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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorDuke University

About this 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Currently pregnant

Planned use of IV sedation during IUD placement

Inability to provide informed consent due to disability or language barrier

Trial design

Treatments tested in this trial

  • Periumbilical Vibration during Intrauterine Device Placement

Treatment groups

114 Participants
are divided into 2 treatment groups

Sponsors and collaborators