NCT04851353

Multiple Sensory Interventions On Infants' Pain and Physiological Distress During Neonatal Screening Procedures

Breast Milk as Multiple Sensory Interventions On Infants' Pain and Physiological Distress During Neonatal Screening Procedures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: National Defense Medical Center, Taiwan · Academic / Other
• Sex: All
• Age: 2 Days – 1 Week
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Infant Behavior
• Pain, Acute
• Physiological Stress
• Breast Milk

Interventions

Type	Name	Description
BEHAVIORAL	GT+VC	Gentle touch and verbal comfort,
BEHAVIORAL	Smell	Smell breast milk
BEHAVIORAL	Taste	Taste breast milk

Timeline

• Start date: 2017-09-26
• Primary completion: 2018-02-28
• Completion: 2018-09-25
• First posted: 2021-04-20
• Last updated: 2021-04-20

Locations

1 site across 1 country: Taiwan