The Effect of Hot and Cold Water Application on Pregnant Women With Restless Leg Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Hot and Cold Water Application to Pregnant Women With Restless Legs Syndrome on Complaints and Quality of Sleep

Conditions
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Restless Legs Syndrome, Pregnant, Sleep Disorder

Intervention / Treatment
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* Other: Hot Water Application
* Other: Cold Water Application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Least literate 24-32. 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 Exclusion Criteria: 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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hot Water Application Group<br>Pregnant women will apply hot water to their legs before going to sleep for a week, depending on the groups they are in. | Other: Hot Water Application<br>* Pregnant women will apply hot water to their legs before going to sleep for a week.<br>|
| Experimental: Cold Water Application Group<br>Pregnant women will apply cold water to their legs before going to sleep for a week, depending on the groups they are in. | Other: Cold Water Application<br>* Pregnant women will apply cold water to their legs before going to sleep for a week.<br>|
| No Intervention: Control Group<br>There will be no intervention other than routine follow-up and maintenance. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | change from baseline score at the end of one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | change from baseline score at the end of one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Restless legs syndrome, Pregnant, Cold Water Application, Hot Water Application, Quality of Sleep