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Clinical Trials/NCT07753408
NCT07753408CompletedNot Applicable

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

University of Lahore1 site in 1 country48 target enrollmentStarted: October 18, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
48
Locations
1
Primary Endpoint
Change from Baseline in Menstrual Pain Intensity

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 25 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Core Stabilization Exercises

Active Comparator

Participants assigned to the control group will receive supervised core stabilization exercises three times per week for eight weeks. Each treatment session will last approximately 40 minutes.

Intervention: Core Stabilization Exercises (Behavioral)

Breathing exercises combined with core stabilization exercises

Experimental

Participants assigned to the experimental group will receive breathing exercises combined with the same core stabilization exercise program as the control group. Treatment sessions will be conducted three times per week for eight weeks, with each session lasting approximately 40 minutes.

Intervention: Core Stabilization Exercises (Behavioral)

Breathing exercises combined with core stabilization exercises

Experimental

Participants assigned to the experimental group will receive breathing exercises combined with the same core stabilization exercise program as the control group. Treatment sessions will be conducted three times per week for eight weeks, with each session lasting approximately 40 minutes.

Intervention: Breathing Exercises Combined with Core Stabilization Exercises (Behavioral)

Outcomes

Primary Outcomes

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

  • Change from Baseline in SF-12 Physical Component Summary Score(Baseline, Week 8)
  • Change from Baseline in SF-12 Mental Component Summary Score(Baseline, Week 8)
  • Change from Baseline in DASS-21 Depression Subscale Score(Baseline, Week 8)
  • Change from Baseline in DASS-21 Anxiety Subscale Score(Baseline, Week 8)
  • Change from Baseline in DASS-21 Stress Subscale Score(Baseline, Week 8)

Investigators

Sponsor
University of Lahore
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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