Study of TENS Unit Use for Pain Relief During Intrauterine Device IUD Insertion in Females Aged 12 to 50

What this Trial Is About

Researchers are evaluating the use of a Transcutaneous Electrical Nerve Stimulation TENS unit to help manage pain during intrauterine device IUD insertion. This prospective cohort study compares patients who choose to use the TENS device during the procedure with those who decline it, aiming to understand its effect on pain relief and patient preference for analgesia methods. The study is led by Tufts Medical Center and includes female participants aged 12 to 50 years who desire IUD insertion and are able to give consent or assent. Participants can decide whether to use the TENS unit during their IUD insertion appointment. The procedure follows standard clinical care, including optional pain management such as NSAIDs, paracervical blocks, or heating pads. The study collects pain scores at several points during the insertion process, including anticipated pain, baseline pain, speculum insertion, tenaculum placement, paracervical block administration if used, cervical dilation if performed, uterine sounding, IUD insertion, and five minutes after insertion. The procedure duration is timed, and additional data are gathered during the visit. During the study visit, participants complete a background questionnaire before the IUD insertion and a post-insertion survey afterward. A urine pregnancy test is done as part of standard care to confirm a negative result before insertion. Researchers monitor pain intensity as the primary outcome and also record vasovagal responses and participants likelihood to recommend their pain management method. Participation lasts through the single study visit, with no extended follow-up periods.

TENS Unit for Analgesia During IUD Insertion