The Effect of Hot and Cold Water Application on Pregnant Women With Restless Leg Syndrome
NCT ID: NCT04786314
Last Updated: 2021-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2020-09-30
2022-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Hot Water Application
Pregnant women will apply hot water to their legs before going to sleep for a week.
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.
Cold Water Application
Pregnant women will apply cold water to their legs before going to sleep for a week.
Control Group
There will be no intervention other than routine follow-up and maintenance.
No interventions assigned to this group
Interventions
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Hot Water Application
Pregnant women will apply hot water to their legs before going to sleep for a week.
Cold Water Application
Pregnant women will apply cold water to their legs before going to sleep for a week.
Eligibility Criteria
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Inclusion Criteria
2. 24-32. between the weeks of gestation
3. Having a single pregnancy
4. The presence of RLS is detected according to the RLS Diagnostic Criteria Questionnaire
5. Having RLS due to pregnancy
6. Uses Iron, Vitamin D, Magnesium and Calcium
7. 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
2. Risky pregnancy (Preterm labor risk, Cervical insufficiency, etc.),
3. Chronic disease (Diabetes, Hypertension, Thyroid, Cardiovascular disease, epilepsy, etc.),
4. With maternal obesity, BMI\> 30
5. He has heirs in his legs,
6. Pre-pregnancy sleep apnea,
7. Having any psychiatric disease and using antipsychotic, antidepressant medication,
8. Using antihistamine, antiepileptic, antiemetic, calcium channel blocker, dextromethorphan and decongestant type drugs,
9. Using heparin,
10. Pregnant women with a history of deep vein thrombosis, or atherosclerosis history or risk will not be included in the study.
FEMALE
Yes
Sponsors
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TC Erciyes University
OTHER
Responsible Party
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Ozlem Kaplan
Reserch Asistant
Locations
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Erciyes University
Melikgazi, Kayseri, Turkey (Türkiye)
Countries
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Facility Contacts
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Other Identifiers
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TDK-2020-10628
Identifier Type: -
Identifier Source: org_study_id
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