Transcutaneous Electrical Nerve Stimulation (TENS) for IUD Insertion Pain

Description

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

Pain

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Study Overview

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Study Details

Study overview

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.

A Randomized Controlled Trial of Transcutaneous Electrical Nerve Stimulation (TENS) for Treatment of IUD Insertion Pain

Transcutaneous Electrical Nerve Stimulation (TENS) for IUD Insertion Pain

Condition
Pain
Intervention / Treatment

-

Contacts and Locations

New Haven

Center for Women's Health and Midwifery, New Haven, Connecticut, United States, 06519

New Haven

Yale Family Planning Clinic, New Haven, Connecticut, United States, 06519

New York

Mount Sinai Beth Israel, New York, New York, United States, 10003

New York

Mount Sinai West, New York, New York, United States, 10019

New York

Mount Sinai Morningside, New York, New York, United States, 10025

New York

Mount Sinai Hospital, New York, New York, United States, 10029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Presenting for IUD initiation during ambulatory care visits to the Mount Sinai Complex Family Planning service
  • * Provision of signed and dated informed consent form for IUD Insertion
  • * English speaking and age 18 or older
  • * Opting for either LNG 52mg or copper T380A IUD
  • * Stated willingness to comply with all study procedures
  • * Contraindication to IUD initiation (i.e. pregnancy, current pelvic infection, distorted uterine anatomy)
  • * Contraindication or allergy to ibuprofen
  • * History of a chronic pain disorder
  • * Recent opioid use in the previous 30 days
  • * History of a cardiac arrhythmia
  • * History of heart disease (i.e. atrial fibrillation, congestive heart failure)
  • * Presence of an implantable device with an electrical discharge (i.e. pacemaker)
  • * BMI \> 50 (class IV obesity)
  • * History of TENS use

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Icahn School of Medicine at Mount Sinai,

Lauren Kus, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

2025-02