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

Conditions

• Intrauterine Device Placement

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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 Dates

First listed

Jul 20, 2026

Start date

Jul 13, 2026

Status verified

Jul 2026

Primary completion

Jul 1, 2027

Completion

Jul 1, 2027

Study Design

Enrollment

114 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

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

• Madeline Thornton, MD, MPH
  (919) 668- 2591
  [email protected]

Locations (1)

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