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.
Přehled studie
Postavení
Podmínky
Detailní popis
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 studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Punjab Province
-
Lahore, Punjab Province, Pákistán
- The University of Lahore
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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.
|
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. |
|
Experimentální: 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.
|
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. 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:
The breat |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change from Baseline in Menstrual Pain Intensity
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change from Baseline in SF-12 Physical Component Summary Score
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- MSWH-PD-001
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .