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. 2022 Aug 9;23(1):637.
doi: 10.1186/s13063-022-06583-4.

The effects of Rosa foetida extract along with self-care education on primary dysmenorrhea: study protocol for a randomized clinical trial

Fatemeh Shabani  1 , Shabnam Omidvar  2 , Parvin Sajadi Kaboudi  3 , Hajar Pasha  4 , Soraya Khafri  5 , Hossein Najafzadehvarzi  6 , Fatemeh Nasiri Amiri  4 , Mahbobeh Faramarzi  4 , Zinatossadat Bouzari  4
Affiliations

The effects of Rosa foetida extract along with self-care education on primary dysmenorrhea: study protocol for a randomized clinical trial

Fatemeh Shabani et al. Trials. .

Abstract

Background: Dysmenorrhea is one of the most common disorders among young women. Medicinal herbs are one of the alternative methods for the treatment of dysmenorrhea. This study will investigate the effect of Rosa foetida extract, along with self-care behavior education on primary dysmenorrhea among female students of Babol University of medical sciences.

Methods/design: A randomized clinical trial will be performed on single students, aged 18 to 24 years. The research samples will be divided into three groups. The students will receive self-care behavior education on dysmenorrhea. Following the education, two of the groups will receive Rosa foetida extract capsules and placebo capsules in two consecutive cycles every 8 h for two successive days, respectively. The capsules will have similar physical appearance. The third group will not receive any medication. Data will be collected through demographic characteristic questionnaire, visual analog scale, dysmenorrhea self-care behaviors scale questionnaire, pictorial chart, and menstrual distress scale questionnaire. In order to determine and compare the effect of pharmacological and educational interventions on the severity of dysmenorrhea in groups, an ANOVA analysis of variance test with repeated measures will be used by SPSS software version 22.

Discussion: The results will show the effects of Rosa foetida extract along with self-care behavior education on primary dysmenorrhea, and beneficial effects that may be found in the trial of this plant may be of use for women with the same problem.

Ethics and dissemination: The study is approved by the Ethics Committee of Babol University of Medical Sciences (IR.MUBABOL.REC.1397.059).

Trial registration: IRCT 20190318043086N1. Registered on 14 June 2019.

Keywords: Clinical protocol; Dysmenorrhea; Medicinal plants; Self-caring.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

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Fig. 1
Consolidated Standards of Reporting Trials (CONSORT) flow diagram
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