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临床试验/NCT05340101
NCT05340101Unknown不适用

Effect of Progressive Muscle Relaxation Exercise on Primary Dysmenorrhea Menstrual Symptoms and Quality of Life. Randomized Controlled Study

Gazi University2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2022年4月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
42
试验地点
2
主要终点
change difference primary dysmenorrhea of the groups

研究概览

简要总结

In this study, it was aimed to evaluate the effect of progressive muscle relaxation exercise on dysmenorrhea, menstrual symptoms and quality of life in university students with common primary dysmenorrhea. The research is a single center, parallel group block randomized controlled experimental study. This study will be conducted in the Department of Nursing, Faculty of Health Sciences, of a state university in Turkey. The universe of the research will be Gazi University Faculty of Health Sciences, third year and last year nursing students (N: 451). In order to determine the sample size in the research, power analysis was performed using the G Power 3.1.0 program. For this purpose, the study results of Sis Çelik and Ejder Apay (2021), which were similar to our study, were taken as reference. According to the power analysis made by calculating the effect size; It was determined that the sample of the study should consist of a total of 42 people, 21 in each group, will be randomized.

The data of the research; Personal information form will be collected using Visual Analogue Scale (VAS), SF-12 Quality of Life Scale Short Form, Menstrual Symptom Scale, Dysmenorrhea Monitoring Form. The implementation of the research is planned between April 15, 2022 and August 15, 2022. Third and fourth year nursing students will be included in the study. First of all, it will be evaluated according to the sampling inclusion criteria using the pre-evaluation form. Women who meet the inclusion criteria will be informed about the purpose and importance of the research, and women who agree to participate in the study will be determined. Informed consent form will be signed by the women who accepted to participate in the study, Visual Analogue Scale, Menstrual Symptom Scale and SF 12 Short Form will be applied. Randomization will be done after obtaining consent and filling out the forms.

详细描述

Non-pharmacological methods include body therapies, mind-body based therapies, Chinese herbal medicine and vitamin mineral supplements. In particular, physical exercises, acupuncture, aromatherapy, Chinese herbal medicine and yoga are non-pharmacological methods frequently used in the management of dysmenorrhea. Progressive muscle relaxation exercise (PMRE), one of the mind-body based therapies, is frequently used in pain management, but there are limited studies on its effect on primary dysmenorrhea. Progressive muscle relaxation exercise focuses on recognizing muscle tension and then reducing this tension. Studies conducted in different populations have found that progressive muscle relaxation exercise reduces pain and improves quality of life.

There is insufficient evidence for the effect of progressive muscle relaxation exercises in the management of primary dysmenorrhea. Therefore, in this study, it was aimed to evaluate the effect of progressive muscle relaxation exercise on dysmenorrhea, menstrual symptoms and quality of life in university students with common primary dysmenorrhea.

METHOD Type of Research The research is a single center, parallel group block randomized controlled experimental study.

Location and Characteristics of the Research This study will be conducted in the Department of Nursing, Faculty of Health Sciences, of a state university in Turkey.

Population and Sample of the Research The universe of the research will be Gazi University Faculty of Health Sciences, third year and last year nursing students (N: 451). In order to determine the sample size in the research, power analysis was performed using the G Power 3.1.0 program. For this purpose, the study results of Sis Çelik and Ejder Apay (2021), which were similar to our study, were taken as reference. According to the power analysis made by calculating the effect size; It was determined that the sample of the study should consist of a total of 24 participants, 12 in the intervention group and 12 in the control group (α=0.05, 1-β =0.99, Effect size d= 1.9111974, tail(s)=two). Considering the drop out rate of the study as 36%, a total of 42 people, 21 in each group, will be randomized.

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
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • Inclusion criteria for the study;
  • Having primary dysmenorrhea,
  • Being Nulligravida,
  • Having a history of regular menstrual cycles in the last six months (cycle duration 21-35 days),
  • Not using hormonal contraceptives,
  • A score of 5 or more on the visual analog scale (VAS).
  • Not to have metabolic disease, cancer, heart disease and diabetes, diagnosed psychiatric disease, and not using antidepressant medication that would prevent him from performing PCGE.
  • Not doing any other body-mind based practice
  • Using a smartphone
  • Not having any communication problems (mental, auditory, visual, etc.)
  • To be willing to participate in the study. Exclusion criteria,
  • Use of complementary therapies, anti-inflammatory therapy, antidepressants or anxiolytics during the study
  • Occurrence of menstrual cycle irregularity
  • Performing PKGE 3 times a week or less in a row

排除标准

  • 未提供

结局指标

主要结局

change difference primary dysmenorrhea of the groups

时间窗: 8 weeks

Visual Analog Scale

change difference between the menstrual symptom scale scores of the groups

时间窗: 8 weeks

menstrual symptom scale

次要结局

未报告次要终点

研究者

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

Sidika Pelit Aksu

Research asistant (RN)

Gazi University

研究点 (2)

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