NCT06233773 The Effect of Kinesio Taping and Manual Lymph Drainage on Pregnant Women With Restless Legs Syndrome
| NCT ID | NCT06233773 |
| Status | Recruiting |
| Phase | — |
| Sponsor | TC Erciyes University |
| Condition | Pregnancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2025-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2024-04-01 with a primary completion date of 2025-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
MÜRÜVVET BAŞER, Prof. Dr.
PRINCIPAL INVESTIGATOR
Erciyes U
Frequently Asked Questions
Who can join the NCT06233773 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06233773 currently recruiting?
Yes, NCT06233773 is actively recruiting participants. Contact the research team at alikaplan@kayseri.edu.tr for enrollment information.
Where is the NCT06233773 trial being conducted?
This trial is being conducted at Kayseri, Turkey (Türkiye).
Who is sponsoring the NCT06233773 clinical trial?
NCT06233773 is sponsored by TC Erciyes University. The principal investigator is MÜRÜVVET BAŞER, Prof. Dr. at Erciyes U. The trial plans to enroll 80 participants.