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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: GT+VC
* Behavioral: Smell
* Behavioral: Taste


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Days
Maximum Age: 1 Week

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GT+VC<br>Gentle touch +Verbal comfort | Behavioral: GT+VC<br>* Gentle touch and verbal comfort,<br>|
| Experimental: GT+VC+Smell<br>Gentle touch +Verbal comfort+ Smell breast milk | Behavioral: GT+VC<br>* Gentle touch and verbal comfort,<br>Behavioral: Smell<br>* Smell breast milk<br>|
| Experimental: GT+VC+Smell+Taste<br>Gentle touch +Verbal comfort+ Smell breast milk+ Taste milk | Behavioral: GT+VC<br>* Gentle touch and verbal comfort,<br>Behavioral: Smell<br>* Smell breast milk<br>Behavioral: Taste<br>* Taste breast milk<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infants' pain reponse | Neonatal Infant Pain Scale | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The distress events of physiological parameters | Heart rate, oxygen saturation, and crying event | Six months |