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 range
18 Years
Sex
FEMALE
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.