NCT05795868

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: TC Erciyes University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Restless Legs Syndrome
• Pregnancy Related
• Sleep Disorder

Interventions

Type	Name	Description
DEVICE	Compression stocks	Pregnant women in the compression stockings group will wear the socks given for 3 weeks.
OTHER	Knee socks	Pregnant women in the Knee socks group will wear the socks given for 3 weeks.

Timeline

• Start date: 2022-04-25
• Primary completion: 2022-04-30
• Completion: 2023-03-20
• First posted: 2023-04-03
• Last updated: 2023-04-03

Locations

2 sites across 1 country: Turkey (Türkiye)