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

Not Applicable

Completed

• Conditions: Abortion in First Trimester
• Interventions: Device: high frequency TENS treatment; Device: Sham TENS treatment

• 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

Study Timeline

• Study First Submitted: 2019-04-19
• Study First Submitted QC: 2019-04-19
• Study First Posted: 2019-04-24
• Study Start: 2019-06-11
• Primary Completion: 2020-03-06
• Study Completion: 2020-03-13
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-21
• Last Update Posted: 2021-04-22

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

Arm && Interventions

Group	Intervention	Description
TENS	high frequency TENS treatment	-
Sham TENS	Sham TENS treatment	-

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.

Trial Locations

Locations (1)

Planned Parenthood of New York City - Margaret Sanger Center; 🇺🇸 New York, New York, United States