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Completed

NCT Number: NCT05340816

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

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.

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Key information

Conditions

Premenstrual Syndrome Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kutahya Health Sciences University- Health Sciences Faculty

Kütahya, 43000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual lymphatic drainage

Other

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.

Transcutaneous electrical nerve stimulation

Device

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.

Primary outcomes

  1. 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

  1. Heart rate and Heart rate variability

    Time frame: 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.

  2. Visual analog scale (VAS) for pain levels

    Time frame: 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.

  3. Short form of the World Health Organization Quality of Life Questionnaire (WHOQOL)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Apr 22, 2022
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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