search
Back to results

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

Primary Purpose

Premenstrual Syndrome

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Manual Lymphatic Drainage
Transcutaneous Electrical Nerve Stimulation
Sponsored by
Kutahya Health Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premenstrual Syndrome focused on measuring Manual Lymphatic Drainage, Transcutaneous Electrical Nerve Stimulation, Premenstrual Syndrome, Quality of Life, Autonomic Functions

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kutahya Health Sciences University- Health Sciences Faculty

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Manual Lymphatic Drainage

Transcutaneous Electrical Nerve Stimulation

Control

Arm Description

5 days, 30 minutes, Manual Lymphatic Drainage

5 days, 20 minutes, Transcutaneous Electrical Nerve Stimulation

no any intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 6, 2022
Last Updated
March 2, 2023
Sponsor
Kutahya Health Sciences University
search

1. Study Identification

Unique Protocol Identification Number
NCT05340816
Brief Title
The Effects of Manual Lymphatic Drainage and Transcutaneous Electrical Nerve Stimulation in Premenstrual Syndrome
Official Title
The Effect of Manual Lymphatic Drainage and Transcutaneous Electrical Nerve Stimulation Methods in Women With Premenstrual Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 4, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kutahya Health Sciences University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome
Keywords
Manual Lymphatic Drainage, Transcutaneous Electrical Nerve Stimulation, Premenstrual Syndrome, Quality of Life, Autonomic Functions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned to manual lymph drainage, transcutaneous electrical nerve stimulation, or a control group.
Masking
ParticipantOutcomes Assessor
Masking Description
The researcher who made the assessments and participants do not know which group participants belong to.
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Manual Lymphatic Drainage
Arm Type
Experimental
Arm Description
5 days, 30 minutes, Manual Lymphatic Drainage
Arm Title
Transcutaneous Electrical Nerve Stimulation
Arm Type
Experimental
Arm Description
5 days, 20 minutes, Transcutaneous Electrical Nerve Stimulation
Arm Title
Control
Arm Type
No Intervention
Arm Description
no any intervention
Intervention Type
Other
Intervention Name(s)
Manual Lymphatic Drainage
Intervention Description
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
Device
Intervention Name(s)
Transcutaneous Electrical Nerve Stimulation
Intervention Description
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 Outcome Measure Information:
Title
The Premenstrual Syndrome Scale (PMSS)
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Heart rate and Heart rate variability
Description
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.
Time Frame
1 month
Title
Visual analog scale (VAS) for pain levels
Description
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.
Time Frame
1 month
Title
Short form of the World Health Organization Quality of Life Questionnaire (WHOQOL)
Description
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.
Time Frame
1 month

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gamze KURT, Ph.D.
Organizational Affiliation
Kutahya Health Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kutahya Health Sciences University- Health Sciences Faculty
City
Kütahya
ZIP/Postal Code
43000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29855308
Citation
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.
Results Reference
result
PubMed Identifier
30057033
Citation
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.
Results Reference
result
PubMed Identifier
30712751
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs