[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647780":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":53,"collaborators":18,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":18,"eligibilityCriteria":60,"healthyVolunteers":57,"sex":61,"minAge":62,"maxAge":18,"enrollmentInfo":63,"targetDuration":18,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":74,"whyStopped":18,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Duke University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Periumbilical Placement of Vibrating Device","EXPERIMENTAL","Participants assigned to this arm will have a handheld vibrating device placed at the umbilicus during intrauterine device insertion procedure.",[13],"Device: Periumbilical Vibration during Intrauterine Device Placement",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care","NO_INTERVENTION","Participants assigned to this arm will not have a vibrating device placed at the umbilicus during intrauterine device placement. They will receive standard of care.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Periumbilical Vibration during Intrauterine Device Placement","Participants will be randomly assigned to receive a vibrating device placed on the belly button during IUD insertion or not. All participants will be able to use standard of care pain control measures during the IUD insertion procedure as desired, even if randomized to receive the vibrating device.",[9],[26],{"name":27,"affiliation":28,"role":29},"Beverly Gray, MD","Duke Health","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Madeline Thornton, MD, MPH","CONTACT","(919) 668- 2591","madeline.thornton@duke.edu",[37],{"facility":38,"status":18,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Duke University Hospital","Durham","North Carolina","27705","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-78.89862,35.99403,{"lat":48,"lon":47},[51],{"name":27,"role":33,"phone":34,"phoneExt":18,"email":52},"beverly.gray@duke.edu",{"type":54,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100647780","effect-of-periumbilical-vibration-on-pain-perception-during-intrauterine-device-insertion-a-randomized-controlled-trial-100647780",false,"NCT07714590","Effect of Periumbilical Vibration on Pain Perception During Intrauterine Device Insertion: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 18 years or older\n* Capable of providing informed consent\n* Scheduled for IUD insertion at either Duke 1J gynecology clinic or Family Planning clinic\n* English-speaking\n\nExclusion Criteria:\n\n* Currently pregnant\n* Planned use of IV sedation during IUD placement\n* Inability to provide informed consent due to disability or language barrier","FEMALE","18 Years",{"count":64,"type":65},114,"ESTIMATED","INTERVENTIONAL",[68],"NA","The goal of this randomized controlled trial is to learn if placing a vibrating device at the umbilicus during insertion of intrauterine device (IUD) decreases perceived pain during the procedure. The main question it aims to answer is: Does applying a vibrating device to the umbilicus during IUD insertion significantly reduce perceived pain compared to standard of care?\n\nResearchers will compare pain scores during IUD insertion among patients who received the vibrating device at the umbilicus and those who did not.\n\nParticipants will be randomly assigned to receive a vibrating device placed on the umbilicus during IUD insertion or not. All participants will be able to use standard of care pain control measures during the IUD insertion procedure as desired, even if randomized to receive the vibrating device. Participants will complete a pre-procedure survey and will report their pain on a scale of 1-100 at various points during the IUD insertion procedure. Participants who received the vibrating device will also complete a post-procedure survey.",[71],"Intrauterine Device Placement",[73],"intrauterine device","NOT_YET_RECRUITING","2026-08-19",{"date":77,"type":78},"2026-08-20","ACTUAL",{"date":80,"type":65},"2026-09-01",{"date":82,"type":65},"2027-07-01",{"name":5,"class":6},1]