Recruiting

Vibrating Device

Sponsor:

Duke University

Code:

NCT07714590

Conditions

Intrauterine Device Placement

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Periumbilical Vibration during Intrauterine Device Placement

Study Details

Brief summary:

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.

Conditions

Intrauterine Device Placement

Study ID

NCT07714590

Start date

Oct 9, 2026

Status verified date

Oct, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

114 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Periumbilical Placement of Vibrating Device

Participants assigned to this arm will have a handheld vibrating device placed at the umbilicus during intrauterine device insertion procedure.

no intervention: Standard of Care

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.

Interventions

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.

Primary outcome measure

  • Pain score [ Time Frame: 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, ]

Central Contacts and Locations

Central contacts

Madeline Thornton, MD, MPH

(919) 668- 2591madeline.thornton@duke.edu

Locations

Duke University Hospital

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Beverly Gray, MD

(919) 668- 2591beverly.gray@duke.edu

Kristin Weaver

919-681-0308kristin.weaver@duke.edu

More Information

Sponsor

Duke University

Last update posted

Oct 19, 2026

Last verified

Oct, 2026

Keywords

  • intrauterine device

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-20. This information was provided to ClinicalTrials.gov by Duke University on 2026-10-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.