The Effect of Compression Stockings on the Complaints, Well-Being and Sleep Quality of Pregnant Women With Restless Legs Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- RLS Severity Rating Scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
RLS Severity Rating Scale
时间窗: 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.
次要结局
- Pittsburgh Sleep Quality Index(Change from baseline score at the end of 21. days)
研究者
Ozlem Kaplan
Reserch Asistant
TC Erciyes University