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Completed

NCT Number: NCT07753408

Breathing Exercises Combined With Core Stabilization Exercises in Women With Primary Dysmenorrhea

Primary dysmenorrhea is a common gynecological condition among women of reproductive age and is associated with pelvic pain, psychological distress, and reduced health-related quality of life. Although core stabilization exercises and breathing exercises have individually demonstrated beneficial effects, evidence regarding their combined effectiveness remains limited.

This randomized controlled trial aims to compare the effects of core stabilization exercises alone with breathing exercises combined with core stabilization exercises in women with primary dysmenorrhea. Forty-eight women aged 18-25 years will be randomly allocated to either the control group (core stabilization exercises) or the experimental group (breathing exercises combined with core stabilization exercises). Both groups will participate in supervised exercise sessions three times per week for eight weeks.

Outcome measures will include menstrual pain intensity, psychological status, and health-related quality of life, assessed using the Visual Analog Scale (VAS), Depression Anxiety Stress Scales-21 (DASS-21), and 12-Item Short Form Health Survey (SF-12) at baseline and Week 8.

The study will determine whether adding breathing exercises to core stabilization exercises provides greater clinical benefits than core stabilization exercises alone.

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Key information

Conditions

Primary Dysmenorrhea (PD)

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Lahore

Lahore, Punjab Province, Pakistan

About this study

Primary dysmenorrhea is one of the most common gynecological disorders affecting women of reproductive age and is characterized by recurrent menstrual pain that negatively affects physical, psychological, and social well-being. Exercise-based physiotherapy interventions have demonstrated beneficial effects in reducing pain and improving function; however, evidence regarding the combined use of breathing exercises and core stabilization exercises remains limited.

This randomized controlled trial is designed to compare the effectiveness of breathing exercises combined with core stabilization exercises versus core stabilization exercises alone in women with primary dysmenorrhea. A total of 48 eligible women aged 18-25 years will be randomly assigned to one of two groups.

The control group will receive core stabilization exercises, while the experimental group will receive breathing exercises combined with core stabilization exercises. Both groups will attend supervised exercise sessions three times per week for eight weeks.

Outcome measures will be assessed at baseline and Week 8. Menstrual pain intensity will be measured using the Visual Analog Scale (VAS), psychological status using the Depression Anxiety Stress Scales-21 (DASS-21), and health-related quality of life using the 12-Item Short Form Health Survey (SF-12).

Data will be analyzed using SPSS version 26. Independent-samples t-tests, paired-samples t-tests, and repeated-measures ANOVA will be used to compare outcomes within and between groups. The findings of this study will determine whether adding breathing exercises to core stabilization exercises provides greater improvements in pain intensity, psychological status, and quality of life than core stabilization exercises alone.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female participants aged 18-25 years.
  • Clinical diagnosis of primary dysmenorrhea confirmed through medical history or self-report.
  • Baseline menstrual pain intensity of 4 or higher on the Visual Analog Scale (VAS).
  • Willing to participate and provide written informed consent.
  • Agree not to receive any additional treatment for dysmenorrhea during the study period.

Exclusion criteria

  • Secondary dysmenorrhea caused by conditions such as endometriosis, adenomyosis, or uterine fibroids.
  • Pregnancy or childbirth within the previous six months.
  • Diagnosed pelvic floor disorders or chronic pelvic pain syndrome.
  • Severe psychological disorders or chronic pain conditions that may interfere with outcome assessment.
  • Premenstrual Dysphoric Disorder (PMDD).
  • History of pelvic surgery within the previous 12 months.

Treatment and study plan

Core Stabilization Exercises

Behavioral

Participants will perform a supervised core stabilization exercise program designed to improve trunk muscle strength, core stability, and pelvic stability. The intervention will be delivered three times per week for eight weeks, with each session lasting approximately 40 minutes.

Each session will begin with a 5-minute warm-up consisting of marching in place, torso rotations, side bends, cat-cow stretching, and hip circles.

The exercise program includes bicycle crunches (3 sets × 15 repetitions), abdominal curls (3 sets × 15 repetitions), standing trunk rotations (3 sets × 15 repetitions), side bends (3 sets × 15 repetitions), pelvic bridging (3 sets × 15 repetitions), and mountain climbers (3 sets × 15 repetitions). Rest intervals of 10-20 seconds will be provided between exercises.

Breathing Exercises Combined with Core Stabilization Exercises

Behavioral

Participants will receive supervised breathing exercises combined with the standard core stabilization exercise program. The intervention will be delivered three sessions per week for eight weeks, with each session lasting approximately 40 minutes.

The breathing exercise component will last approximately 8 minutes and will include the following techniques:

  • Diaphragmatic Breathing: Participants will inhale deeply through the nose while allowing the abdomen to expand and then exhale slowly through the mouth.
  • 4-7-8 Breathing: Participants will inhale through the nose for 4 seconds, hold their breath for 7 seconds, and exhale slowly through the mouth for 8 seconds.
  • Alternate Nostril Breathing (Nadi Shodhana): Participants will perform alternate nostril breathing by inhaling and exhaling through alternate nostrils in a controlled sequence.
  • Guided Relaxation with Slow Breathing: Participants will perform slow, controlled breathing while focusing on whole-body relaxation.

The breat

Primary outcomes

  1. Change from Baseline in Menstrual Pain Intensity

    Time frame: Baseline, Week 8

    Menstrual pain intensity assessed via the Visual Analog Scale (VAS). Scores range from 0 mm to 100 mm. Higher scores indicate greater pain intensity.

Secondary outcomes

  1. Change from Baseline in SF-12 Physical Component Summary Score

    Time frame: Baseline, Week 8

    Physical health-related quality of life assessed via the SF-12 Physical Component Summary (PCS) score. Scores range from 0 to 100. Higher scores indicate better physical health.

  2. Change from Baseline in SF-12 Mental Component Summary Score

    Time frame: Baseline, Week 8

    Mental health-related quality of life assessed via the SF-12 Mental Component Summary (MCS) score. Scores range from 0 to 100. Higher scores indicate better mental health.

  3. Change from Baseline in DASS-21 Depression Subscale Score

    Time frame: Baseline, Week 8

    Depression symptoms assessed via the Depression subscale of the DASS-21. Scores range from 0 to 42. Higher scores indicate greater severity of depressive symptoms.

  4. Change from Baseline in DASS-21 Anxiety Subscale Score

    Time frame: Baseline, Week 8

    Anxiety symptoms assessed via the Anxiety subscale of the DASS-21. Scores range from 0 to 42. Higher scores indicate greater severity of anxiety symptoms.

  5. Change from Baseline in DASS-21 Stress Subscale Score

    Time frame: Baseline, Week 8

    Stress symptoms assessed via the Stress subscale of the DASS-21. Scores range from 0 to 42. Higher scores indicate greater severity of stress symptoms.

Sponsors and collaborators

Lead sponsor

University of Lahore

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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