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

Primary Purpose

Infant Behavior, Pain, Acute, Physiological Stress

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
GT+VC
Smell
Taste
Sponsored by
National Defense Medical Center, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infant Behavior

Eligibility Criteria

2 Days - 1 Week (Child)All SexesAccepts 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

Sites / Locations

  • National defense medical center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

GT+VC

GT+VC+Smell

GT+VC+Smell+Taste

Arm Description

Gentle touch +Verbal comfort

Gentle touch +Verbal comfort+ Smell breast milk

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

Outcomes

Primary Outcome Measures

Infants' pain reponse
Neonatal Infant Pain Scale

Secondary Outcome Measures

The distress events of physiological parameters
Heart rate, oxygen saturation, and crying event

Full Information

First Posted
April 12, 2021
Last Updated
April 15, 2021
Sponsor
National Defense Medical Center, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT04851353
Brief Title
Multiple Sensory Interventions On Infants' Pain and Physiological Distress During Neonatal Screening Procedures
Acronym
MSI
Official Title
Breast Milk as Multiple Sensory Interventions On Infants' Pain and Physiological Distress During Neonatal Screening Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 26, 2017 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
September 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Defense Medical Center, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant Behavior, Pain, Acute, Physiological Stress, Breast Milk

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GT+VC
Arm Type
Active Comparator
Arm Description
Gentle touch +Verbal comfort
Arm Title
GT+VC+Smell
Arm Type
Experimental
Arm Description
Gentle touch +Verbal comfort+ Smell breast milk
Arm Title
GT+VC+Smell+Taste
Arm Type
Experimental
Arm Description
Gentle touch +Verbal comfort+ Smell breast milk+ Taste milk
Intervention Type
Behavioral
Intervention Name(s)
GT+VC
Intervention Description
Gentle touch and verbal comfort,
Intervention Type
Behavioral
Intervention Name(s)
Smell
Intervention Description
Smell breast milk
Intervention Type
Behavioral
Intervention Name(s)
Taste
Intervention Description
Taste breast milk
Primary Outcome Measure Information:
Title
Infants' pain reponse
Description
Neonatal Infant Pain Scale
Time Frame
Six months
Secondary Outcome Measure Information:
Title
The distress events of physiological parameters
Description
Heart rate, oxygen saturation, and crying event
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Days
Maximum Age & Unit of Time
1 Week
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
National defense medical center
City
Taipei city
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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