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

Sponsor

TC Erciyes University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04786314

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Restless Legs Syndrome Pregnant Sleep Disorder	Other: Hot Water Application Other: Cold Water Application	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Sep 30, 2020

Anticipated Primary Completion Date :

Sep 30, 2021

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: Hot Water Application Pregnant women will apply hot water to their legs before going to sleep for a week.
Experimental: 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.	Other: Cold Water Application Pregnant women will apply cold water to their legs before going to sleep for a week.
No Intervention: Control Group There will be no intervention other than routine follow-up and maintenance.

Arm

Intervention/Treatment

Experimental: 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.

Other: Hot Water Application

Pregnant women will apply hot water to their legs before going to sleep for a week.

Experimental: 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.

Other: Cold Water Application

Pregnant women will apply cold water to their legs before going to sleep for a week.

No Intervention: Control Group

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

Outcome Measures

Primary Outcome Measures

RLS Severity Rating Scale [change from baseline score at the end of one week]
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.

Secondary Outcome Measures

Pittsburgh Sleep Quality Index [change from baseline score at the end of one week]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.