NCT07481552

Anastatica Hierochuntica Breathing Exercises Dysmenorrhea

The Effect of Anastatica Hierochuntica and Breathing Exercises on Dysmenorrhea: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Çanakkale Onsekiz Mart University · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

This randomized controlled trial was conducted between June 12 and December 29, 2025, among female university students to evaluate the effects of Anastatica hierochuntica application and breathing exercises on functional and emotional dysmenorrhea. The study was designed and reported in accordance with the CONSORT 2025 guidelines. The sample size was calculated based on previous research examining the effects of telerehabilitation on dysmenorrhea, with a power of 80% and a margin of error of 0.05. Although the minimum required sample size was determined as 54 participants, a total of 100 women with dysmenorrhea were included to account for potential attrition. No participants were lost during the study, and the trial was completed with 100 women, with 50 participants allocated to each group. Participants were recruited through announcements disseminated via official university social media accounts and student information platforms. Women aged 18-35 years who reported regular menstrual cycles and severe menstrual pain (Visual Analog Scale \[VAS\] score ≥7) were screened for eligibility. Eligible participants were randomly assigned in a 1:1 ratio to either the Anastatica hierochuntica group or the breathing exercises group using computer-generated randomization. Allocation concealment was ensured using sequentially numbered, opaque, sealed envelopes prepared by an independent researcher. In the Anastatica hierochuntica group, participants received the intervention on the first day of menstruation once per cycle for three consecutive menstrual cycles. The application was performed in a quiet and dimly lit obstetrics laboratory setting without any physical contact. The plant was placed in water until fully opened, after which it was removed and the water discarded. In the breathing exercises group, participants were instructed in the 4-7-8 breathing technique on the first day of menstruation. The initial session was conducted under researcher supervision, and participants were advised to perform the exercise during periods of peak pain intensity on the first day of menstruation. This intervention was also continued for three consecutive menstrual cycles. Data were collected at baseline and at the end of the third menstrual cycle using a structured Data Collection Form, the Visual Analog Scale, and the Functional and Emotional Dysmenorrhea Scale (FEDS). The primary outcome was the change in functional and emotional dysmenorrhea levels following the interventions. Ethical approval was obtained prior to data collection, and written informed consent was secured from all participants. The study was conducted in accordance with the principles of the Declaration of Helsinki.

