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Clinical Trials/NCT05340816
NCT05340816
Completed
N/A

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

Kutahya Health Sciences University1 site in 1 country42 target enrollmentApril 4, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Premenstrual Syndrome
Sponsor
Kutahya Health Sciences University
Enrollment
42
Locations
1
Primary Endpoint
The Premenstrual Syndrome Scale (PMSS)
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 4, 2022
End Date
February 15, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Kutahya Health Sciences University
Responsible Party
Principal Investigator
Principal Investigator

Gamze Kurt

associate professor

Kutahya Health Sciences University

Eligibility Criteria

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

Outcomes

Primary Outcomes

The Premenstrual Syndrome Scale (PMSS)

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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