TENS Unit for Analgesia During IUD Insertion (NCT06240260)
🩺 Plain-English Summary (8th-Grade Level)
Subjects will be screened over the phone or in Tufts GYN clinic for participation in the study. If eligible and interested in participating, written informed consent (and assent if applicable) will be obtained. After informed consent/assent, the patient will be enrolled in the study. The patient will decide if they desire to use TENS unit during IUD insertion appointment and inform the study team. The clinic visit will proceed as normal, with additional study proceedings as follows. The study personnel will complete the 'Background Questionnaire' with the patient prior to IUD insertion. During the IUD insertion appointment, study personnel will assist in collection of the 'Study visit' data collection form. This includes recording the patient's pain score at various time points throughout the insertion procedure: * anticipated pain during IUD insertion * baseline pain prior to insertion * speculum insertion * tenaculum placement * paracervical block administration (if performed) * cervical dilation (if performed) * uterine sounding * IUD insertion * 5 minutes after IUD insertion Study personnel will also time the insertion procedure and collect additional data as outlined in the 'Study visit data collection form.' After IUD insertion, the participant will be asked to complete the 'Post-IUD Insertion Survey.' Once this survey is complete, this will conclude the study participation. Participation will last through the study visit only. As part of the standard of care, a urine pregnancy test will be obtained and confirmed negative prior to IUD insertion. Patients will receive routine pain management modalities per shared decision-making with their clinical provider which may include NSAID administration, paracervical block, and heating pad.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (16 items).
Location: Tufts Medical Center — Boston, Massachusetts
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Unable to provide informed consent/assent
- Prior cervical procedure (ie loop electrosurgical excision procedure, LEEP)
- Concurrent cervical or intrauterine procedure (ie colposcopy or dilation and curettage)
- Cutaneous damage at the TENS electrode sites
- Chronic or pre-procedure use of opioids
- Chronic pain diagnosis
- Prior IUD insertion
- Any contraindication to intrauterine device (IUD):
- Pregnancy
- Uterine anomaly that distorts the uterine cavity
- Acute pelvic inflammatory disease (PID)
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Tufts Medical Center — Boston, Massachusetts
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.