CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 109 enrolled
Drug / intervention
Moderate IV Sedation +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03187002
NCT03187002N/ACompleted
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Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Control During First Trimester Abortion: A Blinded Randomized Controlled Trial

Stanford University·interventional·Posted Jun 14, 2017·Updated Nov 2, 2020

In Brief

A clinical study evaluating Transcutaneous electrical nerve stimulation (TENS), Moderate IV Sedation, and 2 other interventions for Abortion in First Trimester. Completed, enrolled 109 participants across 1 site.

Detailed Summary

High-frequency, high-intensity transcutaneous electrical nerve-stimulation (TENS) is an inexpensive and non-invasive pain control approach. TENS, pulsating electrical currents that activate underlying nerves, does not have drug interactions or risk of overdose. Cochrane review of TENS for acute pain found inconclusive evidence. One previous abortion trial comparing TENS to IV sedation only looked at pain control in the recovery room. The investigators propose a randomized controlled trial comparing TENS to IV sedation (in conjunction with local anesthesia) among women presenting for first-trimester surgical abortion. Primary outcome will be perceived pain by Visual Analogue Scale (VAS) during aspiration.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAbortion in First Trimester
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJun 14, 2017
Enrollment StartJan 18, 2018
Primary CompletionOct 31, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 9.0 years ago

Interventions

Transcutaneous electrical nerve stimulation (TENS)device

Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders.

Moderate IV Sedationdrug

IV sedation with fentanyl and versed

SHAM: Transcutaneous electrical nerve stimulation (TENS)other

Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding

SHAM: Moderate IV Sedationother

Sham IV to ensure blinding