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

Not Applicable

Completed

• Conditions: Restless Legs Syndrome; Pregnancy Related; Sleep Disorder
• Interventions: Device: Compression stocks; Other: Knee socks

• Registration Number: NCT05795868
• Lead Sponsor: TC Erciyes University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-25
• Primary Completion: 2022-04-30
• Status Verified: 2023-03
• Study Completion: 2023-03-20
• Study First Submitted: 2023-03-21
• Study First Submitted QC: 2023-03-21
• Last Update Submitted: 2023-03-21
• Study First Posted: 2023-04-03
• Last Update Posted: 2023-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Compression stockings group	Compression stocks	Pregnant women in the compression stockings group will wear the socks given for 3 weeks.
Placebo sock group	Knee socks	Pregnant women in the placebo socks group will wear the socks given for 3 weeks.

Primary Outcome Measures

Name	Time	Method
RLS Severity Rating Scale	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 Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index	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.

Trial Locations

Locations (2)

Erciyes University; 🇹🇷 Kayseri, Turkey

Özlem Kaplan; 🇹🇷 Kayseri, Turkey