Using TENS units to reduce pain during IUD insertion

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of transcutaneous electrical nerve stimulation (TENS) units in managing pain during the insertion of intrauterine devices (IUDs). Eligible participants, aged 12 to 50, will be screened and consented before deciding whether to use the TENS unit during their IUD insertion appointment. Pain levels will be assessed at various stages of the procedure to determine the impact of TENS on pain management. The study aims to provide insights into patient preferences and pain experiences associated with IUD insertion.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Persons with a uterus desiring insertion of intrauterine device
2. Able to provide informed consent/assent
3. Age 12-50 years old
4. Minors 12 years of age and older will be included in the study if postmenarchal

Exclusion Criteria:

1. Unable to provide informed consent/assent
2. Prior cervical procedure (ie loop electrosurgical excision procedure, LEEP)
3. Concurrent cervical or intrauterine procedure (ie colposcopy or dilation and curettage)
4. Cutaneous damage at the TENS electrode sites
5. Chronic or pre-procedure use of opioids
6. Chronic pain diagnosis
7. Prior IUD insertion
8. Any contraindication to intrauterine device (IUD):

   1. Pregnancy
   2. Uterine anomaly that distorts the uterine cavity
   3. Acute pelvic inflammatory disease (PID)
   4. Postpartum endometritis or infected abortion in the past 3 months
   5. Unexplained abnormal uterine bleeding
   6. Wilson's disease or copper allergy (contraindication to copper IUD only)
   7. Breast cancer (contraindication to levonorgestrel IUD only

Where it's running

• Tufts Medical Center
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Andrea Zuckerman, MD — Tufts Medical Center
• Study coordinator: Caitie McCarthy, MD
• Email: caitlin.mccarthy@tuftsmedicine.org
• Phone: 617-636-9897

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.