ACTIVE_NOT_RECRUITING

Transcutaneous Electrical Nerve Stimulation (TENS) for Intrauterine Device (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

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

Quick Facts

Study Start:2025-10-01
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT07044622

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:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Tessa Madden, MD, MPH
PRINCIPAL_INVESTIGATOR
Yale University

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

Collaborators and Investigators

Sponsor: Yale University

  • Tessa Madden, MD, MPH, PRINCIPAL_INVESTIGATOR, Yale University

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 Date2025-10-01
Study Completion Date2025-12

Study Record Updates

Study Start Date2025-10-01
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • IUD
  • TENS

Additional Relevant MeSH Terms

  • Pain