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NCT06245655Recruiting

Transcutaneous Electrical Nerve Stimulation (TENS) for IUD Insertion Pain

A Randomized Controlled Trial of Transcutaneous Electrical Nerve Stimulation (TENS) for Treatment of IUD Insertion Pain
Icahn School of Medicine at Mount SinaiClinicalTrials.govdeviceDevice trial
Study focus
Disease/Condition
Pain
Drug/Device/Intervention
Transcutaneous Electrical Nerve Stimulation (TENS)
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Icahn School of Medicine at Mount Sinai
Location
New York,New York,New York,New York, United States of America
Timeline & enrollment
Phase
N/A
Start date
Mar 18, 2024
End date
Feb 01, 2025
Enrollment
98 participants
Primary outcome

Pain Visual Analog Scale

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.

ICD-10 classifications
Pain, unspecifiedPain, not elsewhere classifiedPain in limbAcute painOther chronic pain
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06245655
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06245655 through Pure Global AI's free database. This phase not specified trial is sponsored by Icahn School of Medicine at Mount Sinai and is currently Recruiting. The study focuses on Pain. Target enrollment is 98 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.