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

TC Erciyes University

Status: Unknown

Conditions: Sleep Disorder; Pregnant; Restless Legs Syndrome

Treatments: Other: Cold Water Application; Other: Hot Water Application

Study type: Interventional

Funder types: Other

Identifiers

NCT04786314

TDK-2020-10628

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Least literate
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

1. Those who have a communication disability,
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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Hot Water Application Group

Experimental group

Description:

Pregnant women will apply hot water to their legs before going to sleep for a week, depending on the groups they are in.

Treatment:

Other: Hot Water Application

Cold Water Application Group

Experimental group

Description:

Pregnant women will apply cold water to their legs before going to sleep for a week, depending on the groups they are in.

Treatment:

Other: Cold Water Application

Control Group

No Intervention group

Description:

There will be no intervention other than routine follow-up and maintenance.