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

Not Applicable

Completed

• Conditions: Premenstrual Syndrome
• Interventions: Other: Manual Lymphatic Drainage; Device: Transcutaneous Electrical Nerve Stimulation

• Registration Number: NCT05340816
• Lead Sponsor: Kutahya Health Sciences University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-04
• Study First Submitted: 2022-04-06
• Study First Submitted QC: 2022-04-16
• Study First Posted: 2022-04-22
• Primary Completion: 2023-12-31
• Study Completion: 2024-02-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual Lymphatic Drainage	Manual Lymphatic Drainage	5 days, 30 minutes, Manual Lymphatic Drainage
Transcutaneous Electrical Nerve Stimulation	Transcutaneous Electrical Nerve Stimulation	5 days, 20 minutes, Transcutaneous Electrical Nerve Stimulation

Primary Outcome Measures

Name	Time	Method
The Premenstrual Syndrome Scale (PMSS)	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 Outcome Measures

Name	Time	Method
Heart rate and Heart rate variability	1 month	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.
Short form of the World Health Organization Quality of Life Questionnaire (WHOQOL)	1 month	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.
Visual analog scale (VAS) for pain levels	1 month	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.

Trial Locations

Locations (1)

Kutahya Health Sciences University- Health Sciences Faculty; 🇹🇷 Kütahya, Turkey