Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management With Medication Abortion Through 70 Days' Gestation
Not Applicable
Completed
- Conditions
- Abortion in First Trimester
- Registration Number
- NCT03925129
- Lead Sponsor
- Planned Parenthood of Greater New York
- Brief Summary
This is a double-blinded, randomized, placebo-controlled trial evaluating the use of High-frequency Transcutaneous Electrical Nerve Stimulation (HfTENS) compared to sham TENS for pain control during medication abortion with mifepristone and misoprostol through 70 days' gestation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 40
Inclusion Criteria
- Patients seeking medication abortion with a definite, singleton, intrauterine pregnancy (IUP) < 70 days' gestation on ultrasound
- Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF)22 score > 4
- Age equal to or greater than 18 years
- Provide informed consent to participate
- Willing to adhere to study procedures, including access to a smart phone, ability to receive text messages and answer online surveys on smart phone
Exclusion Criteria
- Contraindication to medication abortion
- Allergy to mifepristone or misoprostol
- Contraindication or allergy to ibuprofen
- History of cardiac arrhythmia
- Presence of an implantable device with electrical discharge, i.e. cardiac pacemaker
- History of chronic pain disorder
- Any opioid use during previous 30 days
- Current or prior use of TENS
- BMI > 30
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Pain on numeric rating scale 8 hours following misoprostol Maximum pain score on an 11-point numeric rating scale, where 0 is no pain, and 10 is the worst pain.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Planned Parenthood of New York City - Margaret Sanger Center
🇺🇸New York, New York, United States
Planned Parenthood of New York City - Margaret Sanger Center🇺🇸New York, New York, United States