The Effect of Hot and Cold Water Application on Pregnant Women With Restless Leg Syndrome (RLS)
Primary Purpose
Restless Legs Syndrome, Pregnant, Sleep Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hot Water Application
Cold Water Application
Sponsored by
About this trial
This is an interventional supportive care trial for Restless Legs Syndrome focused on measuring Restless legs syndrome, Pregnant, Cold Water Application, Hot Water Application, Quality of Sleep
Eligibility Criteria
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.
Sites / Locations
- Erciyes UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Hot Water Application Group
Cold Water Application Group
Control Group
Arm Description
Pregnant women will apply hot water to their legs before going to sleep for a week, depending on the groups they are in.
Pregnant women will apply cold water to their legs before going to sleep for a week, depending on the groups they are in.
There will be no intervention other than routine follow-up and maintenance.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04786314
Brief Title
The Effect of Hot and Cold Water Application on Pregnant Women With Restless Leg Syndrome
Acronym
RLS
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Legs Syndrome, Pregnant, Sleep Disorder
Keywords
Restless legs syndrome, Pregnant, Cold Water Application, Hot Water Application, Quality of Sleep
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hot Water Application Group
Arm Type
Experimental
Arm Description
Pregnant women will apply hot water to their legs before going to sleep for a week, depending on the groups they are in.
Arm Title
Cold Water Application Group
Arm Type
Experimental
Arm Description
Pregnant women will apply cold water to their legs before going to sleep for a week, depending on the groups they are in.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
There will be no intervention other than routine follow-up and maintenance.
Intervention Type
Other
Intervention Name(s)
Hot Water Application
Intervention Description
Pregnant women will apply hot water to their legs before going to sleep for a week.
Intervention Type
Other
Intervention Name(s)
Cold Water Application
Intervention Description
Pregnant women will apply cold water to their legs before going to sleep for a week.
Primary Outcome Measure Information:
Title
RLS Severity Rating Scale
Description
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.
Time Frame
change from baseline score at the end of one week
Secondary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index
Description
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.
Time Frame
change from baseline score at the end of one week
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Since the study will be conducted with pregnant women with restless legs syndrome, only women were included in the study.
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Erciyes University
City
Melikgazi
State/Province
Kayseri
ZIP/Postal Code
38260
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Özlem Kaplan
Phone
05443239550
Email
ozlemkpln-92@outlook.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Will be shared after the study ends.
Learn more about this trial
The Effect of Hot and Cold Water Application on Pregnant Women With Restless Leg Syndrome
We'll reach out to this number within 24 hrs