Non-pharmacological Analgesic Effects on Term Newborns

January 29, 2018 updated by: Annette Nasr, Stanford University

Comparing the Analgesic Effects of Four Non-pharmacological Interventions on Term Newborns Undergoing Heel Lance

The purpose of this study is to compare the analgesic effects of four non-pharmacological interventions: skin-to-skin contact, breastfeeding, oral sucrose and nonnutritive sucking in newborns receiving a heel lance procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an randomized control clinical study. study population is healthy term newborns.Patients were identified by chart review and consent was received by nurse researcher. Newborns were randomized into either the control group who received no pain intervention or the intervention group who received one of four non-pharmacological pain interventions: skin to skin contact, breastfeeding, oral sucrose, and nonnutritive sucking.

A heel lance for newborn screen blood sampling was selected as a study procedure and performed by a hospital technician following standard protocol. Pain scoring was assessed by two research nurses after the hell lance and through the procedure. Neonatal Pain, Agitation and Sedation Scale (NPASS) was selected as a pain assessment tool for this study.

The average pain score from two research nurses were used for statistical analysis.

Study Type

Interventional

Enrollment (Actual)

236

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 2 days (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Gestational Age 38-40
  • 2.5-4.0kg
  • 24-48hours of age
  • Receiving heel lance procedure
  • Apgar>7 at birth
  • NPASS<3 at time of heel lance

Exclusion Criteria:

  • Prior heel lance procedure
  • birth trauma
  • forceps or vacuum delivery
  • maternal drug abuse during delivery

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
Newborns received no pain interventions during the procedure
EXPERIMENTAL: Breastfeeding
Newborns were breastfed during the procedure
Behavioral: breastfeeding
Newborns were breastfed during the procedure
EXPERIMENTAL: Oral Sucrose
Newborns were given oral sucrose during the procedure
Dietary supplement: oral sucrose
Newborns were given oral sucrose during the procedure
EXPERIMENTAL: Skin to skin contact
Newborns were placed in direct contact with their mothers during the procedure
Behavioral: Skin-to-Skin contact
Newborns were placed in direct contact with their mothers during the procedure
EXPERIMENTAL: Non-nutritive sucking
Newborns were given a pacifier to suck on during the procedure
Behavioral: Non-nutritive sucking
newborns were given a pacifier to suck on during the procedure
Other Names:
  • Pacifier

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease in Neonatal Pain, Agitation and Sedation Scale (NPASS) scores for newborns receiving non-pharmacologic interventions
Time Frame: 12 month
Neonatal Pain, Agitation and Sedation Scale (NPASS) measures both behavioral and physiological components of pain by evaluating five key elements, and scores pain from 0-10 (Patricia A. Hummel, 2004). The assessment criteria are crying irritability, behavior state, facial expression, extremities tone, and vital signs.
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Jie Chang, BSN,MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 7, 2014

Primary Completion (ACTUAL)

September 30, 2015

Study Completion (ACTUAL)

August 31, 2017

Study Registration Dates

First Submitted

January 29, 2018

First Submitted That Met QC Criteria

January 29, 2018

First Posted (ACTUAL)

February 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2018

Last Update Submitted That Met QC Criteria

January 29, 2018

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 31216

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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