Yoga Effects in Primary Dysmenorrhea

NCT07020338 | Completed

• 1 other identifier: 2024-510
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Dysmenorrhea

Keywords

Primary dysmenorrhea; Yoga; Menstrual symptoms; Sleep quality; aerobic endurance

Outcome Measures

Primary Outcomes (3)

• 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)

  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)

• Aerobic Endurance

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

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

• 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)

  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)

• Menstrual Pain Intensity

  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)

• Menstrual Symptom Severity

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

Study Arms (2)

Yoga Intervention

EXPERIMENTAL

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

Other: Yoga Exercise Program

Control Group

NO INTERVENTION

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

Interventions

Yoga Exercise Program 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

Yoga Intervention

Eligibility Criteria

• Age: 18 Years - 25 Years
• Gender Eligibility Details: Primary dysmenorrhea is a condition that occurs in individuals with a uterus and regular menstrual cycles-thus, only biologically female participants were eligible.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Saglik Bilimleri Universitesi

Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (14)

• 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.

  PMID: 10325892 BACKGROUND

• 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.

  PMID: 19149046 BACKGROUND

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

  PMID: 8276501 BACKGROUND

• 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.

  PMID: 29422741 BACKGROUND

• 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.

  PMID: 36472094 BACKGROUND

• 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.

  PMID: 25403347 BACKGROUND

• 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.

  PMID: 23647406 BACKGROUND

• 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.

  PMID: 22808932 BACKGROUND

• 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.

  PMID: 27315239 BACKGROUND

• 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.

  PMID: 22963270 BACKGROUND

• 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.

  PMID: 16690671 BACKGROUND

• 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.

  PMID: 26346058 BACKGROUND

• 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.

  PMID: 16880317 BACKGROUND

• 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.

  PMID: 24284871 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Seda Bicici Ulusahin

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT PhD

Model Details: 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).

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 13, 2025
• Study Start: January 15, 2025
• Primary Completion: May 25, 2025
• Study Completion: May 25, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)