The effect of Nigella sativa cream on pain and wound healing of episiotomy in Primiparous women

This study investigated the effects of nigella sativa cream on pain and wound healing episiotomy was performed.

This study was triple blind clinical trial on 124 women referring to hospital Vali Asr birjand, Iran were chosen purposefully. were selected easy method and then using a randomized block design with Three intervention groups (nigella sativa cream)placebo and control groups.

124 primiparous women referring to Valiaser Hospital for normal delivery are selected as samples after gaining the consent of the patients and controlling the inclusion and exclusion criteria. For the first time, Four hours after the completion of episiotomy recovery, and later washing the perineal with saline serum and drying, amount of a knuckle of medication or placebo is used with latex gloves on the wound, in a way that it covers the whole surface. Before intervention and giving tranquilizer,12 hours after intervention and days the first, seventh and tenth after delivery, the patient's perineal pain is measured through McGill’s shortened questionnaire.The time cream usage in both groups is two times a day, which continues for ten days. In control group, individuals will receive usual health recommendations according to the country’s protocol. On the first, Seventh, and tenth day, wound appearance is checked via the REEDA tool. 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.

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 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; curettage procedure the first 24 hours after birth; the third stage of labor longer than 30 minutes; no need for episiotomy ,not use the cream on a regular; puerperal fever; complications resulting from the use of Nigella sativa cream؛ having intercourse to the end of the study (10 days postpartum).

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. In the group placebo, placebo cream containing simple base cream (Cold Cream) are used. Units of study placebo 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. In control group, individuals will receive usual health recommendations according to the country’s protocol.

Pain of episiotomy, Wound healing of episiotomy

Mashhad University Of Medical Sciences

For randomly balanced block assignment which is 3 blocks (student, Doctor, midwife) the research units was placed in 3 groups (medicine, placebo , control).

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.