Clinical trial NCT05795868: The Effect of Compression Stockings on the Complaints of Pregnant Women With Restless Leg Syndrome
Official title: The Effect of Compression Stockings on the Complaints, Well-Being and Sleep Quality of Pregnant Women With Restless Legs Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Restless Legs Syndrome
Pregnancy Related
Sleep Disorder
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2023-04-03
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: RLS Severity Rating Scale
timeFrame: Change from baseline score at the end of 21. days
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: Change from baseline score at the end of 21. days
Other outcomes:
measure: World Health Organization-5 Index of Well-being (WHO-5)
timeFrame: Change from baseline score at the end of 21. days
Locations:
city: Kayseri
country: Turkey
facility: Özlem Kaplan
city: Kayseri
country: Turkey
facility: Erciyes University
Study officials:
References: