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NCT Number: NCT07714590

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

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.

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Key information

Conditions

Intrauterine Device Placement

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Periumbilical Vibration during Intrauterine Device Placement

Device

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 outcomes

  1. 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,

    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.

Secondary outcomes

  1. Satisfaction of Vibration Therapy

    Time frame: 15 minutes post-procedure

    Participants in the intervention arm will complete a post-procedure questionnaire evaluating satisfaction with the vibration therapy.

  2. Acceptability of Vibration Therapy

    Time frame: 15 minutes post-procedure

    Participants in the intervention arm will complete a post-procedure questionnaire evaluating acceptability of the vibration therapy.

Study contacts

Contact information is provided by the study sponsor or research team.

Madeline Thornton, MD, MPH

CONTACT

[email protected]

(919) 668- 2591

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.