Transcutaneous Electrical Nerve Stimulation (TENS) for IUD Insertion Pain

ID#: NCT06245655

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: March 18, 2024

End Date: February 01, 2025

Contact Information:
Lauren Kus, MD
(260) 409-6622
Shanell Morrison, MPH

This study is a double-blind, randomized, placebo-controlled trial to evaluate the use of high frequency TENS for pain control during IUD insertion. Transcutaneous electrical nerve stimulation (TENS) is a relatively low-cost, low-risk, non-pharmacologic intervention for pain management. Previous studies have found that TENS reduces pain associated with other outpatient gynecological procedures. Participants will be randomized in a 1:1 ratio to either active treatment or placebo (placebo TENS) and record pain scores using a 100 mm visual analog scale (VAS) at the time of IUD insertion. The same device will be used for both active and placebo treatment.


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