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Completed

NCT Number: NCT04851353

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

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.

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Key information

Conditions

Infant Behavior Acute Pain Behavior Breast Milk Child Behavior Neurologic Manifestations Pain Pain, Acute Pathological Conditions, Signs and Symptoms Physiological Stress Signs and Symptoms

Age range

2 day–1 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National defense medical center

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GT+VC

Behavioral

Gentle touch and verbal comfort,

Smell

Behavioral

Smell breast milk

Taste

Behavioral

Taste breast milk

Primary outcomes

  1. Infants' pain reponse

    Time frame: Six months

    Neonatal Infant Pain Scale

Secondary outcomes

  1. The distress events of physiological parameters

    Time frame: Six months

    Heart rate, oxygen saturation, and crying event

Sponsors and collaborators

Lead sponsor

National Defense Medical Center, Taiwan

Other

Registry information

Official study title

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

Acronym: MSI

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 20, 2021
Registry last updated
Apr 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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