for the first 24 hours after cesarean section. The manufacturer of medicine is the Faculty of Pharmacy of Alborz University. This suppository is not available in the market. Intervention 2: Control group: "Placebo in the form of a ginger suppository" is given to the patient in the form of ginger suppository after cesarean section. A placebo is given as a ginger suppository every 8 hours for the first 24 hours after cesarean section. The manufacturer of medicine in the Faculty of Pharmacy of Alborz University. This suppository is not available in the market. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals. When: "Access period starts 6 months after the results are published". To whom: Our data will be available to researchers working in academic and scientific institutions, or to people who are also involved in the industry. Conditions: Receive documentation from them based on the academic degree or employment in the industry. Where to obtain: Call this phone number: 00989124195752 How to obtain: After the accuracy of the submitted documents, the data will be sent within a maximum of 2 weeks. Comments:
public Mansoureh Yazdkhasti
NO.14, Medicine school, Ooge Blvd, West BooAli Highway
Karaj Iran (Islamic Republic of) 3149969415 +98 26 3264 2815 Mansoyazd@yahoo.com Alborz University of Medical Sciences scientific Mansoureh Yazdkhasti
NO.14, Medicine school, Ooge Blvd, West BooAli Highway
Karaj Iran (Islamic Republic of) 3149969415 +98 26 3264 2815 Mansoyazd@yahoo.com Alborz University of Medical Sciences Iran (Islamic Republic of) Women aged 15 to 49 years Full-term pregnancy (37 full weeks of pregnancy) Singleton pregnancy Anesthesia class ASA I, ASA II(American Society of Anesthesiologists Physical Status Classification ) Non-emergency cesarean section Headache in the first 72 hours 15 years 49 years Female The cesarean section lasted more than an hour Attempted more than twice for spinal anesthesia Sensitivity to ginger Taking psychotropic drugs or narcotics Alcoholism O74.5 Spinal and epidural anesthesia-induced headache during labor and delivery Treatment - Other Treatment - Other Intervention group: The main drug (ginger suppository) is given to the patient after cesarean section. A ginger suppository is given every 8 hours for the first 24 hours after cesarean section. The manufacturer of medicine is the Faculty of Pharmacy of Alborz University. This suppository is not available in the market. Control group: "Placebo in the form of a ginger suppository" is given to the patient in the form of ginger suppository after cesarean section. A placebo is given as a ginger suppository every 8 hours for the first 24 hours after cesarean section. The manufacturer of medicine in the Faculty of Pharmacy of Alborz University. This suppository is not available in the market. Headache score in Visual scale of pain. Timepoint: In both groups, pain intensity will be measured at 6-time points (0.5, 1, 1.5, 3, 6, 12) hours after the operation. Method of measurement: visual scale of pain questionnaire. Shivering score in Crossley and Mahajan questionnaire. Timepoint: The severity of chills, from 20 to 95 minutes after cesarean section every 15 minutes. Method of measurement: Crossley and Mahajan questionnaire. Alborz University of Medical Sciences Approved 2020-02-17 Ethics committee of Alborz University of Medical Sciences NO.14, Medicine school, Ooge Blvd, West BooAli Highway Karaj Alborz Iran (Islamic Republic of)