Non-pharmacological Analgesic Effects on Term Newborns

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03421158

Enrollment

236

Registered

2018-02-05

Start date

2014-11-07

Completion date

2017-08-31

Last updated

2018-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Breast Feeding

Keywords

neonates, Non-pharmacological

Brief summary

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.

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.

Interventions

BEHAVIORALbreastfeeding

Newborns were breastfed during the procedure

DIETARY_SUPPLEMENToral sucrose

Newborns were given oral sucrose during the procedure

BEHAVIORALSkin-to-Skin contact

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

BEHAVIORALNon-nutritive sucking

newborns were given a pacifier to suck on during the procedure

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

24 Hours to 48 Hours

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Decrease in Neonatal Pain, Agitation and Sedation Scale (NPASS) scores for newborns receiving non-pharmacologic interventions	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026