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NCT04851353 Clinical Trial

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

Pain, Acute Clinical Trial

— MSI  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04851353
Other study ID # 1-106-05-136
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 26, 2017
Est. completion date September 25, 2018

Study information
Verified date April 2021
Source National Defense Medical Center, Taiwan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 250
Est. completion date September 25, 2018
Est. primary completion date February 28, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 1 Week
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• GT+VC
Gentle touch and verbal comfort,
• Smell
Smell breast milk
• Taste
Taste breast milk

Locations
Country Name City State
Taiwan National defense medical center Taipei city

Sponsors (1)
Lead Sponsor Collaborator
National Defense Medical Center, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Infants' pain reponse Neonatal Infant Pain Scale Six months
Secondary The distress events of physiological parameters Heart rate, oxygen saturation, and crying event Six months
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