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OpenTrials
Completed

NCT Number: NCT03421158

Non-pharmacological Analgesic Effects on Term Newborns

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.

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Key information

Conditions

Pain Behavior Breast Feeding Feeding Behavior Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

24 hour–48 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

breastfeeding

Behavioral

Newborns were breastfed during the procedure

oral sucrose

Dietary Supplement

Newborns were given oral sucrose during the procedure

Skin-to-Skin contact

Behavioral

Newborns were placed in direct contact with their mothers during the procedure

Non-nutritive sucking

Behavioral

newborns were given a pacifier to suck on during the procedure

Other names: Pacifier

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Feb 5, 2018
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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