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

NCT07044622 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2026-02-13

No results posted yet for this 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.

Conditions

Interventions

DEVICE

Transcutaneous Electrical Nerve Stimulation (TENS)

The TENS 7000 digital TENS unit is a low cost, over the counter, battery operated device with high consumer ratings. The handheld device works by transmitting an electronically generated topical stimulus to a specified area on the body to alter response to pain signals and promote endogenous endorphin release for pain reduction.

DEVICE

Transcutaneous Electrical Nerve Stimulation (TENS)

The TENS 7000 digital TENS unit is a low cost, over the counter, battery operated device with high consumer ratings. The handheld device works by transmitting an electronically generated topical stimulus to a specified area on the body to alter response to pain signals and promote endogenous endorphin release for pain reduction.

Sponsors & Collaborators

Principal Investigators

  • Tessa Madden, MD, MPH · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07044622 on ClinicalTrials.gov