Clinical trial NCT06233773: The Effect of Kinesio Taping and Manual Lymph Drainage on Pregnant Women With Restless Legs Syndrome
Official title: The Effect of Kinesio Taping and Manual Lymph Drainage on Syndrome Severity, Sleep Quality and Psychological Well-Being in Pregnant Women With Restless Leg Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy
Restless Leg Syndrome
Nursing
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This research is a randomized controlled experimental study.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Restless Leg Syndrome, which creates an irresistible urge to move the legs, 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.

It is recommended that pregnant women use non-pharmacological treatments as they are not risky for fetal health. Studies have determined that progressive relaxation exercise and application of hot and cold water to the legs can reduce the severity of symptoms in pregnant women with Restless Leg Syndrome. However, the fact that progressive relaxation exercise covers a long period of time, such as eight weeks, may negatively affect the continuity of the practice in pregnant women. Due to the enlargement of the abdomen in the following weeks of pregnancy, pregnant women have difficulty in putting on and taking off compression stockings and sweat in the summer months; some pregnant women may experience negative effects when applying hot and cold water, such as heat sensitivity or the difficulty of repeating the application every evening. For this reason, it is necessary to increase the variety of non-pharmacological methods that can be recommended by healthcare personnel and by which pregnant women can choose the method most suitable for them in the symptom management of Restless Leg Syndrome that develops due to pregnancy. 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 the patient group with Restless Leg Syndrome during pregnancy or outside of pregnancy. Therefore, experimental studies evaluating the effectiveness of Kinesio taping and manual lymphatic drainage on Restless Leg Syndrome complaints are needed. This study will determine the effectiveness of Kinesio taping and manual lymphatic drainage in Restless Leg Syndrome complaints and provide evidence for the hypothesis that Restless Leg Syndrome may be associated with venous insufficiency. At the end of this project, if it is proven that Kinesio taping has an effect on complaints; a practical and ready-made Kinesio taping product development project that the pregnant woman can use on her own will be planned.

The aim of this project is to determine the effect of Kinesio taping and manual lymphatic drainage on Restless Leg Syndrome severity, sleep quality and psychological well-being in pregnant women with Restless Leg Syndrome. The study will be carried out at Erciyes University Hospital. Pregnant women who meet the inclusion criteria will be randomized into groups (Kinesio taping, manual lymphatic drainage, Kinesio taping + manual lymphatic drainage, Control), with 20 people in each group.

Data will be collected with Restless Leg Syndrome Diagnostic Criteria Survey Form, Research Criteria Compliance Form, Personal Information Form, Restless Leg Syndrome Severity Rating Scale, Richard-Campbell Sleep Scale, Psychological Well-Being Scale and Application Satisfaction Form.

After preliminary tests are performed, kinesio tape will be applied to Kinesio taping group's legs. Manual lymphatic drainage will be built for manual lymphatic drainage Group. Tape will be attached to Kinesio taping+manual lymphatic drainage group and manual lymphatic drainage will be made. No treatment will be applied to the control group. Tests will be repeated on the fourth and seventh days. SPSS program will be used to analyze the data.

Work packages of the study and by whom it will be carried out have been determined. Precautions and plans have been made for the risks that may develop in the project.

The experiences and knowledge gained at the end of the project will be shared by publishing articles or papers in international journals. In addition, it is expected that the scholars will increase their competencies in the field, develop a commercial product after the study, and create new studies or projects. Most importantly, a new method can be offered to pregnant women.

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.

Primary outcomes:
measure: Restless Leg Syndrome Diagnostic Criteria Survey Form
timeFrame: 13 months
measure: Research Criteria Eligibility Form
timeFrame: 13 months
measure: Personal Information Form
timeFrame: 13 months
measure: Restless Leg Syndrome Severity Rating Scale
timeFrame: 13 months
measure: Richard-Campbell Sleep Scale
timeFrame: 13 months
measure: Psychological Well-Being Scale
timeFrame: 13 months
measure: Application Satisfaction Form
timeFrame: 13 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University Medical faculty hospital
state: Talas
Study officials:
affiliation: Erciyes U
name: MÜRÜVVET BAŞER, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: