Yoga Effects in Primary Dysmenorrhea

NCT ID: NCT07020338

Last Updated: 2025-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-15

Study Completion Date

2025-05-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Dysmenorrhea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Yoga Intervention

Participants in this group received a structured yoga program consisting of 50-minute sessions, twice per week, over three menstrual cycles.

Group Type EXPERIMENTAL

Yoga Exercise Program

Intervention Type OTHER

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

Control Group

Participants in this group received no intervention during the study period but were offered the yoga program after completion of the study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Yoga Exercise Program

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Saglik Bilimleri Universitesi

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Seda Uluşahin

PT PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Seda Bicici Ulusahin

Role: PRINCIPAL_INVESTIGATOR

Saglik Bilimleri Universitesi

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Saglik Bilimleri Universitesi

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 10325892 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19149046 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 8276501 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29422741 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36472094 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25403347 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23647406 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22808932 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27315239 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22963270 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16690671 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26346058 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16880317 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24284871 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024-510

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Yoga for Adolescents
NCT04658563 COMPLETED NA