NCT03421158

Non-pharmacological Analgesic Effects on Term Newborns

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 236 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 24 Hours – 48 Hours
• Healthy volunteers: Accepted

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.

Conditions

• Pain
• Breast Feeding

Interventions

Type	Name	Description
BEHAVIORAL	breastfeeding	Newborns were breastfed during the procedure
DIETARY_SUPPLEMENT	oral sucrose	Newborns were given oral sucrose during the procedure
BEHAVIORAL	Skin-to-Skin contact	Newborns were placed in direct contact with their mothers during the procedure
BEHAVIORAL	Non-nutritive sucking	newborns were given a pacifier to suck on during the procedure

Timeline

• Start date: 2014-11-07
• Primary completion: 2015-09-30
• Completion: 2017-08-31
• First posted: 2018-02-05
• Last updated: 2018-02-05