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Could a simple TENS device ease IUD insertion pain?

NCT ID NCT06245655

Symptom relief Sponsor: Icahn School of Medicine at Mount Sinai Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This trial investigates whether a transcutaneous electrical nerve stimulation (TENS) device can reduce pain during IUD insertion. About 99 women receiving an IUD will be randomly assigned to either an active TENS unit or a placebo device. Participants will rate their pain on a scale, and researchers will compare the two groups to see if TENS provides meaningful relief.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Transcutaneous Electrical Nerve Stimulation (TENS) device
What this could lead to
If effective, TENS could offer a low-cost, drug-free option to ease pain during IUD insertion.
What could go wrong
This is a small, early-stage trial, and results may not confirm benefit. Pain relief from TENS varies widely among individuals.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

99 people

The number who actually took part.

Started

Mar 2024

Finished

Apr 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: In order to participate in the study, an individual must meet all the following criteria: * Presenting for IUD initiation during ambulatory care visits to the Mount Sinai Complex Family Planning service * Provision of signed and dated informed consent form for IUD Insertion * English speaking and age 18 or older * Opting for either LNG 52mg or copper T380A IUD * Stated willingness to comply with all study procedures Exclusion Criteria: * Contraindication to IUD initiation (i.e. pregnancy, current pelvic infection, distorted uterine anatomy) * Contraindication or allergy to ibuprofen * History of a chronic pain disorder * Recent opioid use in the previous 30 days * History of a cardiac arrhythmia * History of heart disease (i.e. atrial fibrillation, congestive heart failure) * Presence of an implantable device with an electrical discharge (i.e. pacemaker) * BMI \> 50 (class IV obesity) * History of TENS use * Planned pain intervention outside standard of care (i.e. paracervical block) OR pre-procedure use of non-standard pain medication (i.e. benzodiazepines, muscle relaxers, gabapentin, benadryl) * History of epilepsy

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Conditions

The condition(s) this trial relates to.

Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pain

Contacts and locations

Locations

  • Center for Women's Health and Midwifery

    New Haven, Connecticut, 06519, United States

  • Mount Sinai Beth Israel

    New York, New York, 10003, United States

  • Mount Sinai Hospital

    New York, New York, 10029, United States

  • Mount Sinai Union Square

    New York, New York, 10003, United States

  • Yale Family Planning Clinic

    New Haven, Connecticut, 06519, United States

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