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

Sleep Disorder Clinical Trial

— RLS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04786314
• Other study ID #: TDK-2020-10628
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: March 2021
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Pregnant
• Psychomotor Agitation
• Restless Legs Syndrome
• Sleep Disorder
• Sleep Wake Disorders
• Syndrome

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Erciyes University	Melikgazi	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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