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

Premenstrual Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05340816
• Other study ID #: PMS-1
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 4, 2022
• Est. completion date: October 2023

Study information

• Verified date: March 2023
• Source: Kutahya Health Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 45
• Est. completion date: October 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Premenstrual Syndrome
• Syndrome

Intervention

Other:
• 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.

Device:
• 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.

Locations

Country	Name	City	State
Turkey	Kutahya Health Sciences University- Health Sciences Faculty	Kütahya

Sponsors (1)

Lead Sponsor	Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. Complem — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1 month
Secondary	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.	1 month
Secondary	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.	1 month