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Transcutaneous Electrical Nerve Stimulation (TENS) for IUD Insertion Pain
Sponsor: Icahn School of Medicine at Mount Sinai
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.
Official title: A Randomized Controlled Trial of Transcutaneous Electrical Nerve Stimulation (TENS) for Treatment of IUD Insertion Pain
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
99
Start Date
2024-03-25
Completion Date
2025-04-21
Last Updated
2026-07-06
Healthy Volunteers
No
Conditions
Interventions
Transcutaneous Electrical Nerve Stimulation (TENS)
TENS 7000 digital TENS unit, 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.
Locations (5)
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