Skip to main content
OpenTrials
Completed

NCT Number: NCT05795868

The Effect of Compression Stockings on the Complaints of Pregnant Women With Restless Leg Syndrome

The aim of this project is to determine the effect of compression stockings on the complaints, well-being and sleep quality of pregnant women with restless legs syndrome (RLS). The research is a pretest-posttest randomized placebo-controlled experimental study. The study will be carried out with a total of 70 people, 35 in the compression stocking group and 35 in the placebo stocking group. Study data will be collected with RLS Diagnostic Criteria Questionnaire Form, Research Criteria Compliance Form, Personal Information Form, RLS Severity Rating Scale, Pittsburgh Sleep Quality Index (PUKI), WHO-5 and Implementation Satisfaction Form. Pregnant women in both groups will wear the stockings given for three weeks after the first interview.

Data analysis obtained in the research will be performed in TURCOSA statistical software (Turcosa Analytics Ltd Co, Turkey, www.turcosa.com.tr).In comparisons, a value of p <0.05 will be considered statistically significant. In order to conduct the study, the necessary Academic Committee decision, Ethics Committee approval (December 08, 2021 and number 2021/781) and institutional permission were obtained. The individuals included in the study will be informed about the purpose of the research, their verbal consent will be obtained and the participant's informed consent form will be signed.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Restless Legs Syndrome Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Parasomnias Pathological Conditions, Signs and Symptoms Pregnancy Related Signs and Symptoms Sleep Disorder Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University, Kayseri, Turkey (Türkiye)

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Least literate,
  • Between the ages of 18 and 40,
  • At 27 and above gestational week,
  • Single pregnancy,
  • Presence of RLS according to the RLS Diagnostic Criteria Questionnaire Form,
  • Having a severity of 11 and above according to the RLS Severity Rating Scale,
  • Using Iron, Vitamin D, Magnesium and Calcium,
  • Pregnant women with a hemoglobin level of 11 g/dl and above,
  • Pregnant women who can wear socks all day long, except for going to sleep, will be included in the study.

Exclusion criteria

  • Having a communication barrier,
  • Having a risky pregnancy (risk of preterm labor, cervical insufficiency, preeclampsia, polyhydramnios, macrosomic baby, etc.),
  • Having RLS before pregnancy,
  • Having a chronic disease (Diabetes, hypertension, thyroid, cardiovascular disease, etc.),
  • With maternal obesity (BMI>30)
  • Having sleep apnea before pregnancy,
  • Having any psychiatric disease and using antipsychotic and antidepressant drugs,
  • Using heparin, antihistamine, antiemetic, calcium channel blocker, dextromethorphan and decongestant type drugs,
  • Having a dermatological problem in the feet and legs,
  • Pregnant women with varicose veins on their feet and legs will not be included in the study

Treatment and study plan

Compression stocks

Device

Pregnant women in the compression stockings group will wear the socks given for 3 weeks.

Knee socks

Other

Pregnant women in the Knee socks group will wear the socks given for 3 weeks.

Primary outcomes

  1. RLS Severity Rating Scale

    Time frame: Change from baseline score at the end of 21. days

    The RLS Severity Rating Scale was developed in 2003 by the International Restless Legs Syndrome Study Group. The scale was applied in the selection of patients and in the weekly evaluation of RLS severity. The scale comprised ten questions; each question was scored between 0 and 4. Questions 1, 2, 4, 6, 7, and 8 were related to RLS symptoms, questions 5, 9, and 10 were related to the effect of the disease on the mental state and daily social activities of patients with RLS, and question 3 was about the diagnostic criteria of RLS. The overall score indicated the RLS severity. A minimum score of 0 and a maximum score of 40 could be obtained. A score between 1 and 10 corresponded to "mild," 11-20 "moderate," 21-30 "severe," and 31-40 "very severe" RLS.

Secondary outcomes

  1. Pittsburgh Sleep Quality Index

    Time frame: Change from baseline score at the end of 21. days

    The form consists of a total of 24 questions. Each question is scored between 0 and 3. Pittsburgh Sleep Quality Index score in the 0-21 range, with high scores indicating poor sleep quality. If the Pittsburgh Sleep Quality Index global score is greater than 5, it indicates that the sleep quality is significantly worse. The fact that the Pittsburgh Sleep Quality Index score is above 5 indicates that the person has serious trouble in at least two areas related to his sleep, or that he has mild or moderate difficulty in more than three areas.

Other outcomes

  1. World Health Organization-5 Index of Well-being (WHO-5)

    Time frame: Change from baseline score at the end of 21. days

    The WHO-5 questionnaire consists of 5 items containing positive statements about the participant's feelings in the last 2 weeks. Each item is evaluated on a 6-point Likert-type scale between 0-5; 0 points indicates no positive feelings in the last 2 weeks, 5 points indicates continuous positive feelings. The raw score is calculated by adding the numbers from the five answers. The total score that can be obtained from the scale varies between 0 and 25. 0 represents the worst possible quality of life and 25 the best possible quality of life, while a score below 13 indicates poor quality of life.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

The Effect of Compression Stockings on the Complaints, Well-Being and Sleep Quality of Pregnant Women With Restless Legs Syndrome

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Apr 3, 2023
Registry last updated
Apr 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.