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Non-Pharmacological Methods in Heel Lance

RecruitingNAAges 4 Days - 1 MonthAllAtlas University
NCT07348731 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This randomized controlled study was designed to compare the effects of Warm Foot Bath, ShotBlocker®, and Buzzy®-applied prior to heel lance-on the vital signs of newborns. Heel lance is one of the most frequently performed invasive procedures during the neonatal period, and the pain and stress experienced during the procedure may lead to alterations in vital parameters such as heart rate, respiratory rate, and oxygen saturation. Therefore, identifying non-pharmacological, safe, and feasible pain management methods is essential for enhancing the quality of nursing care. Data will be collected at three time points: before, during, and after the procedure, and changes in heart rate, respiratory rate, and SpO₂ will be recorded. With parental consent, the procedure will be video-recorded before, during, and after heel lance; the recordings will be anonymized and shared with experts for pain

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📋 Eligibility rules (as published)
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
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What it tests

  • Foot bath
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Where

1 site
Atlas University
Istanbul, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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