Transcutaneous Electrical Nerve Stimulation (TENS) for IUD Insertion Pain
Study Phase: N/A
Recruitment Status: Recruiting
Start Date: March 18, 2024
End Date: February 01, 2025
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