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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GT+VC | Active Comparator | Gentle touch +Verbal comfort |
|
| GT+VC+Smell | Experimental | Gentle touch +Verbal comfort+ Smell breast milk |
|
| GT+VC+Smell+Taste | Experimental | Gentle touch +Verbal comfort+ Smell breast milk+ Taste milk |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GT+VC | Behavioral | Gentle touch and verbal comfort, |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infants' pain reponse | Neonatal Infant Pain Scale | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| The distress events of physiological parameters | Heart rate, oxygen saturation, and crying event | Six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National defense medical center | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D018730 | Infant Behavior |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D002652 | Child Behavior |
| D001519 | Behavior |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D012903 | Smell |
| D013649 | Taste |
| ID | Term |
|---|---|
| D012677 | Sensation |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Smell | Behavioral | Smell breast milk |
|
| Taste | Behavioral | Taste breast milk |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |