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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Abortion in First Trimester

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