Phase
Condition
Intrauterine Device
Pain
Acute Pain
Treatment
Standard care
TENS (transcutaneous electrical nerve stimulation) unit
Clinical Study ID
Ages 12-50 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Persons with a uterus desiring insertion of intrauterine device
Able to provide informed consent/assent
Age 12-50 years old
Minors 12 years of age and older will be included in the study if postmenarchal
Exclusion
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 andcurettage)
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)
Postpartum endometritis or infected abortion in the past 3 months
Unexplained abnormal uterine bleeding
Wilson's disease or copper allergy (contraindication to copper IUD only)
Breast cancer (contraindication to levonorgestrel IUD only
Study Design
Connect with a study center
Tufts Medical Center
Boston, Massachusetts 02111
United StatesActive - Recruiting
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