The effect of Camellia sinensis ointment on perineal pain and episiotomy wound healing in primiparous women: A triple-blind randomized clinical trial.


Journal

PloS one
ISSN: 1932-6203
Titre abrégé: PLoS One
Pays: United States
ID NLM: 101285081

Informations de publication

Date de publication:
2024
Historique:
received: 24 10 2023
accepted: 21 05 2024
medline: 1 8 2024
pubmed: 1 8 2024
entrez: 1 8 2024
Statut: epublish

Résumé

Episiotomy 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. This 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. There 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. Our 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. This 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.

Sections du résumé

BACKGROUND AND OBJECTIVE OBJECTIVE
Episiotomy 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.
METHODS METHODS
This 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.
RESULTS RESULTS
There 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.
CONCLUSION CONCLUSIONS
Our 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 REGISTRATION BACKGROUND
This 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.

Identifiants

pubmed: 39088486
doi: 10.1371/journal.pone.0305048
pii: PONE-D-23-34058
doi:

Substances chimiques

Ointments 0
Plant Extracts 0

Types de publication

Journal Article Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

e0305048

Informations de copyright

Copyright: © 2024 Sayahi et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Déclaration de conflit d'intérêts

The authors have declared that no competing interests exist.

Auteurs

Masoumeh Sayahi (M)

Department of Midwifery, Shoushtar Faculty of Medical Sciences, Shoushtar, Iran.

Azam Jahangirimehr (A)

Department of Public Health, Shoushtar Faculty of Medical Sciences, Shoushtar, Iran.

Zahra Hatami Manesh (Z)

School of Nursing and Midwifery, Dezful University of Medical Sciences, Dezful, Iran.

Faraz Mojab (F)

Department of Pharmacognosy, School of Pharmacy, Pharmaceutical Sciences Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Maryam Nikbina (M)

Department of Midwifery, Shoushtar Faculty of Medical Sciences, Shoushtar, Iran.

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Classifications MeSH