WithdrawnNot Applicable

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

Stopped: Null findings from similar study.

United States0Started 2025-10-01

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria Patient Participants: * Provision of signed and dated informed consent form. * Stated willingness to comply with all study procedures and availability for the duration of the study. * English-speaking individual aged 18 years or older. * Presenting for IUD initiation or replacement during ambulatory care visits to the Yale Family Planning service and Center for Women's Health and Midwifery clinic. * Opting for either LNG 52mg or copper T380A IUD. Inclusion Criteria Provider Participants: * Review of the provider participant study Information Sheet and provision of verbal consent. * IUD insertion performed by Yale Family Planning and Center for Women's Health and Midwifery clinic faculty and fellows, as well as OB/GYN residents on their family planning rotation, with IUD insertion competency. * Performing an IUD insertion on a patient participant who meets all patient participant eligibility criteria Exclusion Criteria Patient Participants: * Contraindication to IUD initiation * Current Pelvic Infection * Distorted Uterine Anatomy (I.e., uterine septum, didelphys, uterine fibroids with cavity length greater than 12mm) * Pregnancy * Any other contraindications to IUD insertion as determined by the patient's clinical care staff. * Exclusionary criteria for study participation * Current IUD with no visible strings * Contraindication or allergy to ibuprofen * History of chronic pain disorder * Recent opioid use in the previous 30 days * History of cardiac a…

What they're measuring

Pain reported on Visual Analog Scale (VAS)

Timeframe: Day 1 (Day of IUD insertion)

Trial details

NCT IDNCT07044622

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12