Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management With Medication Abortion Through 70 Days' Gestation

Planned Parenthood of Greater New York

Status: Completed

Conditions: Abortion in First Trimester

Treatments: Device: high frequency TENS treatment; Device: Sham TENS treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03925129

TENS MAB

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

---

40 participants in 2 patient groups

TENS

Experimental group

Treatment:

Device: high frequency TENS treatment

Sham TENS

Sham Comparator group

Treatment:

Device: Sham TENS treatment