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临床试验/NCT04451629
NCT04451629Unknown不适用

Effect of Exercise on Pain and Qulity of Life on People in Primary Dysmenorrhea Complaints

SİNEM BAĞCI1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
Visual Analogue Scale (pain intensity)

研究概览

简要总结

Dismenored that menstruation is painful enough to interfere with the normal activity of the individual and require drug use. Dysmenorrhea is a localized pain in the lower abdominal quadrant and may spread to the back, waist, groin and vulva. This periodic pain may be accompanied by GIS complaints such as nausea, vomiting and frequent defecation, headache, emotional disorders and palpitations. Primary dysmenorrhea manifests itself as painful cramps in the lower part of the abdomen during the menstruation period without a pelvic pathology (endometriosis, pelvic adhesion or uterine fibroids, etc.). Menstrual problems affect 75% of adolescent girls and cause widespread medical treatment. The prevalence of primary dysmenorrhea in adolescents is significantly high, which is reported to be a major public health problem requiring attention. When Dysmenorrhea prevalence by examining the situation regarding in Turkey is noteworthy that dysmenorrhea prevalence in the 34-% 89.6% range. Non-drug applications are frequently used in the management of primary dysmenorrhea . Often, exercise is seen as an important method among these practices. Often, exercise is seen as an important method among these practices.

It has been reported that the effect of regular exercise on dysmenorrhea may be due to the effect of hormonal changes on the epithelial tissue of the uterus or an increase in endorphin levels, and it is concluded that dysmenorrhea reduces symptoms The aim of this study was to determine the effectiveness of pelvic floor exercise and quality of life in reducing pain in adolescents with primary dysmenorrhea.

详细描述

Research; planned as randomized controlled. The research is planned to be carried out in a faculty of Nursing, which provides service with 1 department of a university with 38.482 student capacity, continuing education with 15 faculties, 1,600 academic 1.152 administrative staff in the city center of Konya.

The population of the study is all female students who have been studying since 2018-2019 academic year. The population of the study is all female students who have been studying since 2018-2019 academic year.

The sample size of the study will be composed of female students who have the complaint of dysmenorrhea as a result of the pre-test and who agree to participate in the study.

The power analysis was used to determine the number of cases that required pelvic floor exercise and control groups for the study. In the study of Gamit et al., It was accepted that the mean pain decreased from 6.10 (1 ± 35) to 4.6 with a 1.5 decrease. Considering the data losses to be experienced during the study, 30 female patients were planned to be included in each group (Potur and Kömürcü 2014).

Working Group: Before randomization, Dismenorrhea Diagnosis Form will be applied to women students who agree to participate in the study according to the sample selection criteria and general information about the study will be given and their general consent will be obtained for participation in the study. In accordance with the sample size determined by power analysis, random assignment to experimental and control groups will be made. Block randomization system will be used.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Parallel Assignment a experimental design with pre test and post test

入排标准

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

入选标准

  • •Describe dysmenorrhea pain severity as five and above on the visual comparison scale in the form of diagnosis of dysmenorrhea,
  • •Being single,
  • •Regular menstruation for the last 6 months (every 21-35 days with no intermittent bleeding),
  • •Body Mass Index (BMI) is between 19-29,
  • •19-25 years of age
  • •Voluntary acceptance of participation in the study

排除标准

  • •Having systemic and chronic diseases,
  • •Physical disability,
  • •Professional athlete,
  • •Using hormonal contraception (such as oral contraceptives and injections) and IUD,
  • •Secondary dysmenorrhea pathology (ultrasound examinations will be performed by a gynecologist).

研究组 & 干预措施

Exercises group

Experimental

intervention group çalışma grubundaki kadın öğrencilere 8 hafta süresince haftada 4 kez 40 dakika boyunca pelvik taban ve core egzersizleri uygulatılacak

干预措施: pelvıc base exercıse, core exercise (Behavioral)

control group

No Intervention

students will be watched without any intervention

结局指标

主要结局

Visual Analogue Scale (pain intensity)

时间窗: 8 weeks

Patients will be asked to keep a diary with VAS to determine the severity of pain during menstruation. Patients will be asked to mark their degree of pain on a horizontal line of 100 millimeters (mm). 0: no pain, 10: maximum means more pain than can be tolerated. The point marked on the line will be measured with a ruler and recorded as the pain intensity in cm during the menstruation. Patients will be asked to mark their pain on a separate scale for each day of menstruation. Cases will mark the most severe pain during the day during menstruation on the Visual Analogue Scale (VAS) during the 3 menstrual cycles in which the study is being conducted.8 weeks of application will be done and 3 cycle will be followed

次要结局

  • Quality of Life Questionnaire(short form-36)(SF-36)(8 weeks)

研究者

发起方
SİNEM BAĞCI
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

SİNEM BAĞCI

Principal Investigator

Necmettin Erbakan University

研究点 (1)

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