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

NCT05340816 | Completed

• 1 other identifier: PMS-1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Premenstrual Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Heart rate and Heart rate variability

  1 month

• Visual analog scale (VAS) for pain levels

  1 month

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

  1 month

Study Arms (3)

Manual Lymphatic Drainage

EXPERIMENTAL

5 days, 30 minutes, Manual Lymphatic Drainage

Other: Manual Lymphatic Drainage

Transcutaneous Electrical Nerve Stimulation

EXPERIMENTAL

5 days, 20 minutes, Transcutaneous Electrical Nerve Stimulation

Device: Transcutaneous Electrical Nerve Stimulation

Control

NO INTERVENTION

no any intervention

Interventions

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.

Manual Lymphatic Drainage

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.

Transcutaneous Electrical Nerve Stimulation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• pregnancy
• premenstrual dysphoric disorder
• menopause
• chronic disease
• continuous use of medication
• under hormonal therapy
• infection
• using any method to cope with premenstrual syndrome

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kutahya Health Sciences University- Health Sciences Faculty

Kütahya, Kütahya, 43000, Turkey (Türkiye)

Location

Related Publications (3)

• Mohebbi Dehnavi Z, Jafarnejad F, Sadeghi Goghary S. The effect of 8 weeks aerobic exercise on severity of physical symptoms of premenstrual syndrome: a clinical trial study. BMC Womens Health. 2018 May 31;18(1):80. doi: 10.1186/s12905-018-0565-5.

  PMID: 29855308 BACKGROUND

• Heydari N, Abootalebi M, Jamalimoghadam N, Kasraeian M, Emamghoreishi M, Akbarzadeh M. Investigation of the effect of aromatherapy with Citrus aurantium blossom essential oil on premenstrual syndrome in university students: A clinical trial study. Complement Ther Clin Pract. 2018 Aug;32:1-5. doi: 10.1016/j.ctcp.2018.04.006. Epub 2018 Apr 14.

  PMID: 30057033 BACKGROUND

• Ghaffarilaleh G, Ghaffarilaleh V, Sanamno Z, Kamalifard M. Yoga positively affected depression and blood pressure in women with premenstrual syndrome in a randomized controlled clinical trial. Complement Ther Clin Pract. 2019 Feb;34:87-92. doi: 10.1016/j.ctcp.2018.11.007. Epub 2018 Nov 9.

  PMID: 30712751 BACKGROUND

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Manual Lymphatic Drainage; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Drainage; Physical Therapy Modalities; Rehabilitation; Electric Stimulation Therapy; Analgesia; Anesthesia and Analgesia

Study Officials

• Gamze KURT, Ph.D.

  Kutahya Health Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The researcher who made the assessments and participants do not know which group participants belong to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

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

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 22, 2022
• Study Start: April 4, 2022
• Primary Completion: December 31, 2023
• Study Completion: February 15, 2024
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)