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

Not Applicable

Completed

• Conditions: Physiological Stress; Infant Behavior; Pain, Acute; Breast Milk
• Interventions: Behavioral: GT+VC; Behavioral: Smell; Behavioral: Taste

• Registration Number: NCT04851353
• Lead Sponsor: National Defense Medical Center, Taiwan

Brief 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.

Study Timeline

• Study Start: 2017-09-26
• Primary Completion: 2018-02-28
• Study Completion: 2018-09-25
• Status Verified: 2021-04
• Study First Submitted: 2021-04-12
• Study First Submitted QC: 2021-04-15
• Last Update Submitted: 2021-04-15
• Study First Posted: 2021-04-20
• Last Update Posted: 2021-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Gestational age > 36 weeks, birth weight > 2200 g, and at least one parent agreed to participate.

Exclusion Criteria

• had congenital anomalies and neurologic impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
GT+VC+Smell+Taste	Smell	Gentle touch +Verbal comfort+ Smell breast milk+ Taste milk
GT+VC+Smell+Taste	Taste	Gentle touch +Verbal comfort+ Smell breast milk+ Taste milk
GT+VC+Smell	GT+VC	Gentle touch +Verbal comfort+ Smell breast milk
GT+VC	GT+VC	Gentle touch +Verbal comfort
GT+VC+Smell	Smell	Gentle touch +Verbal comfort+ Smell breast milk
GT+VC+Smell+Taste	GT+VC	Gentle touch +Verbal comfort+ Smell breast milk+ Taste milk

Primary Outcome Measures

Name	Time	Method
Infants' pain reponse	Six months	Neonatal Infant Pain Scale

Secondary Outcome Measures

Name	Time	Method
The distress events of physiological parameters	Six months	Heart rate, oxygen saturation, and crying event

Trial Locations

Locations (1)

National defense medical center; 🇨🇳 Taipei city, Taiwan