Restless Legs SyndromeRLSNCT04786314
The Effect of Hot and Cold Water Application on Pregnant Women With Restless Leg Syndrome
A study testing Hot Water Application and Cold Water Application in people with Restless Legs Syndrome and Pregnant, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Restless Legs Syndrome, Pregnant, Sleep Disorder
- What is being tested?
- Hot Water Application and Cold Water Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2020to 30 Sep 2022
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erciyes University
Melikgazi, Kayseri, 38260
Özlem Kaplan, 05443239550, ozlemkpln-92@outlook.com
About this study
Official title: The Effect of Hot and Cold Water Application to Pregnant Women With Restless Legs Syndrome on Complaints and Quality of Sleep
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.
- Conditions
- Restless Legs Syndrome, Pregnant, Sleep Disorder
- Being tested
- Hot Water Application, Cold Water Application
- Keywords
- Restless legs syndrome, Pregnant, Cold Water Application, Hot Water Application, Quality of Sleep
- Medical subject headings
- Restless Legs Syndrome, Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hot Water ApplicationOther
Pregnant women will apply hot water to their legs before going to sleep for a week.
Cold Water ApplicationOther
Pregnant women will apply cold water to their legs before going to sleep for a week.
| Study group | Role | What they receive |
|---|---|---|
| Hot Water Application Group | Experimental | Pregnant women will apply hot water to their legs before going to sleep for a week, depending on the groups they are in. Receives: Other: Hot Water Application |
| Cold Water Application Group | Experimental | Pregnant women will apply cold water to their legs before going to sleep for a week, depending on the groups they are in. Receives: Other: Cold Water Application |
| Control Group | No intervention | There will be no intervention other than routine follow-up and maintenance. |
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 one week
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 one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start30 Sep 2020
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Kaplan, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786314
- Sponsor's protocol ID
- TDK-2020-10628
- Acronym
- RLS
- Status last verified
- Mar 2021
- First submitted
- 1 Mar 2021
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will be shared after the study ends.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hot and Cold Water Application to Pregnant Women With Restless Legs Syndrome on Complaints and Quality of Sleep
- ClinicalTrials.gov ID
- NCT04786314
- Acronym / sponsor ID
- RLS / TDK-2020-10628
- Conditions
- Restless Legs Syndrome, Pregnant, Sleep Disorder
- Keywords
- Restless legs syndrome, Pregnant, Cold Water Application, Hot Water Application, Quality of Sleep
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 8 Mar 2021 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hot Water Application Group | Experimental | Other: Hot Water ApplicationPregnant women will apply hot water to their legs before going to sleep for a week, depending on the groups they are in. |
| Cold Water Application Group | Experimental | Other: Cold Water ApplicationPregnant women will apply cold water to their legs before going to sleep for a week, depending on the groups they are in. |
| Control Group | No intervention | –There will be no intervention other than routine follow-up and maintenance. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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,
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 |
|---|---|---|
| Hot Water ApplicationPregnant women will apply hot water to their legs before going to sleep for a week. | Other | Hot Water Application Group |
| Cold Water ApplicationPregnant women will apply cold water to their legs before going to sleep for a week. | Other | Cold Water Application Group |
Primary outcome
RLS Severity Rating Scale
Time frame: 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.
1 secondary outcome
Pittsburgh Sleep Quality Index
Time frame: change from baseline score at the end of one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hot Water Application and Cold Water Application in people with Restless Legs Syndrome and Pregnant, run by TC Erciyes University at 1 site 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 7 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: status not confirmed, as of the sponsor's last update on 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. 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 one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2021.