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The Effect of Compression Stockings on the Complaints of Pregnant Women With Restless Leg Syndrome

Primary Purpose

Restless Legs Syndrome, Pregnancy Related, Sleep Disorder

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Compression stocks
Knee socks
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Restless Legs Syndrome

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Least literate, Between the ages of 18 and 40, At 27 and above gestational week, Single pregnancy, Presence of RLS according to the RLS Diagnostic Criteria Questionnaire Form, Having a severity of 11 and above according to the RLS Severity Rating Scale, Using Iron, Vitamin D, Magnesium and Calcium, Pregnant women with a hemoglobin level of 11 g/dl and above, Pregnant women who can wear socks all day long, except for going to sleep, will be included in the study. Exclusion Criteria: Having a communication barrier, Having a risky pregnancy (risk of preterm labor, cervical insufficiency, preeclampsia, polyhydramnios, macrosomic baby, etc.), Having RLS before pregnancy, Having a chronic disease (Diabetes, hypertension, thyroid, cardiovascular disease, etc.), With maternal obesity (BMI>30) Having sleep apnea before pregnancy, Having any psychiatric disease and using antipsychotic and antidepressant drugs, Using heparin, antihistamine, antiemetic, calcium channel blocker, dextromethorphan and decongestant type drugs, Having a dermatological problem in the feet and legs, Pregnant women with varicose veins on their feet and legs will not be included in the study

Sites / Locations

  • Özlem Kaplan
  • Erciyes University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Compression stockings group

Placebo sock group

Arm Description

Pregnant women in the compression stockings group will wear the socks given for 3 weeks.

Pregnant women in the placebo socks group will wear the socks given for 3 weeks.

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

First Posted
March 21, 2023
Last Updated
March 21, 2023
Sponsor
TC Erciyes University
Collaborators
The Scientific and Technological Research Council of Turkey
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1. Study Identification

Unique Protocol Identification Number
NCT05795868
Brief Title
The Effect of Compression Stockings on the Complaints of Pregnant Women With Restless Leg Syndrome
Official Title
The Effect of Compression Stockings on the Complaints, Well-Being and Sleep Quality of Pregnant Women With Restless Legs Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 25, 2022 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
March 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University
Collaborators
The Scientific and Technological Research Council of Turkey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this project is to determine the effect of compression stockings on the complaints, well-being and sleep quality of pregnant women with restless legs syndrome (RLS). The research is a pretest-posttest randomized placebo-controlled experimental study. The study will be carried out with a total of 70 people, 35 in the compression stocking group and 35 in the placebo stocking group. Study data will be collected with RLS Diagnostic Criteria Questionnaire Form, Research Criteria Compliance Form, Personal Information Form, RLS Severity Rating Scale, Pittsburgh Sleep Quality Index (PUKI), WHO-5 and Implementation Satisfaction Form. Pregnant women in both groups will wear the stockings given for three weeks after the first interview. 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 (December 08, 2021 and number 2021/781) 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, Pregnancy Related, Sleep Disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Compression stockings group
Arm Type
Experimental
Arm Description
Pregnant women in the compression stockings group will wear the socks given for 3 weeks.
Arm Title
Placebo sock group
Arm Type
Placebo Comparator
Arm Description
Pregnant women in the placebo socks group will wear the socks given for 3 weeks.
Intervention Type
Device
Intervention Name(s)
Compression stocks
Intervention Description
Pregnant women in the compression stockings group will wear the socks given for 3 weeks.
Intervention Type
Other
Intervention Name(s)
Knee socks
Intervention Description
Pregnant women in the Knee socks group will wear the socks given for 3 weeks.
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 21. days
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 21. days
Other Pre-specified Outcome Measures:
Title
World Health Organization-5 Index of Well-being (WHO-5)
Description
The WHO-5 questionnaire consists of 5 items containing positive statements about the participant's feelings in the last 2 weeks. Each item is evaluated on a 6-point Likert-type scale between 0-5; 0 points indicates no positive feelings in the last 2 weeks, 5 points indicates continuous positive feelings. The raw score is calculated by adding the numbers from the five answers. The total score that can be obtained from the scale varies between 0 and 25. 0 represents the worst possible quality of life and 25 the best possible quality of life, while a score below 13 indicates poor quality of life.
Time Frame
Change from baseline score at the end of 21. days

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.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Least literate, Between the ages of 18 and 40, At 27 and above gestational week, Single pregnancy, Presence of RLS according to the RLS Diagnostic Criteria Questionnaire Form, Having a severity of 11 and above according to the RLS Severity Rating Scale, Using Iron, Vitamin D, Magnesium and Calcium, Pregnant women with a hemoglobin level of 11 g/dl and above, Pregnant women who can wear socks all day long, except for going to sleep, will be included in the study. Exclusion Criteria: Having a communication barrier, Having a risky pregnancy (risk of preterm labor, cervical insufficiency, preeclampsia, polyhydramnios, macrosomic baby, etc.), Having RLS before pregnancy, Having a chronic disease (Diabetes, hypertension, thyroid, cardiovascular disease, etc.), With maternal obesity (BMI>30) Having sleep apnea before pregnancy, Having any psychiatric disease and using antipsychotic and antidepressant drugs, Using heparin, antihistamine, antiemetic, calcium channel blocker, dextromethorphan and decongestant type drugs, Having a dermatological problem in the feet and legs, Pregnant women with varicose veins on their feet and legs will not be included in the study
Facility Information:
Facility Name
Özlem Kaplan
City
Kayseri
ZIP/Postal Code
38280
Country
Turkey
Facility Name
Erciyes University
City
Kayseri
Country
Turkey

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 Compression Stockings on the Complaints of Pregnant Women With Restless Leg Syndrome

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