The Effect of Hot and Cold Water Application to Pregnant Women With Restless Legs Syndrome on Complaints and Quality of Sleep
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- RLS Severity Rating Scale
研究概览
简要总结
This study was planned as a randomized controlled study to determine the effect of hot and cold water application on complaints and sleep quality in pregnant women with restless legs syndrome (RLS). Pregnant women with a total of 90 RLS, including 30 people in each group, will be included in the study. The data of this study will be collected by Personal Information Form, RLS Diagnosis Criteria Questionnaire, RLS Severity Rating Scale, Pittsburgh Sleep Quality Index, Post Application Follow-up Chart and Application Satisfaction Form.
While hot and cold water is applied in the intervention groups in the study, no application other than routine maintenance and follow-up will be done to the control group.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 (September 09, 2020 and number 2020/445) 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
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Least literate
- •between the weeks of gestation
- •Having a single pregnancy
- •The presence of RLS is detected according to the RLS Diagnostic Criteria Questionnaire
- •Having RLS due to pregnancy
- •Uses Iron, Vitamin D, Magnesium and Calcium
- •Pregnant women who have a severity of 11 or more according to the RLS Severity Rating Scale will be included in the study
排除标准
- •Those who have a communication disability,
- •Risky pregnancy (Preterm labor risk, Cervical insufficiency, etc.),
- •Chronic disease (Diabetes, Hypertension, Thyroid, Cardiovascular disease, epilepsy, etc.),
- •With maternal obesity, BMI> 30
- •He has heirs in his legs,
- •Pre-pregnancy sleep apnea,
- •Having any psychiatric disease and using antipsychotic, antidepressant medication,
- •Using antihistamine, antiepileptic, antiemetic, calcium channel blocker, dextromethorphan and decongestant type drugs,
- •Using heparin,
- •Pregnant women with a history of deep vein thrombosis, or atherosclerosis history or risk will not be included in the study.
研究组 & 干预措施
Hot Water Application Group
Pregnant women will apply hot water to their legs before going to sleep for a week, depending on the groups they are in.
干预措施: Hot Water Application (Other)
Cold Water Application Group
Pregnant women will apply cold water to their legs before going to sleep for a week, depending on the groups they are in.
干预措施: Cold Water Application (Other)
Control Group
There will be no intervention other than routine follow-up and maintenance.
结局指标
主要结局
RLS Severity Rating Scale
时间窗: change from baseline score at the end of one week
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 one week)
研究者
Ozlem Kaplan
Reserch Asistant
TC Erciyes University