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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: Completed NA study, sponsored by University of Arkansas.
NCT01800318 is a NA study that has completed, run by University of Arkansas. The registered enrollment target is 162 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The PIPP score includes assessment of contextual, physiological, and behavioral parameters and has been extensively validated for pain assessment in preterm and term infants. PIPP scores were given at baseline before initiation of the TENS unit,and every 30 seconds for the first two minutes of the heel stick and heel squeeze (4 times). The four PIPP scores given during heel stick and squeeze were averaged. Behavioral portion of PIPP score: facial expressions are videotaped and analyzed. Physiol
Interventions
- DEVICE NESAP
- BEHAVIORAL 24% oral Sucrose
- DEVICE Sham NESAP
- BEHAVIORAL Oral water
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 162 participants |
| Start Date | 2013-03 |
| Est. Completion | 2015-02 |
| Phase | NA |
What the finished NCT01800318 record still lists
NCT01800318 is an interventional study that assigns participants to a tested intervention. The registered 162 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 4 interventions - of which NESAP is the first listed.
NCT01800318 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01800318's enrollment target sits among peer trials
162 627th of 2000 higher than 1,373 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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