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

National Defense Medical Center, Taiwan

Status: Completed

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

Treatments: Behavioral: Taste; Behavioral: GT+VC; Behavioral: Smell

Study type: Interventional

Funder types: Other

Identifiers

NCT04851353

1-106-05-136

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 2 days to 1 week old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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250 participants in 3 patient groups

GT+VC

Active Comparator group

Description:

Gentle touch +Verbal comfort

Treatment:

Behavioral: GT+VC

GT+VC+Smell

Experimental group

Description:

Gentle touch +Verbal comfort+ Smell breast milk

Treatment:

Behavioral: Smell

Behavioral: GT+VC

GT+VC+Smell+Taste

Experimental group

Description:

Gentle touch +Verbal comfort+ Smell breast milk+ Taste milk

Treatment:

Behavioral: Taste

Behavioral: Smell

Behavioral: GT+VC