[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616700":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":52,"collaborators":19,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":19,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":80,"overallStatus":87,"whyStopped":19,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Ataturk University","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"This is a self-controlled randomized study.","This study is designed to evaluate the effect of weighted blankets on lower leg cramps, sleep quality, anxiety and stress in pregnant women, assessing both the control group and the intervention group. This study is planned as a randomised self-controlled trial. This method was specifically chosen for the study design. The single-group approach allows for comparisons within each individual, significantly reducing the impact of personal differences. This minimises any bias that may arise from inter-individual variability. Furthermore, as multidimensional variables such as the lifestyle habits of pregnant women, their level of physical activity, dietary patterns, and environmental factors affecting sleep patterns have the potential to obscure the results of the study, this method aims to minimise the impact of these factors.",[12],"Device: Weighted Blanket",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","Weighted Blanket","The intervention involves the use of a weighted blanket designed to provide deep pressure stimulation during sleep. Each participant will first complete a 2-week control period with routine sleep conditions, during which baseline data will be collected. Immediately following this phase, participants will use the weighted blanket nightly for 2 weeks. No wash-out period will be applied between phases. Outcomes such as lower leg cramps, sleep quality, anxiety, and stress levels will be assessed and compared between the control and intervention periods within the same participants.",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Serap EJDER APAY, Professor","Atatürk University Faculty of Health Sciences, Department of Midwifery","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"ELİF ERDOĞAN, Mcs","CONTACT","+905076751643","eliferdogan@atauni.edu.tr",[32],{"facility":33,"status":19,"city":34,"state":35,"zip":36,"country":37,"countryCode":19,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Atatürk University Instiute of Health Sciences, Department of Midwifery","Erzurum","Lütfen Seçiniz.","25010","Turkey (Türkiye)",{"type":39,"coordinates":40},"Point",[41,42],41.27694,39.90861,{"lat":42,"lon":41},[45,49],{"name":46,"role":28,"phone":47,"phoneExt":48,"email":30},"ELİF ERDOĞAN, MSc","05076751643","+90",{"name":50,"role":28,"phone":19,"phoneExt":19,"email":51},"Serap Ejder Apay, Professor","serapejder@atauni.edu.tr",{"type":24,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Serap Ejder Apay","Professor of Midwifery and Head of the Department of Midwifery","100616700","weighted-blanket-in-pregnancy-100616700",false,"NCT07309016","Weighted Blanket in Pregnancy","The Effect of a Weighted Blanket on Lower Leg Cramps, Sleep Quality, Anxiety, and Stress in Pregnant Women: A Randomized Controlled Trial","Weighted","Inclusion Criteria:\n\n* Primarily pregnant women between the ages of 18 and 40 ,\n* Low BMI (to be able to use 8kg weighted blanket),\n* Gestational week ≥ 28,\n* Third trimester pregnant women,\n* Singleton pregnancy,\n* Ability to communicate verbally and in writing in Turkish,\n* Willingness to participate in research and comply with intervention protocols..\n\nExclusion Criteria:\n\n* Those who have been diagnosed with high-risk pregnancy,\n* Preeclampsia or eclampsia, placenta previa,\n* Gestational diabetes requiring insulin,\n* Diagnosis of fetal growth retardation,\n* Polyhydramnios or oligohydramnios, asthma , sleep apnea or serious heart\u002Fcirculatory problems,\n* History of bleeding during pregnancy,\n* Obstetric complications requiring close medical monitoring.\n* Multiple pregnancies,\n* Previously diagnosed with a sleep disorder,\n* Having been diagnosed with a psychiatric disorder\n* Multiparous pregnant women,\n* Pregnant women in the first two trimesters ,\n* Night shift workers",true,"FEMALE","18 Years","40 Years",{"count":68,"type":69},50,"ESTIMATED","INTERVENTIONAL",[72],"NA","Pregnancy is frequently accompanied by sleep disturbances, musculoskeletal discomfort, anxiety, and stress, which may negatively affect maternal well-being and daily functioning. Weighted blankets, which provide deep pressure stimulation, have been used as a non-pharmacological method to promote relaxation, improve sleep quality, and reduce stress and anxiety. However, their effects have not been evaluated in pregnant women. This study aims to examine the effect of weighted blanket use on lower leg cramps, sleep quality, anxiety, and stress levels among pregnant women. The trial uses a randomized, self-controlled design in which each participant completes a 14-day control period without the blanket and a subsequent 14-day intervention period using the weighted blanket. Data will be collected using validated measurement tools. The findings are expected to provide evidence for a safe, non-pharmacological supportive approach that may enhance comfort and psychological well-being during pregnancy.",[75,76,77,78,79],"Leg Cramps, Nocturnal","Poor Sleep Quality","Pregnancy","Anxiety","Stress",[81,82,83,84,85,86],"Weighted blanket","sleep","anxiety","stress","cramps","pregnancy","NOT_YET_RECRUITING","2025-12-15",{"date":90,"type":91},"2025-12-30","ACTUAL",{"date":90,"type":69},{"date":94,"type":69},"2027-05-17",{"name":5,"class":6},1]