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IRCT201511123860N15 IRCT 2015-12-02 vice chancellor for research of School of Nursing and Midwifery of Shahid Beheshti University of Med Effect of Verbascum cream on perineal pain intensity and episiotomy healing Evaluating the effect of Verbascum Thapsus cream on perineal pain intesity and episiotomy healing in primiparous women 2015-11-22 anticipated 100 Complete https://irct.ir/trial/3984 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive. N/A Episiotomy. Intervention 1: Intervention group: Verbascum cream (produced in Shahid Beheshti pharmacy faculty) is used as much as one finger amount (2cm) on episiotomy wounds twice per day for 10 days. Intervention 2: In control group; placebo cream (produced in Shahid Beheshti pharmacy faculty) uses topically one finger amount (2cm) on episiotomy wounds twice for 10 days.
public Gity Ozgoli
School of Nursing and Midwifery, Niayesh Highway, Valiasr St, Tehran, Iran
Tehran Iran (Islamic Republic of) +98 21 8820 2512 g.ozgoli@gmail.com School of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences scientific Gity Ozgoli
School of Nursing and Midwifery, Niayesh Highway, Valiasr St, Tehran, Iran
Tehran Iran (Islamic Republic of) +98 21 8820 2512 g.ozgoli@gmail.com School of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria:primiparous woman; Age between 18 to 35 years; living in the city of Saveh, Iran; At least having the ability to read and write; Non-smoking and drug abuse; Body mass index ranging from 18/5-30; Gestational age between 37 to 42 weeks; Single pregnancy with cephalic presentation; Newborn weight between 2500 to 4000 grams; Normal vaginal delivery without devices; Medio-lateral episiotomy with 4-3 cm length; Non infant hospitalization in the NICU; No have history of obstetric complications such as (preeclampsia and eclampsia, Gestational diabetes, Placental abruption, chorioamnionitis, premature rupture of memberanous more than 24 hours); No have severe anemia; Disorder of progression in time for the second stage of labor more than 14 hours more than 2 hours for the third stage more than half an hour; Non Diseases affecting wound healing (Chronic systemic disease, pulmonary disease, coagulation disorders, connective tissue, diabetes, anemia, immunodeficiency, hemophilia, malnutrition, mental disorders, renal failure); Consumption of drugs affecting wound healing (glucocorticoids, anti- coagulatives, anti- epileptic, immune system suppressants, antibiotics or chemotherapy agents); No have allergy to herbal drug; Lack of conflict between the family and the severe financial difficulties in recent months. Exclusion criteria: Unwillingness to continue participating in the study; Lack of care for designated days; Do not use ointments regularly and as directed; Allergy to verbascum cream; Hematoma in the episiotomy after delivery; The need for perineal reconstruction after episiotomy; Fever and postpartum infection; Severe constipation after childbirth during the study; Hemorrhoids or anal fissure after delivery; Use betadine or sitzbath during the study; Having sex in the first 10 days after episiotomy l 17 years 35 years Female O90.1 Disruption of perineal obstetric wound Treatment - Drugs Placebo Intervention group: Verbascum cream (produced in Shahid Beheshti pharmacy faculty) is used as much as one finger amount (2cm) on episiotomy wounds twice per day for 10 days. In control group; placebo cream (produced in Shahid Beheshti pharmacy faculty) uses topically one finger amount (2cm) on episiotomy wounds twice for 10 days Wound healing of episiotomy. Timepoint: Before intervention,24 hours after delivery, 3 and 10 days after delivery. Method of measurement: REEDA scale. Pain intensity. Timepoint: Before intervention,24 hours after delivery, 3 and 10 days after delivery. Method of measurement: Numerical Analouge Scale. Sedative tablets counting. Timepoint: 10 day after delivery. Method of measurement: questionnaire. Common discontent after childbirth. Timepoint: 10 day after delivery. Method of measurement: questionnaire. vice chancellor for research of School of Nursing and Midwifery of Shahid Beheshti University of Med Approved 2015-08-08 Ethics committee of School of Pharmacy and Nursing and Midwifery of Shahid Beheshti University of M School of Nursing and Midwifery, Niayesh Highway, Valiasr St, Tehran, Iran Tehran Iran (Islamic Republic of)