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

April 15, 2021 updated by: Hsiang-Yun Lan, National Defense Medical Center, Taiwan

Breast Milk as 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei city, Taiwan
        • National defense medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 days to 1 week (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: GT+VC
Gentle touch +Verbal comfort
Behavioral: GT+VC
Gentle touch and verbal comfort,
EXPERIMENTAL: GT+VC+Smell
Gentle touch +Verbal comfort+ Smell breast milk
Behavioral: GT+VC
Gentle touch and verbal comfort,
Behavioral: Smell
Smell breast milk
EXPERIMENTAL: GT+VC+Smell+Taste
Gentle touch +Verbal comfort+ Smell breast milk+ Taste milk
Behavioral: GT+VC
Gentle touch and verbal comfort,
Behavioral: Smell
Smell breast milk
Behavioral: Taste
Taste breast milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infants' pain reponse
Time Frame: Six months
Neonatal Infant Pain Scale
Six months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Defense Medical Center, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 26, 2017

Primary Completion (ACTUAL)

February 28, 2018

Study Completion (ACTUAL)

September 25, 2018

Study Registration Dates

First Submitted

April 12, 2021

First Submitted That Met QC Criteria

April 15, 2021

First Posted (ACTUAL)

April 20, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 20, 2021

Last Update Submitted That Met QC Criteria

April 15, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-106-05-136

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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