Completed

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

What is being tested

24% oral Sucrose

+ Sham NESAP

+ NESAP

BehavioralDevice

Who is being recruted

Neurologic Manifestations+1

+ Signs and Symptoms

+ Pathological Conditions, Signs and Symptoms

+21 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled

Interventional

Study Start: March 2013

See protocol details

Summary

Principal SponsorUniversity of Arkansas

Last updated: January 16, 2017

Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

A collaborative prospective, double-blind, randomized trial will be performed at the University of Arkansas for Medical Sciences Hospital (Little Rock, AR), and Lucille Packard Children's Hospital (Palo Alto, CA). After obtaining IRB approval at both sites and parental consent, newborn infants less than 3 days of age who require heelsticks for clinical blood sampling will be randomized in a 2 × 2 factorial trial design to four groups: standard pain management with pacifier and water, Non-invasive Electrical Stimulation of Acupuncture Points (NESAP) with pacifier and water, 24% oral sucrose solution with pacifier, or NESAP plus oral sucrose solution and pacifier prior to their heelstick. We will study the pain response to the heelstick routinely used to obtain blood for term neonatal infants by enrolling up to 192 infants, 96 from University of Arkansas for Medical Sciences and 96 from Lucille Packard Children's Hospital. This number will allow for screen failures and withdrawals. A minimum of 164 infants collectively from both sites is required to complete the study. Infants will be divided into 4 experimental groups: Group A: Sham (fake electrical stimulation) plus sugar water with pacifier before heelstick. Group B: Electrical stimulation plus water with pacifier before heelstick. Group C: Electrical stimulation plus sugar water with pacifier before heelstick. Group D: Sham (fake electrical stimulation) plus water with pacifier before heelstick. Electrical stimulation will be applied at appropriate acupuncture points using a very low current for 10 minutes, routine for procedural pain. The response to pain will be assessed using a pain scale, heart rate, heart rate variability and oxygen saturation changes, duration of crying, and changes in salivary cortisol levels.

NCT01800318

Principal SponsorUniversity of Arkansas

Last updated: January 16, 2017

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

162 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPain

Criteria

4 inclusion criteria required to participate

Less than 3 days of age

Newborn infants born at 37-42 weeks gestational age

Requiring a heelstick for clinically indicated blood sampling

Written, informed consent from their parents

17 exclusion criteria prevent from participating

Abnormal neurological exam

Any condition the investigator determines will put the subject at risk if participating in the study

Bleeding abnormality

Congenital heart defects

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit. Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.

Group II

Experimental

NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on with settings 3.5mA, 10 Hz. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit. Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given

Group III

Experimental

NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick at settings 3.5 mA, 10 Hz. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit. Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.

Group IV

Placebo

Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit. Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

University of Arkansas for Medical Sciences

Little Rock, United StatesOpen University of Arkansas for Medical Sciences in Google Maps

Stanford University

Stanford, United States

Completed2 Study Centers