An interventional study of Compression stocks and Knee socks in Restless Legs Syndrome, Pregnancy Related and Sleep Disorder, sponsored by TC Erciyes University. Completed at 2 sites in Turkey. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-03.
Sponsored by TC Erciyes University · Not applicable, Interventional, and Supportive care
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.
788 studies on the registry are indexed under Sleep Wake Disorders; 186 are open to participants now.
This study's enrollment of 70 is above the median of 62 across 548 interventional studies indexed under Sleep Wake Disorders.
Browse Sleep Wake Disorders studies →TC Erciyes University is the lead sponsor of 341 studies on the registry; 76 are open to participants now.
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Exclusion Criteria:
Pregnant women in the compression stockings group will wear the socks given for 3 weeks.
Device: Compression stocks
Pregnant women in the placebo socks group will wear the socks given for 3 weeks.
Other: Knee socks
Pregnant women in the compression stockings group will wear the socks given for 3 weeks.
Pregnant women in the Knee socks group will wear the socks given for 3 weeks.
RLS Severity Rating Scale
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.
Time frame: Change from baseline score at the end of 21. days
Pittsburgh Sleep Quality Index
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.
Time frame: Change from baseline score at the end of 21. days
World Health Organization-5 Index of Well-being (WHO-5)
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.
Time frame: Change from baseline score at the end of 21. days
Plan to share: No — Will be shared after the study ends.
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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TC Erciyes University