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IRCT20181110041603N1 IRCT 2019-08-10 Shahid Beheshti University of Medical Sciences Effect of Silybum marianum ointment on wound healing and episiotomy pain in primiparous women Evaluation the effect of Silybum marianum ointment on episiotomy wound healing and pain intesity in primiparous women. 2019-08-05 anticipated 90 Complete https://irct.ir/trial/39499 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Randomization description: Random numbers will be used to randomize and assign individuals to groups; the randomization using Excel software is as follows: First, in a column, the groups are entered as A, B, and below, since the number of samples in each group is 45 (including sample loss), therefore, 45, B, A should be repeatedly and regularly be. In the opposite column, random numbers are generated using the RAND command. In the next step, using the order command, random numbers are generated from small to large or vice versa, which makes the order of groups A, B change. By using the new order, people are assigned to different groups, Blinding description: Blind technique will be double-blind, and the investigator and none of the patients will be aware of the type of medication. The drugs are labeled with A, B, C and D labels and given to patients. To conceal the allocation of individuals, the drugs are numbered in the same boxes, depending on the order of allocation. Interventions are stored in closed packet envelopes and are periodically numbered. To hide the allocation of individuals, envelopes are rotated periodically and only after the name and other characteristics of the participant are written on the appropriate envelope. 3 Episiotomy. Intervention 1: Intervention group: Silybum marianum ointment (produced in Shahid Beheshti pharmacy faculty) uses topically one finger amount (2cm) on episiotomy wounds twice for 10 days. Intervention 2: Control group: ; placebo ointment (produced in Shahid Beheshti pharmacy faculty) uses topically one finger amount (2cm) on episiotomy wounds twice for 10 days. 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 Dr Sepideh Hajian
School of Nursing and Midwifery, Niayesh Highway, Valiasr St, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5366 s.hajian@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Dr Sepideh Hajian
chool of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5366 s.hajian@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Being primiparous Aged between 18 to 35 years. BMI between 18.5-29.9. Resident in Talesh. literate. Singleton birth with cephalic presentation Appropriate newborn weight( 2500 to 4000 gr) have a vaginal delivery with mediolateral episiotomy. No long-term rupture membrane more than 24 hours. lack medical disease history. Perineal swelling did not occur immediately after episiotomy. No addiction history No allergies to topical drugs. No manual removal of placenta 18 years 35 years Female Mother's reluctance to continue studying. Mother does not use silybum marianum ointment regularly and in accordance with the instructions. Mother should not wash episiotomy and in accordance with the order (less than twice a day). Mother has sex within 10 days of delivery. Perineal has been tampered with after any episiotomy repair. Excessive bleeding occurs in the first 24 hours of delivery. 090/1 Disruption of perineal obstetric wound Treatment - Drugs Placebo Intervention group: Silybum marianum ointment (produced in Shahid Beheshti pharmacy faculty) uses topically one finger amount (2cm) on episiotomy wounds twice for 10 days. Control group: ; placebo ointment (produced in Shahid Beheshti pharmacy faculty) uses topically one finger amount (2cm) on episiotomy wounds twice for 10 days. Intensity of episiotomy pain. Timepoint: before intervention, 12 hours, 5 and 10 days postpartum. Method of measurement: Visual Analogue Scale (VAS). Wound healing of episiotomy. Timepoint: before intervention, 12 hours, 5 and 10 days postpartum. Method of measurement: REEDA scale. Complete episiotomy repair. Timepoint: 10 day after delivery. Method of measurement: REEDA scale. vice chancellor for research of school of nursing and midwifery Shahid Beheshti university of medic Approved 2019-04-14 کمیته اخلاق دانشگاه علوم پزشکی و خدمات بهداشتی درمانی شهید بهشتی Tehran, Shahid Abbas poor Street Tehran Tehran Iran (Islamic Republic of)