[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07714590":3,"trial-entities:NCT07714590":126,"trial-summary:NCT07714590":129},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":40,"sex":48,"minimum_age":49,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":50,"std_ages":61,"locations":64,"central_contacts":80,"overall_officials":84,"references":88,"see_also_links":125},"NCT07714590","Pro00118748","Effect of Periumbilical Vibration on Pain Perception During Intrauterine Device Insertion: A Randomized Controlled Trial","NOT_YET_RECRUITING","2027-07-01","2026-07","2026-07-20","2026-07-13","Duke University","OTHER",false,"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.",null,[18],"Intrauterine Device Placement",[20],"intrauterine device","INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},114,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"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.",[34],"Periumbilical Placement of Vibrating Device",[36],{"measure":37,"description":38,"timeFrame":39},"Pain score","Perceived pain will be assessed using a 100-point visual analog scale (VAS). The VAS ranges from 0 to 100 with the lower score indicating less pain and the higher score indicating greater pain.","Pain will be assessed using a 100-point Visual Analog Scale (VAS) at multiple time points during and after the procedure (pre-procedure, with speculum placement, with tenaculum placement, immediately after uterine sound, immediately after IUD placement,",[41,45],{"measure":42,"description":43,"timeFrame":44},"Satisfaction of Vibration Therapy","Participants in the intervention arm will complete a post-procedure questionnaire evaluating satisfaction with the vibration therapy.","15 minutes post-procedure",{"measure":46,"description":47,"timeFrame":44},"Acceptability of Vibration Therapy","Participants in the intervention arm will complete a post-procedure questionnaire evaluating acceptability of the vibration therapy.","FEMALE","18 Years",{"inclusion":51,"exclusion":56,"raw_text":60},[52,53,54,55],"Age 18 years or older","Capable of providing informed consent","Scheduled for IUD insertion at either Duke 1J gynecology clinic or Family Planning clinic","English-speaking",[57,58,59],"Currently pregnant","Planned use of IV sedation during IUD placement","Inability to provide informed consent due to disability or language barrier","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",[62,63],"ADULT","OLDER_ADULT",[65],{"facility":66,"city":67,"state":68,"zip":69,"country":70,"contacts":71,"geoPoint":77},"Duke University Hospital","Durham","North Carolina","27705","United States",[72],{"name":73,"role":74,"phone":75,"email":76},"Beverly Gray, MD","CONTACT","(919) 668- 2591","beverly.gray@duke.edu",{"lat":78,"lon":79},35.99403,-78.89862,[81],{"name":82,"role":74,"phone":75,"email":83},"Madeline Thornton, MD, MPH","madeline.thornton@duke.edu",[85],{"name":73,"affiliation":86,"role":87},"Duke Health","PRINCIPAL_INVESTIGATOR",[89,92,95,98,101,104,107,110,113,116,119,122],{"type":90,"citation":91},"BACKGROUND","Mckenzie N, Barnhart K. (044) AN INNOVATIVE AND NON-INVASIVE METHOD OF REDUCING PAIN UTILIZING VIBRATION DURING IUD INSERTION: PATIENT REACTIONS AND ONE PROVIDER'S APPROACH. The Journal of Sexual Medicine. 2024;21(Supplement_5):qdae054.042. doi:10.1093\u002Fjsxmed\u002Fqdae054.042",{"pmid":93,"type":90,"citation":94},"39575620","Wu J, Lim S, Scott A, Hayes T, Unnithan S, Erkanli A, Havrilesky LJ, Swartz JJ. Transcutaneous Electric Nerve Stimulation for Analgesia During Outpatient Endometrial Biopsy: A Randomized Controlled Trial. Obstet Gynecol. 2025 Jan 1;145(1):e14-e23. doi: 10.1097\u002FAOG.0000000000005727. Epub 2024 Nov 21.",{"pmid":96,"type":90,"citation":97},"28079781","Lison JF, Amer-Cuenca JJ, Piquer-Marti S, Benavent-Caballer V, Bivia-Roig G, Marin-Buck A. Transcutaneous Nerve Stimulation for Pain Relief During Office Hysteroscopy: A Randomized Controlled Trial. Obstet Gynecol. 