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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04851353

Acronym

MSI

Enrollment

250

Registered

2021-04-20

Start date

2017-09-26

Completion date

2018-09-25

Last updated

2021-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BEHAVIORALGT+VC

Gentle touch and verbal comfort,

BEHAVIORALSmell

Smell breast milk

BEHAVIORALTaste

Taste breast milk

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

2 Days to 1 Weeks

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Infants' pain reponse	Six months	Neonatal Infant Pain Scale

Secondary

Measure	Time frame	Description
The distress events of physiological parameters	Six months	Heart rate, oxygen saturation, and crying event

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026