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临床试验/NCT06615258
NCT06615258已完成不适用

Investigation of the Effect of Breathing-based Pelvic Floor Muscle Training on Menstrual Symptoms, Pain and Quality of Life in Women With Primary Dysmenorrhea: A Randomized-Controlled Trial

Izmir University of Economics2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
66
试验地点
2
主要终点
Change of Menstruation Symptom Scale score

研究概览

简要总结

Primary dysmenorrheic (PD) pain usually begins during adolescence, at menarche or shortly after (6-24 months), and has a clear and predictable temporal pattern. The pain typically radiates to the back and thighs and lasts for 8-72 hours. The pain is most severe on the first and/or second day of menstrual bleeding. Additionally, systemic symptoms such as nausea, vomiting, diarrhea, fatigue, and insomnia often accompany the pain. In secondary dysmenorrhea, it can result from a range of identifiable pathological conditions, including endometriosis, adenomyosis, fibroids, and pelvic inflammatory disease. Other gynecological symptoms such as intermenstrual bleeding and menorrhagia may also accompany it, depending on the underlying condition. Empirical treatment approaches have been reported as appropriate for patients with primary dysmenorrhea based on symptoms and physical examination results. Recent studies have indicated that during diaphragmatic breathing, all the muscles that make up the thoracic and abdominal walls should expand in a cylindrical manner in all directions through synchronized eccentric activity. Thus, a more effective result will occur with the concentric contraction and 360-degree expansion of the diaphragm during inspiration, which raises intra-abdominal pressure .

Within the framework of this information, the aim of this study is to examine the effects of respiration-based physiotherapy approaches on menstrual symptoms, pain, and quality of life in women with PD.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Aged between 18-35,
  • Voluntary participation,
  • Having a regular menstrual cycle (every 24-35 days) ,
  • Menstrual pain intensity of 3/10 or higher on the Visual Analog Scale during the initial assessment,
  • Pain radiating to the back, legs, lower abdominal, or suprapubic region during menstruation,
  • Restriction of daily living activities due to pain,
  • Requirement for medical intervention or self-medication to control the pain.

排除标准

  • History of pelvic pathology and/or surgery that could cause pain,
  • Neurological or psychological disorders,
  • Anovulation,
  • Other diseases that could affect chest expansion or the respiratory system (COPD, asthma, pneumonia, bronchiectasis, etc.),
  • Being pregnant, having a positive birth control status, or being less than 6 months postpartum,
  • Use of an intrauterine device,
  • History of childbirth or miscarriage. Individuals who miss two consecutive exercise sessions will be excluded from the study.

结局指标

主要结局

Change of Menstruation Symptom Scale score

时间窗: 4 weeks after the intervention

Individuals menstrual pain and symptoms will be assessed with the Menstruation Symptom Scale. The Turkish validity and reliability of this scale was conducted by Güvenç et al. in 2014. The MSS is a five-point Likert-type scale consisting of twenty-two items. Participants are asked to give a number between 1 (never) and 5 (always) to the symptoms they experience related to menstruation. The scale has three sub-dimensions: 'Negative Effects/Somatic Complaints' (Items 1-13), 'Menstrual Pain Symptoms' (Items 14-19) and 'Coping Methods' (Items 20-22). The highest score that can be obtained from the scale is 110, the lowest score is 22.

Change in the McGill pain questionnaire score

时间窗: 4 weeks after the intervention

The McGill pain questionnaire will be used to assess the severity and quality of menstrual pain in individuals. This questionnaire consists of 11 words to determine the sensory aspect of pain and 4 words to determine the affective aspect, totaling 15 different words related to the quality of pain. In addition, the pain intensity felt at the time of measurement is measured with VAS, and the total pain intensity evaluated is measured with a 6-point Likert-type scale.

次要结局

  • Change of Menstruation Symptom Scale score(3 months after the intervention)
  • Change of Quality of Life score(3 months after the intervention)
  • Change in the McGill pain questionnaire score(3 months after the intervention)

研究者

发起方
Izmir University of Economics
申办方类型
Other
责任方
Principal Investigator
主要研究者

Seda Yakit Yesilyurt

Assistant Prof.

Izmir University of Economics

研究点 (2)

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