Abstract
BackgroundEpisiotomy is the most commonn surgical procedure in midwifery which as any other wounds can cause infection or delay in healing.The current study aimed to determine effect of Silybum marianum ointment on pain severity and healing of episiotomy wound in primiparous women referring to Shahid Nourani Hospital at 2019.MethodsThis research was done as a randomized, triple-blind clinical trial on 87 priiparous women (44 indivdiuals in Silybum marianum ointment group and 43 indivdiuals in placebo group) referred to Shahid Nourani Hospital in Talesh (Guilan Province), Iran at September 2019.After labor and performing episiotomy, twice a day for 10 days as a fingertip size of the ointment was prescribed to be topically used on the episiotomy incision for both groups (Silybum marianum ointment or placebo ointment).Data gathering was done using demographic and midwifery information questionnaire, Episiotomy healing assessment: Redness, Edema, Ecchymosis, Discharge, Approximation)REEDA Scale (REEDA Scale: Redness(R); Edema (E), Ecchymosis(E), Discharge from the wound(D); Approximation of the perineal tissues(A))(scale, and visual analogue scale of pain. Examination of healing status of the perinea incision was performed during first 12 h, fifth day and tenth day after labor.Kolmogrov-Smirnov test was used in order to investiagte nomrality of data distribution of quantitative data, and two- independent samples t test, Chi square, repeated measures two factorial analysis of variance and Fischer’s exact test were used. SPSS software version 23 was used to analyze data and 0.05 was considered as signifcance level.ResultsBoth groups of Silybum marianum and placebo groups did not differ regarding demographic and midwifery characteristics, hygiene status prior to intervention (P > 0.05).Mean difference of pain severity and REEDA scale in Silybum marianum ointment group in 12 h after labor, at fifth day and tenth day after labor was significant comparing to control group which indicates decline in episiotomy pain severity and faster wound healing (P < 0.001).ConclusionsSilybum marianum ointment ointment accelerates episiotomy wound healing rate due to its healing properties and decreases pain severity.Trial registrationThis study was registered in Iranian Registry of Clinical Trials in 10/08/2019 with the IRCT ID: IRCT201811100411603N1.
Highlights
Episiotomy is the most commonn surgical procedure in midwifery which as any other wounds can cause infection or delay in healing.The current study aimed to determine effect of Silybum marianum ointment on pain severity and healing of episiotomy wound in primiparous women referring to Shahid Nourani Hospital at 2019
Antimicrobial, antifungal, anti-inflammatory, and analgesic properties of S. marianum in a few studies [8, 43, 44], and due to that there is no research to date through randomized controlled design in order to assess the topical Silybum marianum seed ethanol extract on wound healing in human, and since there is a need to use of effective, low risk, accessible and low-cost methods for postpartum women, the current study aimed to determine effect of Silybum marianum ointment on wound healing and pain severity of episiotomy in primiparous women
Out of the 90 participants at the beginning of the study, individuals were in the placebo group and one in the S. marianum group
Summary
Study design and participants This is a randomized, triple-blind clinical trial performed to assess effect of Silybum marianum ointment on wound healing and pain severity of episiotomy in primiparous women in 2019. This trial adhered to CONSORT guidelines and included CONSORT checklist as a supplementary file 1. Side effects of the medication include allergy, infection, itching, burning, stinging, dryness in the region of wound, fever and ague and health status sheet including six questions on health issues to assess adherence to perinea health by each participant which was used in two studies previously [27, 46] and was made by the researcher. Women eligible to participate in the study were enrolled voluntarily and with written consent at the beginning of the study and with a commitment not to impose costs on participants, having the right to dispense as well as confidentiality of information
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