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

NCT ID: NCT05340816

Last Updated: 2025-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-04

Study Completion Date

2024-02-15

Brief Summary

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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

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Conditions

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Premenstrual Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

DOUBLE

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

Study Groups

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Manual Lymphatic Drainage

5 days, 30 minutes, Manual Lymphatic Drainage

Group Type EXPERIMENTAL

Manual Lymphatic Drainage

Intervention Type 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

5 days, 20 minutes, Transcutaneous Electrical Nerve Stimulation

Group Type EXPERIMENTAL

Transcutaneous Electrical Nerve Stimulation

Intervention Type 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.

Control

no any intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Manual 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.

Intervention Type OTHER

Transcutaneous 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kutahya Health Sciences University

OTHER

Sponsor Role lead

Responsible Party

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Gamze Kurt

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gamze KURT, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Kutahya Health Science University

Locations

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Kutahya Health Sciences University- Health Sciences Faculty

Kütahya, Kütahya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 29855308 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30057033 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30712751 (View on PubMed)

Other Identifiers

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PMS-1

Identifier Type: -

Identifier Source: org_study_id

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