[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06969365":3,"trial-entities:NCT06969365":86,"trial-summary:NCT06969365":90},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":43,"secondary_outcomes":48,"sex":49,"minimum_age":50,"maximum_age":51,"healthy_volunteers":52,"eligibility_criteria":53,"std_ages":62,"locations":65,"central_contacts":75,"overall_officials":76,"references":80,"see_also_links":85},"NCT06969365","SLHS-24-088","Weighted Blankets for IUD Insertion","Do Weighted Blankets Reduce Pain and Anxiety Associated With Gynecological Procedures?","ENROLLING_BY_INVITATION","2025-10-01","2025-05","2025-05-13","2025-03-01","Saint Luke's Health System","OTHER",false,"When having an intrauterine device placed in an outpatient clinic, patients frequently feel anxiety related to the procedure. This study is designed to determine if the use of a small, weighted blanket, placed over the patient's chest and shoulders, would help decrease that anxiety, as well as pain related to the procedure.","Patients scheduled for an IUD placement in this specific outpatient clinic will be approached by the study nurse to gauge interest in participating. Consented patients will be randomized to either receive a weighted blanket or a non-weighted blanket. Patients will rate their anxiety on a 100 mm visual-analog scale and pain on a 0-10 verbal scale.",[19],"Intra-uterine Device Placement",[21,22,23,24],"weighted blanket","gynecological procedure","IUD","anxiety","INTERVENTIONAL","SUPPORTIVE_CARE",[28],"PHASE1",{"count":30,"type":31},54,"ESTIMATED",[33,38],{"type":14,"name":34,"description":35,"armGroupLabels":36},"10-pound weighted lap-pad","10-pound weighted lap pad will be placed over the patient's chest and shoulders",[37],"Weighted blanket",{"type":14,"name":39,"description":40,"armGroupLabels":41},"blanket","A simple, unweighted blanket will be applied to patients during IUD insertion",[42],"Non-weighted blanket",[44],{"measure":45,"description":46,"timeFrame":47},"Visual Analog Scale - Anxiety","Patients will make a mark on a 100 mm line to indicate level of anxiety","At the conclusion of the procedure",[],"FEMALE","18 Years",null,true,{"inclusion":54,"exclusion":58,"raw_text":61},[55,56,57],"scheduled for IUD placement","age 18 years or older","able to read and understand English and use a pen",[59,60],"inability to consent","inability to remove weighted blanket","Inclusion Criteria:\n\n* scheduled for IUD placement\n* age 18 years or older\n* able to read and understand English and use a pen\n\nExclusion Criteria:\n\n* inability to consent\n* inability to remove weighted blanket",[63,64],"ADULT","OLDER_ADULT",[66],{"facility":67,"city":68,"state":69,"zip":70,"country":71,"geoPoint":72},"Saint Luke's Hospital","Kansas City","Missouri","64111","United States",{"lat":73,"lon":74},39.09973,-94.57857,[],[77],{"name":78,"affiliation":13,"role":79},"Anna Guastello, BSN","PRINCIPAL_INVESTIGATOR",[81],{"pmid":82,"type":83,"citation":84},"31882291","BACKGROUND","Nguyen L, Lamarche L, Lennox R, Ramdyal A, Patel T, Black M, Mangin D. Strategies to Mitigate Anxiety and Pain in Intrauterine Device Insertion: A Systematic Review. J Obstet Gynaecol Can. 2020 Sep;42(9):1138-1146.e2. doi: 10.1016\u002Fj.jogc.2019.09.014. Epub 2019 Dec 25.",[],{"nct_id":4,"conditions":87,"biomarkers":89},[88],"Intrauterine Device Placement",[],{"nct_id":4,"found":15,"summary":51,"prompt_version":51}]