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Primary DysmenorrheaNCT07020338

Yoga Effects in Primary Dysmenorrhea

A study testing Yoga Exercise Program in people with Primary Dysmenorrhea, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 25 years, women onlyHealthy volunteers can take part
Conditions the study is for
Primary Dysmenorrhea
What is being tested?
Yoga Exercise Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Jan 2025to 25 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 25 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Saglik Bilimleri Universitesi

    Ankara, 06010

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Yoga on Menstrual Symptoms, Pain, Sleep Quality, and Aerobic Endurance in Young Women With Primary Dysmenorrhea: A Randomized Controlled Trial

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:

Read more

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.

Read the 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.

Being tested
Yoga Exercise Program
Keywords
Primary dysmenorrhea, Yoga, Menstrual symptoms, Sleep quality, aerobic endurance
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Yoga Exercise ProgramOther

    Participants in the intervention group received a structured yoga-based exercise program consisting of 50-minute sessions, conducted twice per week over a period of approximately 10-12 weeks (three menstrual cycles). The program was based on Hatha Yoga principles

Study groups in NCT07020338
Study groupRoleWhat they receive
Yoga InterventionExperimentalParticipants in this group received a structured yoga program consisting of 50-minute sessions, twice per week, over three menstrual cycles.
Receives: Other: Yoga Exercise Program
Control GroupNo interventionParticipants in this group received no intervention during the study period but were offered the yoga program after completion of the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sleep Quality

    Change in sleep quality assessed using the Sleep Diary across three menstrual cycles. Includes measures such as sleep onset latency, total sleep time, number of awakenings, and subjective sleep quality.

    Measure Type: Continuous (sleep parameters in minutes and Likert-scale scores) Sleep Onset Latency (in minutes) Total Sleep Time (in minutes) Number of Awakenings (count) Subjective Sleep Quality (Scale 1-5)

    Measured: 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)

  2. Aerobic Endurance

    Change in aerobic endurance assessed via Incremental Shuttle Walk Test (ISWT) Measure Type: Continuous (distance in meters)

    Measured: Since the menstrual cycle length varies between 28-35 days Baseline and at the end of Menstrual Cycle 3 (approximately Day 84-105)

  3. Aerobic Endurance

    Change in aerobic endurance assessed by Endurance Shuttle Walk Test (ESWT). Time to exhaustion during the ESWT, used to assess submaximal aerobic endurance Measure Type: Continuous (minutes)

    Measured: 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 (2)
  1. Menstrual Pain Intensity

    . Pain severity will be assessed using a 100 mm Visual Analog Scale (VAS), where 0 mm indicates "no pain" and 100 mm indicates "worst imaginable pain." Measure Type: Continuous (VAS score in millimeters)Scores will be recorded during the first 3 days of menstruation across three menstrual cycles.

    Measured: 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)

  2. Menstrual Symptom Severity

    Menstrual symptoms will be assessed using the Menstrual Symptom Questionnaire (MSQ), a 24-item self-report scale evaluating the severity and frequency of physical and emotional symptoms related to menstruation. The total MSQ score is calculated by summing item responses. Higher scores indicate worse (more severe) menstrual symptoms Measure Type: Continuous (total MSQ score) / Score range: 0 to 96

    Measured: Since the menstrual cycle length varies between 28-35 days Baseline and at the end of Menstrual Cycle 3 (approximately Day 84-105)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2025
  2. Study start15 Jan 2025
  3. Primary completion25 May 2025
  4. Study completion25 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07020338
Sponsor's protocol ID
2024-510
Status last verified
Jun 2025
First submitted
26 May 2025
Last updated
13 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared due to privacy concerns and limitations in the consent obtained from participants.

Publications

  • Super M. Can manifesting heterozygotes have cystic fibrosis? Thorax. 1999 Mar;54(3):194-5. doi: 10.1136/thx.54.3.194. No abstract available.

    PubMed 10325892
  • Freedman G. Buyers' guide to dental lasers. Lasers entering into the mainstream of dentistry. Dent Today. 2008 Dec;27(12):92, 94, 96 passim. No abstract available.

