Transcutaneous Electrical Nerve Stimulation for Pain Mitigation During Intrauterine Device Placement (NCT06991075) | Clinical Trial Compass
RecruitingNot Applicable
Transcutaneous Electrical Nerve Stimulation for Pain Mitigation During Intrauterine Device Placement
United States86 participantsStarted 2025-12-01
Plain-language summary
Investigators are conducting a study to determine whether high frequency transcutaneous electrical nerve stimulation (hfTENS) is effective at reducing pain in women having an IUD inserted.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Provision of signed and dated informed consent form for IUD Insertion
* Stated willingness to comply with all study procedures
* English speaking individuals aged 18 years or older
* Presenting for IUD initiation during ambulatory care visit at MUSC Women's Health
* Opting for either LNG 52mg or copper T380A IUD
Exclusion Criteria:
* 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
* Planned pain intervention outside standard of care (i.e. paracervical block, misoprotol) OR preprocedure use of non-standard pain medication (i.e. benzodiazepines, marijuana, muscle relaxers, gabapentin, benadryl)
* History of epilepsy
What they're measuring
1
Pain scores reported at IUD insertion
Timeframe: From enrollment until 5 minutes after procedure completion