Effect of Periumbilical Vibration on Pain Perception During Intrauterine Device Insertion: A Randomized Controlled Trial
Starting soon · Not applicable
Conditions studied: Intrauterine Device Placement
In brief
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 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.
Key facts
- Study ID
- NCT07714590
- Run by
- Duke University
- People needed
- 114
- Starts
- 2026-07-13
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2026-07-20
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Currently pregnant
- Planned use of IV sedation during IUD placement
- Inability to provide informed consent due to disability or language barrier
Where it is running
- Duke University Hospital — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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