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

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.

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Key information

Conditions

Abortion in First Trimester

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Planned Parenthood of New York City - Margaret Sanger Center

New York, 10012, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

high frequency TENS treatment

Device

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

Sham TENS treatment

Device

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

Primary outcomes

Pain on numeric rating scale

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Planned Parenthood of Greater New York

Other

Registry information

Official study title

A Randomized, Placebo Controlled Trial of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management With Medication Abortion Through 70 Days' Gestation

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Apr 24, 2019
Registry last updated: Apr 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed