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Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Control During Cervical Dilator Placement Prior to Dilation and Evacuation

NCT03868787 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2023-07-25

Study results available
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Summary

This study evaluates the use of Transcutaneous Electrical Nerve Stimulation (TENS) as a method of pain control during osmotic dilator insertion prior to dilation and evacuation. Half the group will have an active TENS unit and half will have a sham or placebo TENS unit.

Conditions

  • Pain Management

Interventions

DEVICE

TENS

TENS units are small, inexpensive, portable, battery-powered devices which deliver mild, alternating electrical currents via electrodes positioned on the skin near the anticipated dermatomal distribution of pain.

DEVICE

Sham TENS

Non-active TENS unit

Sponsors & Collaborators

Principal Investigators

  • Leanne McCloskey, MD, MPH · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2020-11-01
Completion
2021-04-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03868787 on ClinicalTrials.gov