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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05340816
Enrollment
42
Registered
2022-04-22
Start date
2022-04-04
Completion date
2024-02-15
Last updated
2025-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premenstrual Syndrome

Keywords

Manual Lymphatic Drainage, Transcutaneous Electrical Nerve Stimulation, Premenstrual Syndrome, Quality of Life, Autonomic Functions

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.

Interventions

OTHERManual Lymphatic Drainage

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.

DEVICETranscutaneous Electrical Nerve Stimulation

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.

Sponsors

Kutahya Health Sciences University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

The researcher who made the assessments and participants do not know which group participants belong to.

Intervention model description

Participants will be assigned to manual lymph drainage, transcutaneous electrical nerve stimulation, or a control group.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The Premenstrual Syndrome Scale (PMSS)1 monthPMSS 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

MeasureTime frameDescription
Heart rate and Heart rate variability1 monthHeart 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.
Visual analog scale (VAS) for pain levels1 monthThe 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.
Short form of the World Health Organization Quality of Life Questionnaire (WHOQOL)1 monthWHOQOL 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026