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NCT03925129 Clinical Trial

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

Abortion in First Trimester Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03925129
Other study ID # TENS MAB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 11, 2019
Est. completion date March 13, 2020

Study information
Verified date April 2021
Source Planned Parenthood of Greater New York
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date March 13, 2020
Est. primary completion date March 6, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• high frequency TENS treatment
Treatment with high frequency for minimum of 1 hour after misoprostol administration
• Sham TENS treatment
Treatment with sham TENS device for minimum of 1 hour after misoprostol administration

Locations
Country Name City State
United States Planned Parenthood of New York City - Margaret Sanger Center New York New York

Sponsors (1)
Lead Sponsor Collaborator
Planned Parenthood of Greater New York

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 8 hours following misoprostol
See also
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Enrolling by invitation NCT05320432 - Transcutaneous Electrical Nerve Stimulation for Pain Control During First-trimester Abortion N/A
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Completed NCT02096575 - Nitrous Oxide for Pain Management of First Trimester Surgical Abortion N/A