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Clinical Trial Summary

The study purposes are to compare the effects of different combinations of sensory interventions on newborns' pain responses, physiological distress (heart rate and oxygen saturation), and crying event during heel stick procedures.


Clinical Trial Description

Newborns undergo many necessary invasive procedures for routine care, but these treatments may cause stress and pain. The study purposes are to compare the effects of different combinations of sensory interventions on newborns' pain responses, physiological distress (heart rate and oxygen saturation), and crying event during heel stick procedures. This study was a prospective, randomized controlled trial. Infants were recruited by convenience sampling in a baby room of a medical center in northern Taiwan from September in 2017 to September in 2018. Newborns who met the criteria were recruited by blocked random to three treatment groups: (1)Gentle touch + Verbal comfort, (2) Smell + gentle touch + Verbal comfort, (3) Smell + Taste + Touch + Verbal comfort. Pain response was measured by the Neonatal Infant Pain Scale (NIPS). The physical distress events were measured by the abnormal heart rate and oxygen saturation event, and crying event. All data were collected 5 minutes before heel-stick (baseline), during heel-stick and in recovery status. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04851353
Study type Interventional
Source National Defense Medical Center, Taiwan
Contact
Status Completed
Phase N/A
Start date September 26, 2017
Completion date September 25, 2018

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