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Completed
NCT06245655
Transcutaneous Electrical Nerve Stimulation (TENS) for IUD Insertion Pain
Conditions: Pain
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 99
Sponsor: Icahn School of Medicine at Mount Sinai
Location: Center for Women's Health and Midwifery New Haven Connecticut
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.
Eligibility Criteria
Inclusion Criteria:
In order to participate in the study, an individual must meet all the following 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
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) OR pre-procedure use of non-standard pain medication (i.e. benzodiazepines, muscle relaxers, gabapentin, benadryl)
* History of epilepsy
Source: ClinicalTrials.gov (NCT06245655). StuddyBuddy aggregates publicly available trial information.