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

5 sierpnia 2026 zaktualizowane przez: University of Lahore

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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

48

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan
        • The University of Lahore

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Core Stabilization Exercises
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.
Behawioralne: Core Stabilization Exercises

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.
Eksperymentalny: Breathing exercises combined with core stabilization exercises
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.
Behawioralne: Core Stabilization Exercises

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.

Behawioralne: Breathing Exercises Combined with Core Stabilization Exercises

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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change from Baseline in Menstrual Pain Intensity
Ramy czasowe: 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.
Baseline, Week 8

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change from Baseline in SF-12 Physical Component Summary Score
Ramy czasowe: 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.
Baseline, Week 8
Change from Baseline in SF-12 Mental Component Summary Score
Ramy czasowe: 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.
Baseline, Week 8
Change from Baseline in DASS-21 Depression Subscale Score
Ramy czasowe: 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.
Baseline, Week 8
Change from Baseline in DASS-21 Anxiety Subscale Score
Ramy czasowe: 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.
Baseline, Week 8
Change from Baseline in DASS-21 Stress Subscale Score
Ramy czasowe: 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.
Baseline, Week 8

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Lahore

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

  • Mustain M, Shela M, Tri Y, Witriani W, Hussein M, editors. The Effect of Deep Breathing Relaxation Techniques on Reducing Dysmenorrhea Pain in Adolescent Girls at The Indah 43 Dormitory in Cemani Village. Proceeding of International Conference on Science, Health, And Technology; 2024. 17. Chodon L, Samuel J. Lalramzawni (2024) Core Stability Exercise on Low Back Ache, Back Endurance and Health Related Quality of Life in Primary Dysmenorrhea-A Single Group Experimental Study. Indian Journal of Science and Technology. 2024;17(24):2494-8. . Martire FG, Piccione E, Exacoustos C, Zupi E. Endometriosis and adolescence: the impact of dysmenorrhea. Journal of clinical medicine. 2023;12(17):5624. . Itani R, Soubra L, Karout S, Rahme D, Karout L, Khojah HM. Primary dysmenorrhea: pathophysiology, diagnosis, and treatment updates. Korean journal of family medicine. 2022;43(2):101.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

18 października 2025

Zakończenie podstawowe (Rzeczywisty)

20 grudnia 2025

Ukończenie studiów (Rzeczywisty)

15 kwietnia 2026

Daty rejestracji na studia

Pierwszy przesłany

24 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

5 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

7 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

7 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

5 sierpnia 2026

Ostatnia weryfikacja

1 listopada 2025

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • MSWH-PD-001

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

no plans to share IPD due to institutional policy and participants confidentiality.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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