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临床试验/NCT07525102
NCT07525102已完成不适用

Effect of Progressive Relaxation Versus Isometric Exercises in Management of Primary Dysmenorrhea

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月11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
入组人数
60
试验地点
1
主要终点
Assessment of pain severity

研究概览

简要总结

This study will be conducted to compare the effect of progressive relaxation and isometric exercises in management of primary dysmenorrhea.

详细描述

The prevalence of dysmenorrhea varies between 16% and 91% in women of reproductive age, with severe pain in 2%-29% of the women studied. It has major implications for quality of life, such as limitation of daily activities and psychological stress, being one of the main causes of work absenteeism. Despite the significant effects on quality of life, the prevalence of primary dysmenorrhea is considered to be underestimated because women frequently do not seek medical treatment because of the commonly held belief that pain is an expected part of menstruation.

The prolonged use of NSAIDs is also associated with cardiovascular, hepatic, and renal problems. Likewise, oral contraceptives are not free from side effects either, as they increase the frequency of bleeding, weight gain, and risk of venous thromboembolism. So, there is a need for emphasis on alternative methods of conservative treatment as non-pharmacological and non-invasive therapy, as it is safe and easy to use for obtaining relief from dysmenorrhea symptoms.

Progressive relaxation exercises have been proven to have an impact on decreasing dysmenorrhea pain when they are practiced on a regular basis. Isometric exercises are easy and safe for sedentary population as the protocol is non-invasive and implemented at low intensity, and they are widely used in rehabilitation settings. Also, it is inexpensive as no special facilities or equipment are required, and not time-consuming. Hence, isometric exercises seems to be an appropriate non-pharmacological method for reducing the pain intensity of primary dysmenorrhea.

So, this study is an attempt to increase the body of knowledge in the field of physical therapy, as it will be the first one to investigate the difference between the effect of progressive relaxation exercises and isometric exercises in management of primary dysmenorrhea.

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
Single (Outcomes Assessor)

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

  • The regularity of the menstrual cycle is 28 to 34 days.
  • All of them suffer from moderate and severe dysmenorrhea pain on visual analogue scale.
  • Their BMI will be less than 30 kg\m2.

排除标准

  • Any pathological findings in the pelvic cavity as polycystic ovarian syndrome, endometriosis and pelvic inflammatory disease.
  • Any history of gynecological intervention.
  • Secondary dysmenorrhea.
  • Irregular menstruation

研究组 & 干预措施

Progressive Relaxation + Lifestyle modification advices

Experimental

It will consist of 20 participants with primary dysmenorrhea. They will receive progressive relaxation techniques three times per week, for 30 minutes once daily and will follow lifestyle modification advices for 3 consecutive menstrual cycles for 12 weeks.

干预措施: Progressive Relaxation Exercises (Other)

Progressive Relaxation + Lifestyle modification advices

Experimental

It will consist of 20 participants with primary dysmenorrhea. They will receive progressive relaxation techniques three times per week, for 30 minutes once daily and will follow lifestyle modification advices for 3 consecutive menstrual cycles for 12 weeks.

干预措施: Lifestyle modification advices (Behavioral)

Isometric Exercises + Lifestyle modification advices

Experimental

It will consist of 20 participants with primary dysmenorrhea. They will perform isometric exercises 5 days a week, two sessions a day, for 10 times per session and also followed lifestyle modification for 3 consecutive menstrual cycles for 12 weeks.

干预措施: Isometric Exercises (Other)

Isometric Exercises + Lifestyle modification advices

Experimental

It will consist of 20 participants with primary dysmenorrhea. They will perform isometric exercises 5 days a week, two sessions a day, for 10 times per session and also followed lifestyle modification for 3 consecutive menstrual cycles for 12 weeks.

干预措施: Lifestyle modification advices (Behavioral)

Lifestyle modification advices

Active Comparator

It will consist of 20 participants with primary dysmenorrhea. They will receive lifestyle modification advices for 12 weeks.

干预措施: Lifestyle modification advices (Behavioral)

结局指标

主要结局

Assessment of pain severity

时间窗: 12 weeks

Pain intensity will be assessed for all participants in the three groups before and after the intervention using the Visual Analog Scale (VAS). The VAS is a one-dimensional measure consisting of a 10 cm horizontal line representing a continuum from "no pain" to "worst imaginable pain." Participants will be instructed to mark a point on the line that best reflects their current pain intensity, and the score will be determined by measuring the distance from the "no pain" end.

Assessment of symptoms of dysmenorrhea

时间窗: 12 weeks

The Menstrual Distress Questionnaire (MDQ) will be used to assess symptom severity in all groups (A, B, and C) before and after treatment. Participants will rate their experience of each symptom on a scale ranging from no symptoms to severe or partially disabling symptoms. The MDQ consists of eight subscales: pain, impaired concentration, behavioral change, autonomic reactions, water retention, negative affect, arousal, and control. Symptoms are typically rated on a 4-point scale (0 = no symptoms to 3 = severe symptoms) or, in some versions, a 6-point scale. Subscale scores will be calculated by summing item ratings within each category, with higher scores indicating greater menstrual distress.

次要结局

  • Assessment of quality of life enjoyment and satisfaction(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aya Essam Abd Elmonem Ahmed

Principal Investigator

Cairo University

研究点 (1)

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