Non-pharmacological Analgesic Effects on Term Newborns

Not Applicable

Completed

• Conditions: Breast Feeding; Pain
• Interventions: Behavioral: Skin-to-Skin contact; Behavioral: breastfeeding; Behavioral: Non-nutritive sucking; Dietary Supplement: oral sucrose

• Registration Number: NCT03421158
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2014-11-07
• Primary Completion: 2015-09-30
• Study Completion: 2017-08-31
• Status Verified: 2017-12
• Study First Submitted: 2018-01-29
• Study First Submitted QC: 2018-01-29
• Last Update Submitted: 2018-01-29
• Study First Posted: 2018-02-05
• Last Update Posted: 2018-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Skin to skin contact	Skin-to-Skin contact	Newborns were placed in direct contact with their mothers during the procedure
Breastfeeding	breastfeeding	Newborns were breastfed during the procedure
Non-nutritive sucking	Non-nutritive sucking	Newborns were given a pacifier to suck on during the procedure
Oral Sucrose	oral sucrose	Newborns were given oral sucrose during the procedure

Primary Outcome Measures

Name	Time	Method
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.