Non-pharmacological Analgesic Effects on Term Newborns
Comparing the Analgesic Effects of Four Non-pharmacological Interventions on Term Newborns Undergoing Heel Lance
1 other identifier
interventional
236
0 countries
N/A
Brief Summary
The purpose of this study is to compare the analgesic effects of four non-pharmacological interventions: skin-to-skin contact, breastfeeding, oral sucrose and nonnutritive sucking in newborns receiving a heel lance procedure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started Nov 2014
Longer than P75 for not_applicable pain
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2017
CompletedFirst Submitted
Initial submission to the registry
January 29, 2018
CompletedFirst Posted
Study publicly available on registry
February 5, 2018
CompletedFebruary 5, 2018
December 1, 2017
11 months
January 29, 2018
January 29, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Decrease in Neonatal Pain, Agitation and Sedation Scale (NPASS) scores for newborns receiving non-pharmacologic interventions
Neonatal Pain, Agitation and Sedation Scale (NPASS) measures both behavioral and physiological components of pain by evaluating five key elements, and scores pain from 0-10 (Patricia A. Hummel, 2004). The assessment criteria are crying irritability, behavior state, facial expression, extremities tone, and vital signs.
12 month
Study Arms (5)
Control
NO INTERVENTIONNewborns received no pain interventions during the procedure
Breastfeeding
EXPERIMENTALNewborns were breastfed during the procedure
Oral Sucrose
EXPERIMENTALNewborns were given oral sucrose during the procedure
Skin to skin contact
EXPERIMENTALNewborns were placed in direct contact with their mothers during the procedure
Non-nutritive sucking
EXPERIMENTALNewborns were given a pacifier to suck on during the procedure
Interventions
Newborns were placed in direct contact with their mothers during the procedure
newborns were given a pacifier to suck on during the procedure
Eligibility Criteria
You may qualify if:
- Gestational Age 38-40
- hours of age
- Receiving heel lance procedure
- Apgar\>7 at birth
- NPASS\<3 at time of heel lance
You may not qualify if:
- Prior heel lance procedure
- birth trauma
- forceps or vacuum delivery
- maternal drug abuse during delivery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jie Chang, BSN,MD
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor, Pediatrics
Study Record Dates
First Submitted
January 29, 2018
First Posted
February 5, 2018
Study Start
November 7, 2014
Primary Completion
September 30, 2015
Study Completion
August 31, 2017
Last Updated
February 5, 2018
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will share