CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Transcutaneous electrical nerve stimulation (TENS) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06335823
NCT06335823N/ACompleted

Randomized, Placebo-Controlled Study on the Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Reduction During Intrauterine Device (IUD) Insertion in Outpatient Gynecology

University Hospitals Cleveland Medical Center·interventional·Posted Mar 28, 2024·Updated Mar 2, 2026

In Brief

A clinical study evaluating Transcutaneous electrical nerve stimulation (TENS) and Placebo Transcutaneous electrical nerve stimulation (TENS) for IUD Insertion Pain. Completed, enrolled 60 participants across 1 site.

Detailed Summary

Pain with intrauterine device (IUD) insertion is very common and there are few options for patients to help reduce this pain. Transcutaneous electric nerve stimulators (TENS) are a non-invasive procedure that may help reduce the pain with IUD insertions. The investigators hope that the information gleaned from this study will result in pain control options for future patients who desire an IUD placement.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20252026
First PostedMar 28, 2024
Enrollment StartJun 5, 2024
Primary CompletionFeb 7, 2025
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 2.3 years ago

Interventions

Transcutaneous electrical nerve stimulation (TENS)device

All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit turned on and half will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.

Placebo Transcutaneous electrical nerve stimulation (TENS)device

All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit will not be turned on.