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

NCT ID: NCT06233773

Last Updated: 2024-05-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-04-30

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.

Conditions

Pregnancy; Restless Leg Syndrome; Nursing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Kinesio Taping Group

In this project, Kinesio Taping will be applied to the Kinesio Taping group to reduce pain and support circulation. In this study, space correction method to reduce pain and lymphatic correction technique to support circulation will be applied from Kinesio Taping methods. In the study, in order to determine the susceptibility to allergy to kinesio tape, a five cm application will be made on the outer lateral region of the arms of pregnant women and waited for 10 minutes. Before the application, the physiotherapist will clean the application area with volatile alcohol for correct and good adhesion of the tape. Four bands of 10 cm each will be cut for the application. In order to protect the tape during the movement of the person, all corners will be oval shaped and the kinesio tape will be adhered to the BL-40 and BL-57 points bilaterally using 25-50% tension with the space correction method.

Group Type: EXPERIMENTAL

Kinesio Taping

Intervention Type: PROCEDURE

Kinesio Taping

Manual Lymph Drainage Group

Before the application, the pregnant woman will open both lower extremities, including the knee area, in a semi-sitting position. The other body parts will be covered with a sheet/sweater so that the leg area is open. Without applying anything (oil, vaseline, cream) to the leg, the physiotherapist will perform Manual Lymph Drainage using his/her hands. The pregnant woman will be asked to do 10 repetitions of diaphragmatic breathing exercise. Popliteal lymph nodes will be stimulated manually 7 times. The anterior and medial knee will be stimulated 7 times each with circular movements. Manual Lymph Drainage will be performed on the front of the leg with the pumping technique and on the back of the leg with the scooping movement. The procedure will be repeated 3 times to provide drainage in the same area. The ankle will be stimulated 7 times with circular movements. The inferior and posterior parts of both the medial malleolus and lateral malleolus will be stimulated.

Group Type: EXPERIMENTAL

Manual Lymph Drainage

Intervention Type: PROCEDURE

Manual Lymph Drainage Group

Kinesio Taping and Manual Lymph Drainage Group

In this group, Kinesio Taping and Manual Lymph Drainage will be performed together to support circulation and reduce pain. All of the procedures performed in the Kinesio Taping Group and the Manual Lymph Drainage Group will be performed in parallel. After Kinesio Taping, Manual Lymph Drainage will be performed for 6 days. The kinesio tape will be renewed on the fourth day and will remain for three more days.

Group Type: EXPERIMENTAL

Kinesio Taping

Intervention Type: PROCEDURE

Kinesio Taping

Manual Lymph Drainage

Intervention Type: PROCEDURE

Manual Lymph Drainage Group

Control Group

Pregnant women in the control group will not be subjected to any intervention other than routine follow-up and care at the hospital.

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: OTHER

Control Group

Interventions

Kinesio Taping

Kinesio Taping

Intervention Type: PROCEDURE

Manual Lymph Drainage

Manual Lymph Drainage Group

Intervention Type: PROCEDURE

Control Group

Control Group

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

TC Erciyes University

OTHER

Sponsor Role: lead

Responsible Party

Ali Kaplan

Assist. Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MÜRÜVVET BAŞER, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Erciyes U

Locations

Erciyes University Medical faculty hospital

Kayseri, Talas, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Ali KAPLAN, Dr

Role: CONTACT

alikaplan@kayseri.edu.tr

05449069417

Facility Contacts

İptisam İpek Müderris, Prof. Dr.

Role: primary

Other Identifiers

Erciyes U - Ali KAPLAN

Identifier Type: -

Identifier Source: org_study_id