The Effect of Malva sylvestris Cream on Episiotomy Pain and Healing: A Randomized Controlled Clinical Trial

Abstract

Background Episiotomy is one of the common procedures during childbirth in Iran, which causes pain, discomfort, and scar in the perineum. This study aimed to pursue the effect of Malva Sylvestris cream on episiotomy pain and healing. Methods This study was a double-blinded randomized-controlled clinical trial that was conducted from April to December 2021 at the Sina hospital in Ahvaz, Iran. Sixty women were selected and randomly assigned to control and intervention groups using block randomization. The main outcomes included pain assessment and episiotomy wound healing that are assessed by the Visual analog scale (VAS), and perineal healing scale included redness, edema, ecchymosis/bruising, discharge, approximation (REEDA). The cream was used twice a day for up to 14 days. The participants were followed on the first, seventh, and fourteenth days postpartum. Independent T-test, Mann-Whitney, and Chi-square, and Generalized Estimating Equations (GEE) model were used by SPSS software version 22 for data analysis. Statistically significant level was considered less than 0.05. Results There were no significant statistical differences between the two groups in demographic characteristics (P>0.05). No significant statistical differences were found in both groups in terms of perineal healing (B=-0.05; P=0.89) and pain scores (B=0.15; P=0.56). However, the chance of external dysuria in the intervention group decreased by 77% (P=0.01). Conclusion Despite showing the positive effect of Malva Sylvestris extract on wound healing in animal and in-vitro studies, this clinical study failed to show the positive effect of this extract on wound healing and pain relief of episiotomy. However, future clinical trials are needed to substantiate the above findings. Trial Registration Number: IRCT20190826044621N1.