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

Planned Parenthood of Greater New York40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Abortion in First Trimester

Interventions

high frequency TENS treatmentDEVICE

Treatment with high frequency for minimum of 1 hour after misoprostol administration

Sham TENS treatmentDEVICE

Treatment with sham TENS device for minimum of 1 hour after misoprostol administration

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Planned Parenthood of New York City - Margaret Sanger Center

New York, New York, United States

Outcomes

Primary Outcomes

Pain on numeric rating scale

Maximum pain score on an 11-point numeric rating scale, where 0 is no pain, and 10 is the worst pain.

Time frame: 8 hours following misoprostol

Data from ClinicalTrials.gov

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