Clinical Trial

Transcutaneous Electrical Nerve Stimulation (TENS) for Intrauterine Device (IUD) Insertion Pain

Withdrawn
View on ClinicalTrials.gov →
Why the trial stopped
Null findings from similar study.
Summary
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2025-06-23; most recent amendment 2026-02-11.
Status change: Active, Not Recruiting → Withdrawn 2026-02-11
Status change: Not Yet Recruiting → Active, Not Recruiting 2025-11-25
Status change: Recruiting → Not Yet Recruiting 2025-09-22
Trial Details
NCT Number NCT07044622
Lead Sponsor Yale University
Collaborators: Society of Family Planning
Conditions Pain
Start Date 2025-10-01
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-02-13