Clinical trial NCT05340816: 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
Overall status: COMPLETED
Phase: NA
Conditions: Premenstrual Syndrome
Keywords: Manual Lymphatic Drainage
Transcutaneous Electrical Nerve Stimulation
Premenstrual Syndrome
Quality of Life
Autonomic Functions
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to manual lymph drainage, transcutaneous electrical nerve stimulation, or a control group.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The Premenstrual Syndrome Scale (PMSS)
timeFrame: 1 month
Secondary outcomes:
measure: Heart rate and Heart rate variability
timeFrame: 1 month
measure: Visual analog scale (VAS) for pain levels
timeFrame: 1 month
measure: Short form of the World Health Organization Quality of Life Questionnaire (WHOQOL)
timeFrame: 1 month
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Kutahya Health Sciences University- Health Sciences Faculty
Study officials:
affiliation: Kutahya Health Science University
name: Gamze KURT, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.