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

NCT ID: NCT04851353

Last Updated: 2021-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-26

Study Completion Date

2018-09-25

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.

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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.

Conditions

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Infant Behavior Pain, Acute Physiological Stress Breast Milk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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GT+VC

Gentle touch +Verbal comfort

Group Type ACTIVE_COMPARATOR

GT+VC

Intervention Type BEHAVIORAL

Gentle touch and verbal comfort,

GT+VC+Smell

Gentle touch +Verbal comfort+ Smell breast milk

Group Type EXPERIMENTAL

GT+VC

Intervention Type BEHAVIORAL

Gentle touch and verbal comfort,

Smell

Intervention Type BEHAVIORAL

Smell breast milk

GT+VC+Smell+Taste

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

Group Type EXPERIMENTAL

GT+VC

Intervention Type BEHAVIORAL

Gentle touch and verbal comfort,

Smell

Intervention Type BEHAVIORAL

Smell breast milk

Taste

Intervention Type BEHAVIORAL

Taste breast milk

Interventions

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GT+VC

Gentle touch and verbal comfort,

Intervention Type BEHAVIORAL

Smell

Smell breast milk

Intervention Type BEHAVIORAL

Taste

Taste breast milk

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

2 Days

Maximum Eligible Age

1 Week

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Defense Medical Center, Taiwan

OTHER

Sponsor Role lead

Responsible Party

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Hsiang-Yun Lan

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National defense medical center

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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1-106-05-136

Identifier Type: -

Identifier Source: org_study_id

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