NCT05795868

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2022

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 21, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

5 days

First QC Date

March 21, 2023

Last Update Submit

March 21, 2023

Conditions

Restless Legs SyndromePregnancy RelatedSleep Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 21. days

Secondary Outcomes (1)

  • Pittsburgh Sleep Quality Index

    Change from baseline score at the end of 21. days

Other Outcomes (1)

  • World Health Organization-5 Index of Well-being (WHO-5)

    Change from baseline score at the end of 21. days

Study Arms (2)

Compression stockings group

EXPERIMENTAL

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

Device: Compression stocks

Placebo sock group

PLACEBO COMPARATOR

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

Other: Knee socks

Interventions

Compression stocksDEVICE

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

Compression stockings group
Knee socksOTHER

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

Placebo sock group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSince the study will be conducted with pregnant women with restless legs syndrome, only women were included in the study.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Özlem Kaplan

Kayseri, 38280, Turkey (Türkiye)

Location

Erciyes University

Kayseri, Turkey (Türkiye)

Location

Related Publications (1)

  • Kaplan O, Baser M, Ozgun MT. The effect of compression stockings on the complaints well-being and sleep quality of pregnant women with restless legs syndrome: a randomized controlled study. Rev Assoc Med Bras (1992). 2024 Aug 16;70(7):e20240145. doi: 10.1590/1806-9282.20240145. eCollection 2024.

    PMID: 39166663DERIVED

MeSH Terms

Conditions

Restless Legs SyndromeSleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System DiseasesSleep Disorders, IntrinsicDyssomniasParasomniasMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reserch Asistant

Study Record Dates

First Submitted

March 21, 2023

First Posted

April 3, 2023

Study Start

April 25, 2022

Primary Completion

April 30, 2022

Study Completion

March 20, 2023

Last Updated

April 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Will be shared after the study ends.

Locations

TU(2)