Restless Legs SyndromeNCT05795868
The Effect of Compression Stockings on the Complaints of Pregnant Women With Restless Leg Syndrome
A study testing Compression stocks and Knee socks in people with Restless Legs Syndrome and Pregnancy Related, run by TC Erciyes University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Restless Legs Syndrome, Pregnancy Related, Sleep Disorder
- What is being tested?
- Compression stocks and Knee socks
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 25 Apr 2022to 20 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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,
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- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Özlem Kaplan
Kayseri, 38280
Erciyes University
Kayseri
About this study
Official title: The Effect of Compression Stockings on the Complaints, Well-Being and Sleep Quality of Pregnant Women With Restless Legs Syndrome
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.
- Conditions
- Restless Legs Syndrome, Pregnancy Related, Sleep Disorder
- Being tested
- Compression stocks, Knee socks
- Medical subject headings
- Restless Legs Syndrome, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression stocksDevice
Pregnant women in the compression stockings group will wear the socks given for 3 weeks.
Knee socksOther
Pregnant women in the Knee socks group will wear the socks given for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Compression stockings group | Experimental | Pregnant women in the compression stockings group will wear the socks given for 3 weeks. Receives: Device: Compression stocks |
| Placebo sock group | Placebo comparator | Pregnant women in the placebo socks group will wear the socks given for 3 weeks. Receives: Other: Knee socks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline score at the end of 21. days
Secondary outcomes (1)
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.
Measured: Change from baseline score at the end of 21. days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start25 Apr 2022
- Primary completion30 Apr 2022
- Study completion20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Ozlem Kaplan, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795868
- Sponsor's protocol ID
- 221S452
- Status last verified
- Mar 2023
- First submitted
- 21 Mar 2023
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will be shared after the study ends.
Publications
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.
PubMed 39166663
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Compression Stockings on the Complaints, Well-Being and Sleep Quality of Pregnant Women With Restless Legs Syndrome
- ClinicalTrials.gov ID
- NCT05795868
- Acronym / sponsor ID
- 221S452
- Conditions
- Restless Legs Syndrome, Pregnancy Related, Sleep Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compression stockings group | Experimental | Device: Compression stocksPregnant women in the compression stockings group will wear the socks given for 3 weeks. |
| Placebo sock group | Placebo comparator | Other: Knee socksPregnant women in the placebo socks group will wear the socks given for 3 weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compression stocksPregnant women in the compression stockings group will wear the socks given for 3 weeks. | Device | Compression stockings group |
| Knee socksPregnant women in the Knee socks group will wear the socks given for 3 weeks. | Other | Placebo sock group |
Primary outcome
RLS Severity Rating Scale
Time frame: Change from baseline score at the end of 21. days
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.
1 secondary outcome
Pittsburgh Sleep Quality Index
Time frame: Change from baseline score at the end of 21. days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Derived from this study: PubMed 39166663Kaplan 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.
- Individual participant dataSharing planned: No. Will be shared after the study ends.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression stocks and Knee socks in people with Restless Legs Syndrome and Pregnancy Related, run by TC Erciyes University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RLS Severity Rating Scale (time frame: Change from baseline score at the end of 21. days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05795868, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.