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临床试验/NCT06317532
NCT06317532尚未招募不适用

Effect of Functional Exercises on Pain and Quality of Life in Females With Primary Dysmenorrhea

Cairo University1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2024年3月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
58
试验地点
1
主要终点
Visual analogue scale (VAS)

研究概览

简要总结

The aim of the study will be to investigate the effect of functional exercises on pain and quality of life in females with primary dysmenorrhea.

详细描述

Primary dysmenorrhea and menstrual pain are significant health, social and economic problems. It involves a broad spectrum of physical and emotional manifestations, with 50% to 91 % prevalence in young women.

Women with primary dysmenorrhea report significantly lower quality of life because of bodily pain, general health condition, and physical and social functioning. It compromises the most common gynecological alternations and is the primary cause of women's academic and work absenteeism, which reduces the quality of life, daily activities, and economic situation due to decreased working hours.

Non-Steroidal Anti-Inflammatory Drugs are the first therapeutic line for primary dysmenorrhea; however, they might be accompanied by undesirable side effects, such as dyspepsia, headache, and drowsiness.

So, there is a need for safe interventions with no side effects. Therefore, this study aims to investigate the effects of functional exercises on pain and quality of life in females with 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
Double (Participant, 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

  • Their ages will be ranged from 18 to 25 years
  • They will be suffering from primary dysmenorrhea based on the Menstrual Distress questionnaire.
  • Their BMI will be ranged from 20 to 25 kg/m
  • Having regular menstrual cycles (one every 28-34 days).
  • They will be sedentary virgin females.
  • They are non-smokers.
  • They have not been in any exercise program for three months.

排除标准

  • Having secondary dysmenorrhea.
  • Using regular medication or contraceptive pills.
  • Having neuromuscular, metabolic, or cardiac diseases.
  • Having a preexisting condition prevents them from engaging in an exercise program.

研究组 & 干预措施

Lifestyle modification advice

Active Comparator

It will include 29 females suffering from primary dysmenorrhea. They will be asked to follow lifestyle modification advice during the program duration.

干预措施: Lifestyle modification advice (Other)

Lifestyle modification advice + Functional exercises

Experimental

It will include 29 females suffering from primary dysmenorrhea. They will be given the same lifestyle modification advice as group A, in addition to performing a combination of various functional exercises (including two stretching exercises, one yoga position, two core-strengthening exercises, two pelvic area exercises, and Kegel exercises), for 45 minutes per session, three times /week for eight weeks.

干预措施: Lifestyle modification advice (Other)

Lifestyle modification advice + Functional exercises

Experimental

It will include 29 females suffering from primary dysmenorrhea. They will be given the same lifestyle modification advice as group A, in addition to performing a combination of various functional exercises (including two stretching exercises, one yoga position, two core-strengthening exercises, two pelvic area exercises, and Kegel exercises), for 45 minutes per session, three times /week for eight weeks.

干预措施: Functional exercises (Other)

结局指标

主要结局

Visual analogue scale (VAS)

时间窗: 8 weeks

It will be used to measure pain intensity for each female in both groups (A\&B) before and after the end of treatment. The VAS is usually presented as a 10 cm horizontal line on which the participants' pain intensity is represented by a point between the extremes of "no pain at all "and "worst pain imaginable. " Its simplicity, reliability, and validity, as well as its ratio scale properties, make the VAS the optional tool for describing pain intensity.

The Menstrual Distress Questionnaire

时间窗: 8 weeks

It will be used to evaluate menstruation symptoms and distress for each female in both groups (A\&B) before and after the end of treatment. It consists of symptoms or feelings associated with menstruation. The total number of items is 47. It is a 5-point rating scale from 0-4. Each item has five options, i.e., No, mild, moderate, severe, and very severe. An option of (very severe) has a score of 4, (severe) has a score of 3, (moderate) has a score of 2, (mild) has a score of 1, (No) has a score of 0. It includes seven subscales as (pain, water retention, autonomic reactions, negative affect, impaired concentration, mood and behavioral changes, and arousal control). The overall score was interpreted as follows: \<50 - mild, 50 to 70 - moderate, and \>70 severe.

次要结局

  • Pressure pain threshold assessment(8 weeks)
  • Quality of life enjoyment and satisfaction questionnaire(8 weeks)

研究者

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

Manar Essam Al-Emary

Principal Investigator

Cairo University

研究点 (1)

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