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Effect of Periumbilical Vibration on Pain Perception During Intrauterine Device Insertion: A Randomized Controlled Trial

RecruitingNAAges 18 Years - anyFemaleDuke University
NCT07714590 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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? Researchers will compare pain scores during IUD insertion among patients who received the vibrating device at the umbilicus and those who did not. Participants 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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * Currently pregnant * Planned use of IV sedation during IUD placement * Inability to provide informed consent due to disability or language barrier
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What it tests

  • Periumbilical Vibration during Intrauterine Device Placement
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Where

1 site
Duke University Hospital
Durham, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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