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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.

Study design
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.
What's involved
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.
Compensation
Not stated in the trial record.
Follow-up
Pain will be assessed at multiple time points during and immediately after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07714590

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

Not Yet Recruiting
NAAges 18+InterventionalTreatment
Duke University
~114 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:Periumbilical Vibration during Intrauterine Device Placement

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pain score
Measured over 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,

Conditions

Intrauterine Device Placement

Explore related trials

Intrauterine Device Placement

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Beverly Gray, MD · PRINCIPAL_INVESTIGATOR · Duke Health

Who to contact

Madeline Thornton, MD, MPH
[email protected]
(919) 668- 2591
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Currently pregnant
Planned use of IV sedation during IUD placement
Inability to provide informed consent due to disability or language barrier

What this trial measures

  • Pain scorePain 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,

    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.