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临床试验/NCT07753408
NCT07753408已完成不适用

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

University of Lahore1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年10月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
1
主要终点
Change from Baseline in Menstrual Pain Intensity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: 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.

干预措施: 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.

干预措施: Breathing Exercises Combined with Core Stabilization Exercises (Behavioral)

结局指标

主要结局

Change from Baseline in Menstrual Pain Intensity

时间窗: 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.

次要结局

  • 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)

研究者

发起方
University of Lahore
申办方类型
Other
责任方
Sponsor

研究点 (1)

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