Detailed description

This randomized controlled trial was conducted between June 12 and December 29, 2025, among female university students. The study was designed and reported in accordance with the CONSORT 2025 guidelines (Hopewell et al., 2025). Population and Sample Size The sample size was calculated based on previous studies examining the effects of telerehabilitation on dysmenorrhea (Baltaş et al., 2023). Based on the reported effect sizes, a power analysis was conducted with an 80% power and a 0.05 margin of error, resulting in a minimum required sample size of 54 participants (27 per group). Considering potential attrition, 100 women with dysmenorrhea were planned to be included, with 50 participants allocated to each group. No losses occurred during the study, and the trial was completed with a total of 100 women (50 per group). Inclusion Criteria Participants were included if they: Were of reproductive age (18-35 years), Did not use oral contraceptives, Had no history of gynecological surgery, Had no diagnosed gynecological conditions (e.g., endometriosis, polycystic ovary syndrome), Had no chronic diseases, Reported regular menstrual cycles (21-35-day cycle length with bleeding lasting 3-8 days), Reported experiencing menstrual pain, Had a Visual Analog Scale (VAS) score of 7 or higher, Had no history of pregnancy and/or childbirth. Exclusion Criteria Participants were excluded if they: Had used hormonal medications, herbal products, or complementary/alternative therapies within the last three months, Regularly used analgesics or non-pharmacological pain management methods (e.g., exercise, yoga, massage) for menstrual pain, Had pelvic infection, active gynecological inflammation, or acute genital infection, Had experienced severe stress, trauma, or psychiatric treatment within the last six months, Had neurological or psychiatric conditions that could affect pain perception, Became pregnant or had suspected pregnancy during any stage of the study, Had known allergies, intolerance, or inability to tolerate the interventions, Were considered unlikely to comply with the study protocol due to communication difficulties or high risk of follow-up loss. Randomization During the study, 320 women were assessed for eligibility, and 14 declined to participate. The remaining 306 women underwent VAS assessment, and eligibility was further evaluated based on additional inclusion criteria. A total of 216 women who did not meet the inclusion criteria were excluded. One hundred women who met the eligibility criteria and provided written informed consent were enrolled and randomly assigned to the intervention groups. Randomization was performed using Random Allocation Software (version 1.0) with a 1:1 allocation ratio. To ensure allocation concealment and minimize selection bias, the randomization sequence was generated by an independent researcher not involved in participant recruitment or data collection. Group assignments were placed in sequentially numbered, opaque, sealed envelopes and were opened only after participant enrollment. Participants were randomly allocated into two parallel groups: the Anastatica hierochuntica Group and the Breathing Exercises Group. No participants were lost to follow-up, and the study was completed with a total of 100 women. The enrollment, allocation, follow-up, and analysis processes are presented using the CONSORT 2025 flow diagram (Figure 1). Data Collection Instruments Data Collection Form: A structured data collection form was developed based on the literature (Baltaş et al., 2023; Ucak, 2020; Erenoğlu et al., 2017; Potur \& Kömürcü, 2013). The form consisted of 35 questions addressing sociodemographic characteristics, obstetric history, and menstrual cycle characteristics. Additionally, a 10-item section was included to assess the impact of dysmenorrhea on physical, psychological, social, and daily life domains. Visual Analog Scale (VAS): Pain intensity was assessed using the Visual Analog Scale developed by Price et al. (1983). The scale consists of a 10-cm horizontal line ranging from 0 (no pain) to 10 (worst imaginable pain). Scores below 3.4 indicate mild pain, scores between 3.5 and 6.4 indicate moderate pain, and scores of 6.5 or higher indicate severe pain. The Turkish validity and reliability study was conducted by Aslan (2004), reporting a validity coefficient of 0.48 and a reliability coefficient of 0.90. Functional and Emotional Dysmenorrhea Scale (FEDS): The Functional and Emotional Dysmenorrhea Scale consists of 14 items and two subscales assessing functional and emotional aspects of dysmenorrhea. The scale was developed by Li et al. (2012), and its Turkish validity and reliability were established by Gün and Demirci (2014). Items are scored on a 5-point Likert scale, with higher scores indicating greater functional and emotional impairment due to dysmenorrhea. The Cronbach's alpha coefficient of the scale is 0.91. Intervention Study announcements were disseminated through the official social media accounts and student information platforms of the university. Applicants were contacted online for preliminary screening. Eligible participants attended face-to-face assessments, during which pain intensity was measured using the VAS on the first day of menstruation. Only women with a VAS score of 7 or higher and who met all inclusion criteria were enrolled. Participants were randomized into two groups, and baseline assessments were conducted using the Data Collection Form and the Functional and Emotional Dysmenorrhea Scale. Anastatica hierochuntica Group: Participants in this group received the Anastatica hierochuntica (Mary's Hand Herb) intervention on the first day of menstruation. The intervention was administered once per menstrual cycle for three consecutive cycles. Participants were invited to the obstetrics laboratory of the midwifery department, where a quiet and dimly lit environment with mats and examination couches was provided. Participants were asked to lie in a comfortable position. The plant was placed in water until it fully opened, after which it was removed and the water was discarded. No physical contact with the participant's body occurred during the procedure. The plant was odorless, and the intervention was completed after removal of the opened plant from the environment. Breathing Exercises Group: Participants in this group received instruction on the 4-7-8 breathing technique on the first day of menstruation. Participants were seated upright and instructed to inhale through the nose for 4 seconds, hold the breath for 7 seconds, and exhale through the mouth for 8 seconds. The exercise was performed in four sets, with a total duration of approximately 2 minutes (Önder, 2019). The first session was conducted under researcher supervision in the obstetrics laboratory. Participants were then advised to perform the breathing exercises during periods of peak pain intensity on the first day of menstruation. This intervention was continued for three consecutive menstrual cycles. The Functional and Emotional Dysmenorrhea Scale was administered to participants in both groups at baseline and again at the end of the third menstrual cycle, on the day menstruation ended. Ethical Considerations Ethical approval was obtained prior to data collection (11.06.2025; No: 2025-YÖNP-0104). Institutional permission was secured from the university where the study was conducted. Permission to use the measurement scales was obtained from the respective authors. Verbal and written informed consent was obtained from all participants. The study was conducted in accordance with the principles of the Declaration of Helsinki.

Conditions

• Dysmenorrhea
• Nonpharmalogical Pain Management

Interventions

Type	Name	Description
OTHER	Anastatica hierochuntica	participants allocated to this arm received an Anastatica hierochuntica (Rose of Jericho) application during menstruation. The intervention was administered on the first day of each menstrual cycle, once per cycle, over three consecutive cycles. The dried plant was placed in water and allowed to fully open naturally in a quiet and dimly lit laboratory environment. Participants rested in a comfortable position during the application. No physical contact or additional therapeutic procedures were applied. After the completion of the session, the plant was removed and the water was discarded. The intervention was conducted under standardized conditions and supervised by the researchers.
OTHER	Breathing Exercises	Participants assigned to this arm received a structured breathing exercise intervention based on the 4-7-8 breathing technique. The exercise was introduced on the first day of the menstrual cycle. Participants were instructed to inhale through the nose for 4 seconds, hold the breath for 7 seconds, and exhale slowly through the mouth for 8 seconds. Each session consisted of four consecutive sets and lasted approximately 2 minutes. The initial session was conducted under researcher supervision in a laboratory setting. Participants were subsequently advised to perform the breathing exercise on the first day of menstruation at the time when menstrual pain was perceived as most intense. The intervention was repeated across three consecutive menstrual cycles.

Timeline

• Start date: 2025-06-12
• Primary completion: 2025-11-12
• Completion: 2025-12-28
• First posted: 2026-03-19
• Last updated: 2026-03-19

Locations

1 site across 1 country: Turkey (Türkiye)