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

NCT01800318 NA COMPLETED Results posted

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.

Details

Lead sponsor	University of Arkansas
Phase	NA
Status	COMPLETED
Enrolment	162
Start date	2013-03
Completion	2015-02

Conditions

• Pain

Interventions

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

Primary outcomes

• Changes From Baseline Premature Infant Pain Profile (PIPP) Score to Average PIPP Score During Heel Stick and Squeeze. — Baseline and first two minutes of heel stick an squeeze. PIPP scores are given every 30 seconds for the first two minutes of the heel stick and squeeze and then averaged..
  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. Physiologic portion of PIPP score: Oxygen saturation levels and heart rates are recorded at baseline and then continuously throughout initiation of the TENS unit and the heel stick procedure. Contextual score - gestational age + sleep/wake state. Subscale scores are added for a total PIPP score. Total or composite PIPP scores are reported. Scores on the PIPP for full term infants range from 0-18, with 0 being no pain, 1-6 minimal pain, 7-12 moderate pain, 13-18 severe pain.

Countries

United States