Clinical trial NCT07020338: Yoga Effects in Primary Dysmenorrhea
Official title: Effects of Yoga on Menstrual Symptoms, Pain, Sleep Quality, and Aerobic Endurance in Young Women With Primary Dysmenorrhea: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dysmenorrhea
Keywords: Primary dysmenorrhea
Yoga
Menstrual symptoms
Sleep quality
aerobic endurance
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study used a parallel-group randomized controlled trial design. Participants were randomly assigned to either a yoga intervention group or a control group in a 1:1 ratio. Each participant remained in their assigned group for the entire study duration, and there was no crossover between groups. The outcome assessor was blinded to group allocation (single-blind design).
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial was to assess whether a yoga-based exercise program could improve aerobic endurance, sleep quality, and reduce menstrual symptoms and pain in young women aged 18-25 with primary dysmenorrhea.

The main questions it aimed to answer were:

Did yoga reduce menstrual pain and symptom severity?

Did yoga improve sleep quality and aerobic endurance?

Researchers compared a yoga intervention group to a control group to determine whether the yoga program led to improvements in these outcomes.

Participants:

Were randomly assigned to either a yoga group or a control group

Completed assessments of menstrual pain (VAS), menstrual symptoms (Menstrual Symptom Scale), sleep quality (Sleep Diary), and aerobic endurance (Incremental Shuttle Walk Test and Endurance Shuttle Walk Test)

In the intervention group, attended 50-minute yoga sessions twice a week for three menstrual cycles

Participants in the control group were offered the same yoga program after the study period.

Detailed description: Primary dysmenorrhea, defined as painful menstruation without an identifiable pelvic pathology, is one of the most prevalent gynecological conditions among young women, affecting up to 90% of this population. It is typically characterized by cramping lower abdominal pain, often accompanied by back or thigh discomfort, and may be associated with systemic symptoms such as nausea, fatigue, and gastrointestinal disturbances. These symptoms can impair daily functioning, reduce sleep quality, and limit physical activity and endurance. While pharmacologic treatments remain first-line therapy, non-pharmacologic, low-risk, and accessible interventions such as yoga have gained attention for their potential holistic benefits.

This randomized controlled trial was designed to evaluate the effects of an 8-week structured yoga program on aerobic endurance, sleep quality, menstrual pain, and menstrual symptom severity in young women with primary dysmenorrhea.

A total of 32 female participants, aged 18-25 years, who had reported primary dysmenorrhea with menstrual pain intensity greater than 40 mm on the Visual Analog Scale (VAS) for at least the past 6 months, were recruited and randomly assigned to either a yoga intervention group (n = 16) or a control group (n = 16). Participants were recruited through convenience and snowball sampling methods via social media and community announcements. Exclusion criteria included regular physical exercise, irregular menstrual cycles, pregnancy, prior childbirth, pelvic surgery, or use of hormonal or psychiatric medications.

The yoga program was delivered twice weekly in 50-minute sessions for 8 weeks (across three menstrual cycles). It included:

Asanas (postures) targeting flexibility and pelvic mobility

Pranayama (breathing exercises) aimed at autonomic regulation

Relaxation and mindfulness components to reduce stress and improve sleep

All participants underwent assessments at three timepoints (baseline, after menstrual cycle 1, and after menstrual cycle 3), specifically during the first 3 days of their menstruation.

Outcome Measures:

Pain intensity: assessed via Visual Analog Scale (VAS)

Menstrual symptoms: evaluated using the Menstrual Symptom Questionnaire (MSQ)

Attitudes toward menstruation: measured through the Menstrual Attitude Questionnaire (MAQ)

Sleep quality: assessed with a Sleep Diary, capturing both quantitative sleep parameters and subjective quality

Aerobic endurance: measured using two field tests:

Incremental Shuttle Walk Test (ISWT) - to evaluate maximum aerobic capacity

Endurance Shuttle Walk Test (ESWT) - to assess submaximal endurance at 70-85% VO₂peak

Each test included pre- and post-assessment of vital signs (heart rate, oxygen saturation, blood pressure) and perceived exertion (Modified Borg Scale). Testing was stopped according to safety thresholds (e.g., failure to match the pace, HR \>85% max, or participant-reported symptoms).

The primary hypothesis was that the yoga group would show statistically significant improvements in sleep quality and aerobic endurance, and reductions in menstrual pain and symptom severity, compared to the control group.

This study aimed to contribute to the growing body of evidence supporting yoga as a safe, accessible, and non-invasive strategy to manage primary dysmenorrhea and its associated physical and psychological burdens in young women. The findings may have implications for broader implementation in university and workplace settings to support menstrual and general well-being.

Eligibility criteria: Inclusion Criteria:

* participants aged 18 to 25 years
* Regular menstrual cycles (28 ± 7 days)
* History of primary dysmenorrhea for at least the past 6 months
* Menstrual pain intensity ≥40 mm on the Visual Analog Scale (VAS) during menstruation
* No history of childbirth
* Voluntarily agreed to participate and provided informed consent

Exclusion Criteria:

* History of pelvic surgery or pelvic pathology
* Use of hormonal treatments, contraceptives, or antidepressant medications
* Irregular menstrual cycles
* Pregnancy or history of childbirth
* Diagnosis of chronic pain due to other causes (e.g., fibromyalgia, endometriosis)
* Regular engagement in physical exercise or yoga practice in the past 3 months
* Any condition that may contraindicate moderate-intensity physical activity

Primary outcomes:
measure: Sleep Quality
timeFrame: Since the menstrual cycle length varies between 28-35 days Baseline, at the end of Menstrual Cycle 2 (approximately Day 56-70), and at the end of Menstrual Cycle 3 (approximately Day 84-105)
measure: Aerobic Endurance
timeFrame: Since the menstrual cycle length varies between 28-35 days Baseline and at the end of Menstrual Cycle 3 (approximately Day 84-105)
measure: Aerobic Endurance
timeFrame: Since the menstrual cycle length varies between 28-35 days Baseline and at the end of Menstrual Cycle 3 (approximately Day 84-105)]
Secondary outcomes:
measure: Menstrual Pain Intensity
timeFrame: Since the menstrual cycle length varies between 28-35 days Baseline, at the end of Menstrual Cycle 2 (approximately Day 56-70), and at the end of Menstrual Cycle 3 (approximately Day 84-105)
measure: Menstrual Symptom Severity
timeFrame: Since the menstrual cycle length varies between 28-35 days Baseline and at the end of Menstrual Cycle 3 (approximately Day 84-105)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Saglik Bilimleri Universitesi
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Seda Bicici Ulusahin
role: PRINCIPAL_INVESTIGATOR
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