Trial reportPloS one2024
The effect of Camellia sinensis ointment on perineal pain and episiotomy wound healing in primiparous women: A triple-blind randomized clinical trial.
Trial report in PloS one, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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5 authors.
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Abstract
BACKGROUND AND
objectiveEpisiotomy is one of the most commonly performed procedures in obstetrics. complications of episiotomy are pain, bleeding, infection, pain in the sitting position, and difficulty in taking care of the baby. This study aimed to investigate the effect of Camellia sinensis ointment on perineal pain and episiotomy wound healing in primiparous women.
methodsThis triple-blinded randomized clinical trial was conducted on 60 primiparous women who were referred to the maternity ward of Al-Hadi hospital in Shoushtar and Ganjovian hospital in Dezful, Iran, from 2020 to 2021. Participants were randomly assigned into two groups of intervention (Camellia sinensis extract ointment) and control (placebo) with a follow-up of 14 days. REEDA scale (redness, edema, ecchymosis, discharge, and approximation) was used to measure wound healing and the Visual Analog Scale (VAS) was used to measure the pain intensity.
resultsThere was no significant difference between two groups before intervention in terms of sociodemographic characteristics, pain intensity, and episiotomy wound status. Scores of pain intensity and wound healing reduced on days 7, 10, and 14 post-intervention in the intervention group compared to placebo. There was a significant decrease between the groups of intervention and control in terms of the mean score of pain intensity (VAS scale) on day 10 (1.33 ± 0.71, 1.77 ± 0.93) and day 14 (0.73 ± 0.74, 1.13 ± 0.81) post-intervention (P < 0.05). Also, on day 14 post-intervention, there was a significant decrease between the groups of intervention and control in terms of the mean score of episiotomy wound healing (REEDA index) (0.53 ± 0.77, 1.77 ± 1.46) (P < 0.05). The GLM test was applied for repeated measures. REEDA index and VAS scale changed during different times (time-variable) (p < .001). But, the studied groups (group variable) and the studied groups (interaction effect of group * time) did not affect the changes in the REEDA index (p = .292, p = .306) and VAS scale (p = .47) during different times.
conclusionOur study showed that Camellia sinensis extract ointment has a small effect on the healing process and pain reduction of episiotomy wounds. to confirm its effect, a study with a larger sample size should be conducted.
trial registrationThis trial was registered in the Iranian Registry of Clinical Trials on 04/10/2019 with the IRCT ID: IRCT20190804044428N1. Participants were enrolled between 11 April 2020 and 20 January 2021. URL of registry: https://en.irct.ir/trial/41326.
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