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

NCT06233773 | Recruiting

• 1 other identifier: Erciyes U - Ali KAPLAN
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Restless Leg Syndrome; Nursing

Outcome Measures

Primary Outcomes (7)

• Restless Leg Syndrome Diagnostic Criteria Survey Form

  The diagnosis form was created by the International Restless Legs Syndrome Study Group in 1995, based on the patient's history. The form, with a Cronbach alpha coefficient of 0.81, consists of 5 questions. A diagnosis of Restless Leg Syndrome is made by answering "yes" to all questions on the form. The reliability and validity study of the form in Turkey was conducted.

  13 months

• Research Criteria Eligibility Form

  The form created by the researchers will be used to determine whether pregnant women meet the eligibility criteria for the study. The form consists of two parts: inclusion criteria and exclusion criteria. Criteria are answered yes or no. In order for pregnant women to be included in the study, they must answer yes to all inclusion criteria and no to all exclusion criteria.

  13 months

• Personal Information Form

  The form prepared by the researchers consists of questions containing socio-demographic and obstetric characteristics of women and a section containing lower extremity circumference measurement values of pregnant women.

  13 months

• Restless Leg Syndrome Severity Rating Scale

  Scale was developed by the International Restless Legs Syndrome Study Group. The Restless Leg Syndrome Rating Scale, with a Cronbach alpha coefficient of 0.82, consists of 10 questions. Restless Leg Syndrome severity values in each question are graded as having no effect of Restless Leg Syndrome (0 points) or having a very severe effect (4 points). Thus, a total score is obtained, with the entire score range ranging between 0 and 40. The score between 1-10 indicates the presence of mild, the score between 11-20 indicates the presence of moderate, the score between 21-30 indicates the presence of severe, and the score between 31-40 indicates the presence of very severe Restless Leg Syndrome. A validity and reliability study of the scale was conducted in our country.

  13 months

• Richard-Campbell Sleep Scale

  It was developed by Richards in 1987. The Richard-Campbell Sleep Scale consists of 6 items and this scale evaluates the depth of night sleep, the time it takes to fall asleep, the frequency of waking up, the time spent awake when waking up, the quality of sleep and the noise level in the environment. Each item of the scale is evaluated using the visual analog scale technique ranging from 0 to 100. A score of "0-25" from the scale indicates "very poor sleep" and a score of "76-100" indicates "very good sleep". When calculating the total score of the scale, the scores from 5 items are added together, and the 6th item, which evaluates the noise level in the environment, is not included in the total score evaluation. It is thought that as the scale score increases, the patient's sleep quality also increases.

  13 months

• Psychological Well-Being Scale

  The scale was first named "Psychological Well-Being Scale", but its name was later revised to "Flourishing Scale", as it was thought that it would better express psychological well-being. The adaptation of the scale to Turkish was done, and the first name of the scale was used on the grounds that it was not the exact equivalent of the word flourishing. The scale, which consists of 8 items, is one-dimensional and contains positive expressions. The lowest score that can be obtained from the 7-point Likert type scale (between 1: Strongly disagree and 7: Strongly agree) is 8 and the highest score is 56. High scores on the unidimensional scale indicate a high level of psychological well-being. In the reliability study of the scale, the Cronbach's alpha internal consistency was calculated as 0.80 and the test-retest coefficient was calculated as 0.86, and it was stated that the scale is valid and reliable for use.

  13 months

• Application Satisfaction Form

  The form was created by the researchers to determine the participants' satisfaction levels with the application. Satisfaction levels consist of two parts, where positive and negative feedback about the application is expressed numerically on a 10-point scale and open-ended. The form will be filled out by pregnant women at the end of the application along with the final test.

  13 months

Study Arms (4)

Kinesio Taping Group

EXPERIMENTAL

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.

Procedure: Kinesio Taping

Manual Lymph Drainage Group

EXPERIMENTAL

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.

Procedure: Manual Lymph Drainage

Kinesio Taping and Manual Lymph Drainage Group

EXPERIMENTAL

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.

Procedure: Kinesio Taping; Procedure: Manual Lymph Drainage

Control Group

ACTIVE COMPARATOR

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

Other: Control Group

Interventions

Kinesio Taping PROCEDURE

Kinesio Taping

Kinesio Taping Group; Kinesio Taping and Manual Lymph Drainage Group

Manual Lymph Drainage PROCEDURE

Manual Lymph Drainage Group

Kinesio Taping and Manual Lymph Drainage Group; Manual Lymph Drainage Group

Control Group OTHER

Control Group

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University Medical faculty hospital

Kayseri, Talas, 38280, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Manual Lymphatic Drainage; Control Groups

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Drainage; Physical Therapy Modalities; Rehabilitation; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• MÜRÜVVET BAŞER, Prof. Dr.

  Erciyes U

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali KAPLAN, Dr

CONTACT

05449069417; alikaplan@kayseri.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Dr.

Model Details: This research is a randomized controlled experimental study.

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 31, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)