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IRCT20170425033642N1 IRCT 2018-01-07 Mashhad University of Medical Sciences The effect of Nigella sativa cream on pain and wound healing of episiotomy in Primiparous women The effect of Nigella sativa cream on pain and wound healing of episiotomy in Primiparous women 2017-04-17 anticipated 135 Complete https://irct.ir/trial/25898 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomly balanced block assignment which is 3 blocks (student, Doctor, midwife) the research units was placed in 3 groups (medicine, placebo , control), Blinding description: The researcher and research units were not aware of cream type (medicine, placebo) and the statistical analyzer was not also aware of randomly assignment of research units. N/A Wound healing of episiotomy , pain of episiotomy. Intervention 1: In the intervention group, nigella sativa cream (0.5 %) percent of the combined value is Cold Cream with nigella sativa has been used. Units of study nigella sativa cream the size of a finger is placed on the sutures so that the wound is completely covered and do the daily double (each 12h) up ten days. Intervention 2: Intervention group: Units of study placebo cream the size of a finger is placed(containing simple base cream) on the sutures so that the wound is completely covered and do the daily double (each 12h) up ten days. Intervention 3: The control group will be cured at the hospital during the 10 days. Undecided - It is not yet known if there will be a plan to make this available
public Nahid Barati
School of Nursing and Midwifery, Doktora Intersection
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 4423 3808 baratin931@mums.ac.ir Mashhad University of Medical Sciences scientific Massoumeh kordi
School of Nursing and Midwifery, Doktora Intersection
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 kordim@mums.ac.ir School of Nursing and Midwifery , Mashhad Iran (Islamic Republic of) Inclusion criteria: nulliparous women aged 18-35 years old; living in the city of Birjand, Iran; at least having the ability to read and write; living with his wife's; body mass index ranging from 19/8-30; non-smoking and no drug dependence; no history of disease impaired wound healing; not using drugs effecting on wound healing; single fetal cephalic; lack of symptomatic infections of the vagina and vulva (the infectious discharge, itching, burning); low blood, anal lesions; vulva and perineum on admission; and rupture of the fetal sac up to 12 hours before the start of pains; lack of stricture restriction pelvic; embryos is vital; the lack of apparent anomalies in the newborn. No rectocel, cystocele severe (grade 2 or higher), wall or mass in the vaginal; no history of obstetric complications; no history of vaginal reconstructive surgery on the Vagina and urethra. 18 years 35 years Female Exclusion criteria: there interfere with the progress of labor; prolonged second stage of labor longer than 2 hours; delivery devices (vacuum, forceps); delivered via cesarean section; extend the length of the incision or there tear except episiotomy tear; infant hospitalization in the NICU; abnormal vaginal bleeding; shoulder dystocia (leading to the maneuvers other than Robert Mack); manual removal of placenta; hematoma; having intercourse to the end of the study (10days postpartum); curettage procedure the first 24 hours after birth; the third stage of labor longer than 30 minutes; the occurrence of an adverse event at 10 days postpartum; no need for episiotomy; not use the cream on a regular; puerperal fever; complications resulting from the use of nigella sativa cream. O90.1 Disruption of perineal obstetric wound Treatment - Drugs Placebo N/A In the intervention group, nigella sativa cream (0.5 %) percent of the combined value is Cold Cream with nigella sativa has been used. Units of study nigella sativa cream the size of a finger is placed on the sutures so that the wound is completely covered and do the daily double (each 12h) up ten days. Intervention group: Units of study placebo cream the size of a finger is placed(containing simple base cream) on the sutures so that the wound is completely covered and do the daily double (each 12h) up ten days. The control group will be cured at the hospital during the 10 days. Pain of episiotomy. Timepoint: Immediately before the intervention,12 hours after intervention and days the first, seventh and tenth after delivery. Method of measurement: McGill Pain Questionnaire short. Wound healing of episiotomy. Timepoint: Days the first, ُseventh and tenth after delivery. Method of measurement: Reeda scale. Mashhad University of Medical Sciences Approved 2017-01-07 Ethics committee of Mashhad University Of Medical Sciences School of Nursing and Midwifery, Doktora Intersection , Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)