NCT04851353

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2018

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 20, 2021

Completed
Last Updated

April 20, 2021

Status Verified

April 1, 2021

Enrollment Period

5 months

First QC Date

April 12, 2021

Last Update Submit

April 15, 2021

Conditions

Infant BehaviorPain, AcutePhysiological StressBreast Milk

Outcome Measures

Primary Outcomes (1)

  • Infants' pain reponse

    Neonatal Infant Pain Scale

    Six months

Secondary Outcomes (1)

  • The distress events of physiological parameters

    Six months

Study Arms (3)

GT+VC

ACTIVE COMPARATOR

Gentle touch +Verbal comfort

Behavioral: GT+VC

GT+VC+Smell

EXPERIMENTAL

Gentle touch +Verbal comfort+ Smell breast milk

Behavioral: GT+VCBehavioral: Smell

GT+VC+Smell+Taste

EXPERIMENTAL

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

Behavioral: GT+VCBehavioral: SmellBehavioral: Taste

Interventions

GT+VCBEHAVIORAL

Gentle touch and verbal comfort,

GT+VCGT+VC+SmellGT+VC+Smell+Taste
SmellBEHAVIORAL

Smell breast milk

GT+VC+SmellGT+VC+Smell+Taste
TasteBEHAVIORAL

Taste breast milk

GT+VC+Smell+Taste

Eligibility Criteria

Age2 Days - 1 Week
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Gestational age \> 36 weeks, birth weight \> 2200 g, and at least one parent agreed to participate.

You may not qualify if:

  • had congenital anomalies and neurologic impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National defense medical center

Taipei, Taiwan

Location

MeSH Terms

Conditions

Infant BehaviorAcute Pain

Interventions

SmellTaste

Condition Hierarchy (Ancestors)

Child BehaviorBehaviorPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SensationNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

April 12, 2021

First Posted

April 20, 2021

Study Start

September 26, 2017

Primary Completion

February 28, 2018

Study Completion

September 25, 2018

Last Updated

April 20, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)