Non-Pharmacological Methods to Ease Heel Lances in Newborns
Official title: Comparison of the Effects of Foot Bath, ShotBlocker®, and Buzzy® on Neonatal Vital Signs During Heel Lance
Run by Atlas University · NCT07348731 · Data updated 2026-11-12
This study tests whether a warm foot bath, ShotBlocker®, or Buzzy® applied before a heel lance can help stabilize vital signs in term newborns.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 4 Days to 1 Month |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Atlas University Academic / other |
| Locations | 1 site (Istanbul, Kağıthane) |
| Status | Recruiting |
| Started | February 25, 2026 |
| Main results expected | February 25, 2026 |
| Study ends | June 15, 2026 |
| Registry record updated | June 2, 2026 |
| Trial ID | NCT07348731 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Term newborns (≥37 weeks gestation), 0–28 days old, with stable vitals and parental consent, undergoing a first-time heel lance.
✕Probably not a fit
Newborns with respiratory problems, prematurity (<37 weeks), low birth weight (<2500 g), or those already on analgesics/sedatives may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this randomized trial, term newborns undergoing a first heel lance are assigned to one of three non-drug interventions: warm foot bath, ShotBlocker®, or Buzzy®. The study records heart rate, respiratory rate, and oxygen saturation before, during, and after the procedure, along with pain scores and other neonatal data. Pain is assessed with the Neonatal Infant Pain Scale (NIPS), and video recordings are analyzed for pain indicators. Data will be analyzed with SPSS to compare the effects of the interventions on vital parameters and pain levels. The study aims to identify safe, feasible non-pharmacological pain-management options for neonatal care.
Why it matters
Potential benefit: If successful, these methods could reduce procedure-related stress in newborns and help maintain more stable vital signs during heel lance.
How similar studies have gone: Previous work has explored non-pharmacological approaches, with some showing reductions in distress markers, but results vary by method and population.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newborns with a gestational age of ≥37 weeks * Newborns in the neonatal period (0-28 days) * Stable vital signs * Obtained informed consent from the parents * No use of analgesics or sedatives within the 24 hours before the procedure * Absence of any respiratory problems * First-time heel lance procedure * No condition that would interfere with pain assessment Exclusion Criteria: * Preterm or low birth weight infants (\< 2500 g) * Infants with congenital anomalies or requiring respiratory support * Infants receiving sedative or analgesic treatment
Where it's running
-
Atlas University
Istanbul, Kağıthane, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: sermin dinç, Dr. — Atlas University
- Study coordinator: Sermin Dinc, Dr.
- Email: sermin.dinc@atlas.edu.tr
- Phone: 5424033430
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.