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IRCT20110922007618N9 IRCT 2020-08-14 Tabriz University of Medical Sciences The effect of Zingiber officinale on healing and pain of episiotomy The effect of Zingiber officinale on healing and pain of episiotomy among primigravida women: A Randomized Controlled Trial 2020-07-21 anticipated 70 Complete https://irct.ir/trial/49394 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible individuals and volunteers are randomly divided into blocks (4 and 6 blocks) with a 1: 1 allocation ratio randomly divided into two groups: one group of ginger extract ointment (intervention group) and the other group of placebo (Control group) will be given. The amount of pain is measured with a visual pain measuring instrument and the mean wound condition score is measured by the REEDA scale. The package will be numbered in order, Blinding description: The placebo will be prepared in the form of sterile ointment and in closed tubes of both shape and color with drug packages. In addition to the person who determines the order of the individuals in the groups, the only person who will know the type of drug prescribed will be the researcher's assistant, and the participants, the researcher, the data collection and analyzer will not be informed. N/A Episiotomy. Intervention 1: Intervention group: Receive ginger extract ointment to apply the ointment to the incision every 12 hours for 10 days. Intervention 2: Control group: Apply the placebo ointment to the ointment every 12 hours for 10 days on the incision site. Yes - There is a plan to make this available What will be shared: The results of the clinical study will be published in the form of an article. When: Immediately after printing the results. To whom: All researchers. Conditions: Scientific use with reference to the article. Where to obtain: Email Dr. Soheila Bani : banis@tbzmed.ac.ir How to obtain: Maximum week after correspondence via email. Comments:
public Fatemeh Cheshfar
Tabriz School of Nursing and Midwifery, Shahnaz St.
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 banis@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Dr. Soheila Bani
Tabriz School of Nursing and Midwifery, Shahnaz St.
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 banis@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Primiparous women The lack of drug and psychotropic Age range 35-18 years Birth of a live, single fetus Do not use any special medicine(such as anti-inflammatory drugs other than acetaminophen and coagulation based on the patient's statements) history of impaired wound healing disease, like systemic disease, cardiac, renal, pulmonary, coagulation disorders, immune deficiency, connective tissue disorders, diabetes,haemophilia Failure to follow the special diet No anemia during pregnancy The lack of early PPH No history of prenatal vaginal examinations and manipulations extent or large episiotomy (repair length 4-3 cm) Willingness and possibility for the mother to visit Al-Zahra Hospital on days 5 and 10 No history of reconstructive surgery on the vagina and intercostals (according to the woman) Lack of long-term rupture of the amniotic sac (more than 18 hours) Do not use blood pressure medications (mothers with high blood pressure and preeclampsia) Do not use topical lidocaine cream Do not use mopericin Do not use curettage in mothers 18 years 35 years Female Unwillingness to participate in the study O90.1 Disruption of perineal obstetric wound Treatment - Drugs Placebo Intervention group: Receive ginger extract ointment to apply the ointment to the incision every 12 hours for 10 days. Control group: Apply the placebo ointment to the ointment every 12 hours for 10 days on the incision site. Episiotomy wound healing. Timepoint: Before intervention,12 hours after delivery and on days 5 and 15. Method of measurement: Epidatomic wound healing scale; REEDA (Redness, Edema, Ecchymosis, Discharge, Approximation). The severity of episiotomy pain. Timepoint: Before intervention,12 hours after delivery and 5 and 15 days later. Method of measurement: Visual Pain Scale (vas). Count the acetaminophen pills used. Timepoint: Fifteenth day after delivery. Method of measurement: Counting tablets. The frequency of side effects in the group receiving ginger extract ointment ginger and placebo. Timepoint: Fifteenth day after delivery. Method of measurement: Questionnaire. Tabriz University of Medical Sciences Approved 2020-06-30 Research deputy, Tabriz University of Medical Sciences Golgasht St. - Tabriz University of Medical Sciences - Central Building No. 2 Floor 3 - Research Deputy Tabriz East Azarbaijan Iran (Islamic Republic of)