UnknownNot Applicable

The Effect of Kinesio Taping and Manual Lymph Drainage on Pregnant Women With Restless Legs Syndrome

Turkey (Türkiye)80 participantsStarted 2024-04-01

Plain-language summary

Restless Leg Syndrome, a progressive and recurrent chronic sensorimotor disorder that creates an irresistible urge to move the legs and a feeling of discomfort, is seen in 15.4-26.0% of pregnant women in our country. Restless Leg Syndrome has negative effects on sleep, mood, cognitive health, daily activities and behavior in pregnant women; It can also cause preeclampsia, difficult labor, and cesarean delivery. Therefore, it is important for pregnant women with Restless Leg Syndrome to be treated appropriately. It is recommended that pregnant women use non-pharmacological treatments as they are not risky for fetal health. Kinesio taping and manual lymphatic drainage methods are used non-pharmacologically to support venous-lymphatic drainage and manage pain. These methods are economical, reliable and easy to apply. However, no study has been found in which Kinesio taping or manual lymphatic drainage was applied to a patient group with Restless Leg Syndrome during or outside pregnancy. The aim of this project is to determine the effect of Kinesio taping and manual lymphatic drainage on Restless Legs Syndrome severity, sleep quality and psychological well-being in pregnant women with Restless Legs Syndrome.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Over 18 years of age, * Literate, * Gestational week 13 and above, * She has a singleton pregnancy, * Presence of RLS according to the RLS Diagnostic Criteria Questionnaire and physician examination, * A score of 11 or above on the RLS Severity Rating Scale, * Pregnant women taking iron, vitamin D, magnesium and calcium will be included in the study. Exclusion Criteria: * Pre-pregnancy RLS, * Communication barriers, * Absolute bed rest for reasons such as cervical insufficiency, premature rupture of membranes or risk of preterm labor, * Have any psychiatric illness, use antipsychotic and/or antidepressant medication, * Acute infection of bacterial or viral origin, * Varicose veins in the feet and legs and severe lymphedema (circumference difference between both extremities over 5 cm), * Have a dermatologic problem in their feet and legs, * Pregnant women with rheumatic diseases such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, systemic lupus erythematosus, fibromyalgia will not be included in the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Restless Leg Syndrome Diagnostic Criteria Survey Form

Timeframe: 13 months

Research Criteria Eligibility Form

Timeframe: 13 months

Personal Information Form

Timeframe: 13 months

Restless Leg Syndrome Severity Rating Scale

Timeframe: 13 months

Richard-Campbell Sleep Scale

Timeframe: 13 months

Psychological Well-Being Scale

Timeframe: 13 months

Application Satisfaction Form

Timeframe: 13 months

Trial details

NCT IDNCT06233773

SponsorTC Erciyes University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04

Contact for this trial

Ali KAPLAN, Dr

05449069417 alikaplan@kayseri.edu.tr

View on ClinicalTrials.gov More Pregnancy trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Restless Leg Syndrome Diagnostic Criteria Survey Form

Timeframe: 13 months

Research Criteria Eligibility Form

Timeframe: 13 months

Personal Information Form

Timeframe: 13 months

Restless Leg Syndrome Severity Rating Scale

Timeframe: 13 months

Richard-Campbell Sleep Scale

Timeframe: 13 months

Psychological Well-Being Scale

Timeframe: 13 months

Application Satisfaction Form

Timeframe: 13 months