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NCT01800318 · ClinicalTrials.gov registry record · NA

Does Noninvasive Electrical Stimulation of Acupuncture Points (NESAP) Reduce Heelstick Pain in Infants?

A NA study, sponsored by University of Arkansas.

Completed
Registry status
NA
Development phase
162
Enrollment target

NCT01800318 is a NA study that has completed, run by University of Arkansas. The registered enrollment target is 162 participants.

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The verdict

NCT01800318, a NA study, has completed, sponsored by University of Arkansas.

COMPLETED
Registry status
NA
Development phase
162 participants
Enrollment target

Study Summary

The purpose of the study is to determine whether noninvasive electrical stimulation at acupuncture points (NESAP) and/or 24% sucrose is effective in reducing pain in infants during invasive procedures. The investigators hypothesize that: * Gentle noninvasive electrical stimulation at selected acupuncture points and/or oral use of 24% sucrose with pacifier will reduce the newborn infant's responses to heelstick pain, as measured by the Premature Infant Pain Profile (PIPP), heart rate variability, duration of crying, and salivary cortisol levels. * The effects of combined therapies will be additive. * The analgesic effects of NESAP and/or sucrose will continue for the duration of the heelstick, reflected by the first two minutes of heelstick and the first two minutes of recovery.

Interventions

  • DEVICE NESAP
  • BEHAVIORAL 24% oral Sucrose
  • DEVICE Sham NESAP
  • BEHAVIORAL Oral water

Trial Details

FieldValue
Enrollment Target 162 participants
Start Date 2013-03
Est. Completion 2015-02
Phase NA

Sponsor

University of Arkansas

318 total trials

What the Registry Record Tells You About NCT01800318

The ClinicalTrials.gov registry entry for NCT01800318 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 162 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arkansas, which has 318 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which NESAP is the first listed.

NCT01800318 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01800318 about?

NCT01800318 is a clinical study titled "Does Noninvasive Electrical Stimulation of Acupuncture Points (NESAP) Reduce Heelstick Pain in Infants?". The purpose of the study is to determine whether noninvasive electrical stimulation at acupuncture points (NESAP) and/or 24% sucrose is effective in reducing pain in infants during invasive procedures. The investigators hypothesize that: * Gentle noninvasive electrical stimulation at selected acup...

What is the current status of trial NCT01800318?

This trial is currently completed. It is a NA study. The enrollment target is 162 participants. The study started on 2013-03. Estimated completion is 2015-02.

What interventions are being tested in trial NCT01800318?

The interventions under investigation include: NESAP (DEVICE), 24% oral Sucrose (BEHAVIORAL), Sham NESAP (DEVICE), Oral water (BEHAVIORAL).

Who is sponsoring clinical trial NCT01800318?

This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.