    PubMed 19149046
  • Bera TK, Rajapurkar MV. Body composition, cardiovascular endurance and anaerobic power of yogic practitioner. Indian J Physiol Pharmacol. 1993 Jul;37(3):225-8.

    PubMed 8276501
  • Divya TS, Vijayalakshmi MT, Mini K, Asish K, Pushpalatha M, Suresh V. Cardiopulmonary and Metabolic Effects of Yoga in Healthy Volunteers. Int J Yoga. 2017 Sep-Dec;10(3):115-120. doi: 10.4103/0973-6131.186162.

    PubMed 29422741
  • Lopes TR, Pereira HM, Bittencourt LRA, Silva BM. How much does sleep deprivation impair endurance performance? A systematic review and meta-analysis. Eur J Sport Sci. 2023 Jul;23(7):1279-1292. doi: 10.1080/17461391.2022.2155583. Epub 2022 Dec 15.

    PubMed 36472094
  • Aboagye E, Karlsson ML, Hagberg J, Jensen I. Cost-effectiveness of early interventions for non-specific low back pain: a randomized controlled study investigating medical yoga, exercise therapy and self-care advice. J Rehabil Med. 2015 Feb;47(2):167-73. doi: 10.2340/16501977-1910.

    PubMed 25403347
  • Rani M, Singh U, Agrawal GG, Natu SM, Kala S, Ghildiyal A, Srivastava N. Impact of Yoga Nidra on menstrual abnormalities in females of reproductive age. J Altern Complement Med. 2013 Dec;19(12):925-9. doi: 10.1089/acm.2010.0676. Epub 2013 May 6.

    PubMed 23647406
  • Sakuma Y, Sasaki-Otomaru A, Ishida S, Kanoya Y, Arakawa C, Mochizuki Y, Seiishi Y, Sato C. Effect of a home-based simple yoga program in child-care workers: a randomized controlled trial. J Altern Complement Med. 2012 Aug;18(8):769-76. doi: 10.1089/acm.2011.0080. Epub 2012 Jul 18.

    PubMed 22808932
  • Yang NY, Kim SD. Effects of a Yoga Program on Menstrual Cramps and Menstrual Distress in Undergraduate Students with Primary Dysmenorrhea: A Single-Blind, Randomized Controlled Trial. J Altern Complement Med. 2016 Sep;22(9):732-8. doi: 10.1089/acm.2016.0058. Epub 2016 Jun 17.

    PubMed 27315239
  • Chien LW, Chang HC, Liu CF. Effect of yoga on serum homocysteine and nitric oxide levels in adolescent women with and without dysmenorrhea. J Altern Complement Med. 2013 Jan;19(1):20-3. doi: 10.1089/acm.2011.0113. Epub 2012 Sep 10.

    PubMed 22963270
  • Proctor M, Farquhar C. Diagnosis and management of dysmenorrhoea. BMJ. 2006 May 13;332(7550):1134-8. doi: 10.1136/bmj.332.7550.1134. No abstract available.

    PubMed 16690671
  • Iacovides S, Avidon I, Baker FC. What we know about primary dysmenorrhea today: a critical review. Hum Reprod Update. 2015 Nov-Dec;21(6):762-78. doi: 10.1093/humupd/dmv039. Epub 2015 Sep 7.

    PubMed 26346058
  • Dawood MY. Primary dysmenorrhea: advances in pathogenesis and management. Obstet Gynecol. 2006 Aug;108(2):428-41. doi: 10.1097/01.AOG.0000230214.26638.0c.

    PubMed 16880317
  • Ju H, Jones M, Mishra G. The prevalence and risk factors of dysmenorrhea. Epidemiol Rev. 2014;36:104-13. doi: 10.1093/epirev/mxt009. Epub 2013 Nov 26.

    PubMed 24284871

Questions about this trial

What is this clinical trial studying?

A study testing Yoga Exercise Program in people with Primary Dysmenorrhea, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep Quality (time frame: 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07020338, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.

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