Clinical trial NCT04786314: The Effect of Hot and Cold Water Application on Pregnant Women With Restless Leg Syndrome
Official title: The Effect of Hot and Cold Water Application to Pregnant Women With Restless Legs Syndrome on Complaints and Quality of Sleep
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Restless Legs Syndrome
Pregnant
Sleep Disorder
Keywords: Restless legs syndrome
Pregnant
Cold Water Application
Hot Water Application
Quality of Sleep
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 90
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: RLS Severity Rating Scale
timeFrame: change from baseline score at the end of one week
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: change from baseline score at the end of one week
Other outcomes:
Locations:
city: Melikgazi
country: Turkey
facility: Erciyes University
state: Kayseri
Study officials:
References: