Using TENS to reduce pain during IUD insertion

A Randomized Controlled Trial of Transcutaneous Electrical Nerve Stimulation (TENS) for Treatment of IUD Insertion Pain

This study is testing if a special pain-relief device can help women feel less discomfort during IUD insertion compared to a placebo.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 98 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Icahn School of Medicine at Mount Sinai (other)
• Locations: 7 sites (New Haven, Connecticut and 6 other locations)
• Trial ID: NCT06245655 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of high frequency Transcutaneous Electrical Nerve Stimulation (TENS) for managing pain during IUD insertion. It is a double-blind, randomized, placebo-controlled trial where participants will be assigned to receive either active TENS treatment or a placebo. Pain levels will be measured using a visual analog scale at the time of the procedure. The study aims to recruit eligible participants from the Mount Sinai Complex Family Planning service and other locations, ensuring a rigorous approach to data collection and analysis.

Who should consider this trial

Good fit: Ideal candidates are English-speaking women aged 18 or older who are seeking IUD initiation at participating clinics.

Not a fit: Patients with contraindications to IUD insertion or those with certain medical histories, such as chronic pain disorders or recent opioid use, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a low-cost, non-pharmacologic option for pain management during IUD insertion.

How similar studies have performed: Previous studies have shown that TENS can effectively reduce pain in other outpatient gynecological procedures, suggesting potential success for this approach.

Eligibility criteria

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

Where this trial is running

New Haven, Connecticut and 6 other locations

• Center for Women's Health and Midwifery — New Haven, Connecticut, United States (RECRUITING)
• Yale Family Planning Clinic — New Haven, Connecticut, United States (RECRUITING)
• Mount Sinai Beth Israel — New York, New York, United States (RECRUITING)
• Mount Sinai Union Square — New York, New York, United States (NOT_YET_RECRUITING)
• Mount Sinai West — New York, New York, United States (WITHDRAWN)
• Mount Sinai Morningside — New York, New York, United States (WITHDRAWN)
• Mount Sinai Hospital — New York, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Lauren Kus, MD — Icahn School of Medicine at Mount Sinai
• Study coordinator: Shanell Morrison, MPH

Conditions: Pain