Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-29 @ 11:59 PM
Study NCT ID:
NCT05795868
Status:
COMPLETED
Last Update Posted:
2023-04-03
First Post:
2023-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Compression Stockings on the Complaints of Pregnant Women With Restless Leg Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012148', 'term': 'Restless Legs Syndrome'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-21', 'studyFirstSubmitDate': '2023-03-21', 'studyFirstSubmitQcDate': '2023-03-21', 'lastUpdatePostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'World Health Organization-5 Index of Well-being (WHO-5)', 'timeFrame': 'Change from baseline score at the end of 21. days', '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."}], 'primaryOutcomes': [{'measure': 'RLS Severity Rating Scale', 'timeFrame': 'Change from baseline score at the end of 21. days', '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.'}], 'secondaryOutcomes': [{'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': 'Change from baseline score at the end of 21. days', '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Restless Legs Syndrome', 'Pregnancy Related', 'Sleep Disorder']}, 'referencesModule': {'references': [{'pmid': '39166663', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nData 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Since the study will be conducted with pregnant women with restless legs syndrome, only women were included in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Least literate,\n2. Between the ages of 18 and 40,\n3. At 27 and above gestational week,\n4. Single pregnancy,\n5. Presence of RLS according to the RLS Diagnostic Criteria Questionnaire Form,\n6. Having a severity of 11 and above according to the RLS Severity Rating Scale,\n7. Using Iron, Vitamin D, Magnesium and Calcium,\n8. Pregnant women with a hemoglobin level of 11 g/dl and above,\n9. Pregnant women who can wear socks all day long, except for going to sleep, will be included in the study.\n\nExclusion Criteria:\n\n1. Having a communication barrier,\n2. Having a risky pregnancy (risk of preterm labor, cervical insufficiency, preeclampsia, polyhydramnios, macrosomic baby, etc.),\n3. Having RLS before pregnancy,\n4. Having a chronic disease (Diabetes, hypertension, thyroid, cardiovascular disease, etc.),\n5. With maternal obesity (BMI\\>30)\n6. Having sleep apnea before pregnancy,\n7. Having any psychiatric disease and using antipsychotic and antidepressant drugs,\n8. Using heparin, antihistamine, antiemetic, calcium channel blocker, dextromethorphan and decongestant type drugs,\n9. Having a dermatological problem in the feet and legs,\n10. Pregnant women with varicose veins on their feet and legs will not be included in the study'}, 'identificationModule': {'nctId': 'NCT05795868', 'briefTitle': 'The Effect of Compression Stockings on the Complaints of Pregnant Women With Restless Leg Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'The Effect of Compression Stockings on the Complaints, Well-Being and Sleep Quality of Pregnant Women With Restless Legs Syndrome', 'orgStudyIdInfo': {'id': '221S452'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Compression stockings group', 'description': 'Pregnant women in the compression stockings group will wear the socks given for 3 weeks.', 'interventionNames': ['Device: Compression stocks']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo sock group', 'description': 'Pregnant women in the placebo socks group will wear the socks given for 3 weeks.', 'interventionNames': ['Other: Knee socks']}], 'interventions': [{'name': 'Compression stocks', 'type': 'DEVICE', 'description': 'Pregnant women in the compression stockings group will wear the socks given for 3 weeks.', 'armGroupLabels': ['Compression stockings group']}, {'name': 'Knee socks', 'type': 'OTHER', 'description': 'Pregnant women in the Knee socks group will wear the socks given for 3 weeks.', 'armGroupLabels': ['Placebo sock group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38280', 'city': 'Kayseri', 'country': 'Turkey (Türkiye)', 'facility': 'Özlem Kaplan', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}, {'city': 'Kayseri', 'country': 'Turkey (Türkiye)', 'facility': 'Erciyes University', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Will be shared after the study ends.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TC Erciyes University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Scientific and Technological Research Council of Turkey', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Reserch Asistant', 'investigatorFullName': 'Ozlem Kaplan', 'investigatorAffiliation': 'TC Erciyes University'}}}}