The Effect of Manual Lymphatic Drainage and Transcutaneous Electrical Nerve Stimulation Methods in Women with Premenstrual Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- The Premenstrual Syndrome Scale (PMSS)
研究概览
简要总结
The aim of this study is to (a) investigate the effects of manual lymphatic drainage and transcutaneous electrical nerve stimulation on the severity of syndrome symptoms, pain, heart rate variability, and quality of life in women with premenstrual syndrome, and (b) compare the effectiveness of these two methods. Female participants who met the inclusion criteria and volunteered to participate in the study will be called approximately one week before menstruation. After the participants are randomly divided into 3 groups, their baseline assessments will be made. Then, the participants will be treated according to the group they are assigned to. Treatments will be applied for 5 days and once a day. No treatment will be applied to the control group. The assessments will be repeated after the treatment, on 1st day of menstruation, two days before the next menstruation, and on the first day of the next menstruation. The hypothesis of this study is that manual lymphatic drainage and transcutaneous electrical nerve stimulation have positive effects on the severity of premenstrual syndrome symptoms, pain, heart rate variability, and quality of life.
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)
盲法说明
The researcher who made the assessments and participants do not know which group participants belong to.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women aged between18-45 years-old
- •regular menstrual cycles (cycles of 21-35 days with a bleeding time of 3-10 days)
- •premenstrual syndrome (according to the premenstrual syndrome scale, be above 110 points)
排除标准
- •pregnancy
- •premenstrual dysphoric disorder
- •menopause
- •chronic disease
- •continuous use of medication
- •under hormonal therapy
- •infection
- •using any method to cope with premenstrual syndrome
结局指标
主要结局
The Premenstrual Syndrome Scale (PMSS)
时间窗: 1 month
PMSS will be used to measure the severity of premenstrual symptoms. The participant is asked to mark retrospectively, taking into account the "being within the period one week before the menstrual period". There are 44 items in the scale. The scale items have a five-point Likert type rating ranging from 1 to 5. The lowest score that can be obtained from the scale is 44, and the highest score is 220. A higher PMSS score indicates more severe premenstrual symptoms.
次要结局
- Heart rate and Heart rate variability(1 month)
- Short form of the World Health Organization Quality of Life Questionnaire (WHOQOL)(1 month)
- Visual analog scale (VAS) for pain levels(1 month)
研究者
Gamze Kurt
associate professor
Kutahya Health Sciences University