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IRCT20190717044248N7 IRCT 2023-03-20 Rafsanjan University of Medical Sciences Evaluation the effect of Punica granatum var. pleniflora ( Persian Gulnar) ointment on pain severity and healing of episiotomy wound Evaluation the effect of Punica granatum var. pleniflora ( Persian Gulnar) ointment on pain severity and healing of episiotomy wound in primiparous women 2023-02-20 anticipated 90 Complete https://irct.ir/trial/61061 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individuals who will have the inclusion criteria will be selected with the Convenience Sampling method. The Permuted block randomization will be used to allocate people to two groups. In this study, nine blocks (every block has 10 paces) will be created, so that after determining Individuals who will have the inclusion criteria, the first 10 people who enter the study will be divided intotwo groups randomly (assigning 5 people to each group), then the next 10 people will be divided into two groups randomly in the same way, and this method will be continued until the last block. The output of the software will be English letters (A& B ) and each letter will be the representative of one of the intervention or control groups, Blinding description: At first, participants will be justified about the study, and will be informed consent will be taken. For blinding, the pharmacist will be asked to identify the medicine and placebo with the A_B group and the prescription in each package will be placed. So that the researcher would not know about the content of packages (medicine or placebo). The medicine is also will be given to participants as A or B , and participants will not be informed of the content of packages (medicine or placebo). This blinding will also be available for the analyzer, and after finishing the statistical analysis the content of packages (medicine or placebo) will be asked from pharmacists. 3 Episiotomy. Intervention 1: Intervention group apply as much as a fingertip 5% of Persian Gulnar ointment made by SHahid Beheshti School of Pharmacy in Tehran 2 hours after delivery on the episiotomy site. Intervention 2: Control group apply as much as a fingertip of userin ointment made by SHahid Beheshti School of Pharmacy in Tehran 2 hours after delivery on the episiotomy site. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of information
public Maryam Azarian far
NO.1, Keshavarz 2 Alley, Sharaf Abad Ave
Yasuj Iran (Islamic Republic of) 7591637816 +98 74 3344 4656 azarian.maryam.98@gmail.com Rafsanjan University of Medical Sciences scientific Zahra Saghafi
nursing and midwifery scool, sahely Blvd, Motahary street
Rafsanjan Iran (Islamic Republic of) 7718145056 +98 34 2834 7100 z.saghafi@yahoo.com Rafsanjan University of Medical Sciences Iran (Islamic Republic of) Inform consent for participant in the study Willingness to normal vaginal delivery Selection of Niknafs Maternity Center of Rafsanjan as the place of delivery Mother age between 18-35 years Pregnancy age: 38 weeks based on reliable first-trimester ultrasound or last menstrual period Single-fetal with a cephalic presentation based on the latest ultrasound results primiparous women Iranian nationality vaginal delivery with median or medio laterl incision BMI 18/5-30 18 years 35 years Female Sensitivity to Punica granatum var. pleniflora known history of psychological illness History of psychological problems during 6 month ago Consumption of Antidepressant medication Drug consumption Treatment - Drugs Placebo Intervention group apply as much as a fingertip 5% of Persian Gulnar ointment made by SHahid Beheshti School of Pharmacy in Tehran 2 hours after delivery on the episiotomy site Control group apply as much as a fingertip of userin ointment made by SHahid Beheshti School of Pharmacy in Tehran 2 hours after delivery on the episiotomy site Intensity of pain. Timepoint: Determination of intensity of pain score before applying the ointment, fifth and tenth after delivery. Method of measurement: Visual Analogue Scales of intensity pain. Healing of episiotomy. Timepoint: Determination of healing of episiotomy before applying the ointment, fifth and tenth after delivery. Method of measurement: REEDA. Rafsanjan University of Medical Sciences Approved 2022-01-10 Ethics committee of Rafsanjan University of Medical Sciences Emam Ali Blvd, Rafsanjan Rafsanjan Kerman Iran (Islamic Republic of)