2017 Feb;129(2):363-370. doi: 10.1097\u002FAOG.0000000000001842.",{"pmid":99,"type":90,"citation":100},"34352845","Lerma K, Goldthwaite LM, Blumenthal PD, Shaw KA. Transcutaneous Electrical Nerve Stimulation for Pain Management of Aspiration Abortion up to 83 Days of Gestation: A Randomized Controlled Trial. Obstet Gynecol. 2021 Sep 1;138(3):417-425. doi: 10.1097\u002FAOG.0000000000004502.",{"pmid":102,"type":90,"citation":103},"33833179","Hwang LK, Nash DW, Yedlin A, Greige N, Larios-Valencia J, Choice C, Pothula A. The Effect of Vibration on Pain During Intravenous Injection of Propofol: A Randomized Controlled Trial. Ann Plast Surg. 2021 Jul 1;87(1s Suppl 1):S36-S39. doi: 10.1097\u002FSAP.0000000000002827.",{"pmid":105,"type":90,"citation":106},"22134226","Baxter AL, Cohen LL, McElvery HL, Lawson ML, von Baeyer CL. An integration of vibration and cold relieves venipuncture pain in a pediatric emergency department. Pediatr Emerg Care. 2011 Dec;27(12):1151-6. doi: 10.1097\u002FPEC.0b013e318237ace4.",{"pmid":108,"type":90,"citation":109},"35102735","Casale R, Hansson P. The analgesic effect of localized vibration: a systematic review. Part 1: the neurophysiological basis. Eur J Phys Rehabil Med. 2022 Apr;58(2):306-315. doi: 10.23736\u002FS1973-9087.22.07415-9. Epub 2022 Feb 1.",{"pmid":111,"type":90,"citation":112},"40348315","Dempsey A, Aucoin C, Stallings W, Kulangara A, Sundstrom B. Beyond pain medication: striving toward more patient-centered placement of intrauterine devices. Contraception. 2025 Aug;148:110944. doi: 10.1016\u002Fj.contraception.2025.110944. Epub 2025 May 8.",{"pmid":114,"type":90,"citation":115},"38586685","Rahman M, King C, Saikaly R, Sosa M, Sibaja K, Tran B, Tran S, Morello P, Yeon Seo S, Yeon Seo Y, Jacobs RJ. Differing Approaches to Pain Management for Intrauterine Device Insertion and Maintenance: A Scoping Review. Cureus. 2024 Mar 8;16(3):e55785. doi: 10.7759\u002Fcureus.55785. eCollection 2024 Mar.",{"pmid":117,"type":90,"citation":118},"31882291","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.",{"pmid":120,"type":90,"citation":121},"36961099","Lopes-Garcia EA, Carmona EV, Monteiro I, Bahamondes L. Assessment of pain and ease of intrauterine device placement according to type of device, parity, and mode of delivery. Eur J Contracept Reprod Health Care. 2023 Jun;28(3):163-167. doi: 10.1080\u002F13625187.2023.2189500. Epub 2023 Mar 24.",{"pmid":123,"type":90,"citation":124},"34223223","Kavanaugh ML, Pliskin E. Use of contraception among reproductive-aged women in the United States, 2014 and 2016. F S Rep. 2020 Jul 9;1(2):83-93. doi: 10.1016\u002Fj.xfre.2020.06.006. eCollection 2020 Sep.",[],{"nct_id":4,"conditions":127,"biomarkers":128},[18],[],{"nct_id":4,"found":130,"summary":131,"prompt_version":141},true,{"design":132,"status":133,"heading":134,"summary":135,"follow_up":136,"word_count":137,"commitments":138,"compensation":139,"drugs_mentioned":140},"This is a randomized controlled trial planning to enroll 114 women. Participants will be randomly assigned to either receive a vibrating device or not during IUD insertion.","completed","Periumbilical Vibration for Pain During IUD Insertion","This study is looking at whether a vibrating device placed on your belly button (umbilicus) can help reduce pain when you get an intrauterine device (IUD) inserted. Researchers want to see if using this device makes the IUD insertion process less painful compared to not using it. You would be randomly assigned to either receive the vibrating device or not, and your pain levels will be measured at different times during and after the procedure. All participants can still use standard pain relief options if they wish. This study is for women aged 18 and older who are scheduled for an IUD insertion and can speak English.","Pain will be assessed at multiple time points during and immediately after the procedure.",107,"You would have a vibrating device placed on your belly button during your IUD insertion, or not, depending on your random assignment. Your pain will be assessed at multiple times during and after the procedure.","Not stated in the trial record.",[],"v2"]