Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
236 participants
INTERVENTIONAL
2014-11-07
2017-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Two Methods of Analgesia for Chinese Term Infants Receiving Heel Lance
NCT01355640
Non-pharmacological Analgesia During Heel Prick
NCT01576432
Non-pharmacological Methods in Pain Managment During Heel Stick in Preterm Infants
NCT05281367
Pain Reactivity to Non-Pharmacological Interventions Across Repeated Routine Heel-Sticks in Preterm Infants in a Neonatal Intensive Care Unit
NCT00758511
Non-Nutritive Sucking and Swaddling for Pain Relief in Term Neonates: Randomised Controlled Trial
NCT00547807
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
A heel lance for newborn screen blood sampling was selected as a study procedure and performed by a hospital technician following standard protocol. Pain scoring was assessed by two research nurses after the hell lance and through the procedure. Neonatal Pain, Agitation and Sedation Scale (NPASS) was selected as a pain assessment tool for this study.
The average pain score from two research nurses were used for statistical analysis.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control
Newborns received no pain interventions during the procedure
No interventions assigned to this group
Breastfeeding
Newborns were breastfed during the procedure
breastfeeding
Newborns were breastfed during the procedure
Oral Sucrose
Newborns were given oral sucrose during the procedure
oral sucrose
Newborns were given oral sucrose during the procedure
Skin to skin contact
Newborns were placed in direct contact with their mothers during the procedure
Skin-to-Skin contact
Newborns were placed in direct contact with their mothers during the procedure
Non-nutritive sucking
Newborns were given a pacifier to suck on during the procedure
Non-nutritive sucking
newborns were given a pacifier to suck on during the procedure
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
breastfeeding
Newborns were breastfed during the procedure
oral sucrose
Newborns were given oral sucrose during the procedure
Skin-to-Skin contact
Newborns were placed in direct contact with their mothers during the procedure
Non-nutritive sucking
newborns were given a pacifier to suck on during the procedure
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 2.5-4.0kg
* 24-48hours of age
* Receiving heel lance procedure
* Apgar\>7 at birth
* NPASS\<3 at time of heel lance
Exclusion Criteria
* birth trauma
* forceps or vacuum delivery
* maternal drug abuse during delivery
24 Hours
48 Hours
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Stanford University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Annette Nasr
Clinical Assistant Professor, Pediatrics
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jie Chang, BSN,MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
31216
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.