Transcutaneous Electrical Nerve Stimulation (TENS) for IUD Insertion Pain

Completed · Not applicable · Has a placebo group

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT06245655

Run by

Icahn School of Medicine at Mount Sinai

People needed

99

Starts

2024-03-25

Expected to finish

2025-04-21

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

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

Full record on ClinicalTrials.gov

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