COMPLETED

Transcutaneous Electrical Nerve Stimulation (TENS) for IUD Insertion Pain

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-03-25
Study Completion:2025-04-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06245655

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Presenting for IUD initiation during ambulatory care visits to the Mount Sinai Complex Family Planning service
  2. * Provision of signed and dated informed consent form for IUD Insertion
  3. * English speaking and age 18 or older
  4. * Opting for either LNG 52mg or copper T380A IUD
  5. * Stated willingness to comply with all study procedures
  1. * Contraindication to IUD initiation (i.e. pregnancy, current pelvic infection, distorted uterine anatomy)
  2. * Contraindication or allergy to ibuprofen
  3. * History of a chronic pain disorder
  4. * Recent opioid use in the previous 30 days
  5. * History of a cardiac arrhythmia
  6. * History of heart disease (i.e. atrial fibrillation, congestive heart failure)
  7. * Presence of an implantable device with an electrical discharge (i.e. pacemaker)
  8. * BMI \> 50 (class IV obesity)
  9. * History of TENS use
  10. * Planned pain intervention outside standard of care (i.e. paracervical block) OR pre-procedure use of non-standard pain medication (i.e. benzodiazepines, muscle relaxers, gabapentin, benadryl)
  11. * History of epilepsy

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

Center for Women's Health and Midwifery
New Haven, Connecticut, 06519
United States
Yale Family Planning Clinic
New Haven, Connecticut, 06519
United States
Mount Sinai Beth Israel
New York, New York, 10003
United States
Mount Sinai Union Square
New York, New York, 10003
United States
Mount Sinai Hospital
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-25
Study Completion Date2025-04-21

Study Record Updates

Study Start Date2024-03-25
Study Completion Date2025-04-21

Terms related to this study

Additional Relevant MeSH Terms

  • Pain