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Clinical Trials/NCT03925129
NCT03925129CompletedNot Applicable

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

Planned Parenthood of Greater New York2 sites in 1 country40 target enrollmentStarted: June 11, 2019Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
40
Locations
2
Primary Endpoint
Pain on numeric rating scale
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Planned Parenthood of Greater New York
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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