The Effects of Manual Lymphatic Drainage and Transcutaneous Electrical Nerve Stimulation in Premenstrual Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Manual Lymphatic Drainage and Transcutaneous Electrical Nerve Stimulation Methods in Women With Premenstrual Syndrome

Conditions
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Premenstrual Syndrome

Intervention / Treatment
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* Other: Manual Lymphatic Drainage
* Device: Transcutaneous Electrical Nerve Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: pregnancy premenstrual dysphoric disorder menopause chronic disease continuous use of medication under hormonal therapy infection using any method to cope with premenstrual syndrome

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be assigned to manual lymph drainage, transcutaneous electrical nerve stimulation, or a control group.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manual Lymphatic Drainage<br>5 days, 30 minutes, Manual Lymphatic Drainage | Other: Manual Lymphatic Drainage<br>* Manual lymphatic drainage will apply to the neck, abdominal, bilateral inguinal lymph nodes, bilateral anterior/posterior thighs, and lumbal area. Treatment duration will be approximately 30 minutes for 5 days.<br>|
| Experimental: Transcutaneous Electrical Nerve Stimulation<br>5 days, 20 minutes, Transcutaneous Electrical Nerve Stimulation | Device: Transcutaneous Electrical Nerve Stimulation<br>* Transcutaneous electrical nerve stimulation will be apply to abdominal and lumbal area as 100 Hz and 100 msn. Treatment duration will be approximately 20 minutes for 5 days.<br>|
| No Intervention: Control<br>no any intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Premenstrual Syndrome Scale (PMSS) | 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. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate and Heart rate variability | Heart rate (HR) is the speed of the heartbeat measured by the number of contractions (beats) of the heart per minute. Heart rate variability (HRV) is the physiological phenomenon of variation in the time interval between heartbeats. It is measured by the variation in the beat-to-beat interval. A heart rate sensor will be used to evaluate HR and HRV. | 1 month | 
| Visual analog scale (VAS) for pain levels | The VAS will use to assess the participants' pain levels. In the VAS, patients are asked to mark the severity of their pain on a scale from 0 to 10. The VAS ranges from '0' representing no pain and '10' representing the worst pain. | 1 month | 
| Short form of the World Health Organization Quality of Life Questionnaire (WHOQOL) | WHOQOL will be used to assess quality of life.WHOQOL-BREF consists of four sub-dimensions (physical health, psychological health, social relations, and environment) and a total of 27 questions. Participants are asked to answer considering the last 15 days. Each question is scored between 1 and 5, and higher scores on the sub-dimensions indicate better quality of life. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Manual Lymphatic Drainage, Transcutaneous Electrical Nerve Stimulation, Premenstrual Syndrome, Quality of Life, Autonomic Functions