Anastatica Hierochuntica Breathing Exercises Dysmenorrhea

NCT07481552 | Completed

• 1 other identifier: 2025-YÖNP-0104
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dysmenorrhea; Nonpharmalogical Pain Management

Keywords

pain; Breathing Exercises; Anastatica hierochuntica; dysmenorrhea

Outcome Measures

Primary Outcomes (1)

• Functional and Emotional Dysmenorrhea Impact (FEDI) Scale

  The Functional and Emotional Dysmenorrhea Impact (FEDI) scale is a multidimensional tool designed to assess the physical, functional, and emotional burden of menstrual pain. The scale consists of 14 items. Each item is scored on a 5-point Likert scale (ranging from 1 to 5). Total scores range from a minimum of 14 to a maximum of 70. A higher total score indicates a greater negative impact of dysmenorrhea on the individual's functional and emotional well-being, which represents a worse outcome.

  Measurements will be taken at enrollment (Day 0), on Day 1 of the second menstrual cycle (each cycle = 28 days), and on Day 1 of the third menstrual cycle following enrollment (each cycle = 28 days).

Secondary Outcomes (1)

• Visual Analog Scale (VAS) for Pain Intensity

  Measurements will be taken at enrollment (Day 0), on Day 1 of the second menstrual cycle (each cycle = 28 days), and on Day 1 of the third menstrual cycle following enrollment (each cycle = 28 days).

Study Arms (2)

Anastatica hierochuntica

EXPERIMENTAL

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: Anastatica hierochuntica

Breathing Exercises

ACTIVE COMPARATOR

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.

Other: Breathing Exercises

Interventions

Anastatica hierochuntica OTHER

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.

Anastatica hierochuntica

Breathing Exercises OTHER

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.

Breathing Exercises

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Women with dysmenorrhea
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women of reproductive age, between 18-35 years,
• Not using oral contraceptives,
• No history of gynecological surgery,
• Diagnosed gynecological conditions (endometriosis, PCOS, etc.),
• No chronic diseases,
• Regular menstrual cycles (bleeding for 3-8 days between 21-35 days of menstrual cycles),
• Reporting pain during the menstrual cycle,
• Pain level of 7 or higher on the VAS scale,
• Not having previously been pregnant and/or given birth were included in the study.

You may not qualify if:

• Individuals who have used hormonal medications, herbal products, or complementary/alternative therapies within the last 3 months,
• Individuals who regularly use analgesics or non-pharmacological methods (exercise, yoga, massage, etc.) for menstrual pain,
• Individuals with pelvic infection, active gynecological inflammation, or acute genital infection symptoms,
• Individuals with a history of significant stress, trauma, or psychiatric treatment within the last 6 months,
• Individuals with a history of neurological or psychiatric disorders that may affect pain perception,
• Individuals who suspected pregnancy during the intervention process or became pregnant at any stage of the study,
• Individuals with known allergies, intolerances, or intolerances to the intervention,
• Individuals who were considered unlikely to adhere to the study protocol (high risk of communication difficulties or loss of follow-up) were excluded.

Sponsors & Collaborators

• Çanakkale Onsekiz Mart University: lead

Study Sites (1)

Çanakkale Onsekiz Mart University

Çanakkale, Turkey (Türkiye)

Location

Related Publications (3)

• Gün, Ç. ve Demirci, N. (2014). Dismenore Etkilenmişlik Ölçeğinin Geliştirilmesi (Doctoral dissertation, Doktora Tezi, İstanbul).

  RESULT

• D.D. Price, P.A. McGrath, A. Rafii ve B. Buckingham, "The Validation of Visual Analogue Scales as Ratio Scale Measures for Chronic and Experimental Pain." Pain, cilt 17, sayı 1, ss. 45-56, 1983.

  RESULT

• Hopewell, S., Chan, A. W., Collins, G. S., Hróbjartsson, A., Moher, D., Schulz, K. F., ... & Boutron, I. (2025). CONSORT 2025 statement: updated guideline for reporting randomised trials. The Lancet, 405(10489), 1633-1640.

  RESULT

MeSH Terms

Conditions

Dysmenorrhea; Pain

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Fatma Şule Bilgiç, PhD

  Çanakkale Onsekiz Mart Unşversity

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Model Details: This study was designed as a randomized, parallel-group interventional trial. Eligible participants were randomly assigned in a 1:1 ratio to one of two intervention arms: the Anastatica hierochuntica application group or the breathing exercises group. Randomization was performed using computer-generated random numbers to ensure allocation concealment. Each participant received only the intervention assigned to their group, and no crossover between groups occurred during the study period. The interventions were administered over three consecutive menstrual cycles, and outcomes were assessed at baseline and after completion of the intervention period.

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: March 19, 2026
• Study Start: June 12, 2025
• Primary Completion: November 12, 2025
• Study Completion: December 28, 2025
• Last Updated: March 19, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)