Non-Pharmacological Methods in Heel Lance

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-1
SponsorAtlas University

About this trial

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 assessment. Additionally, the infant's crying duration and time to bleeding cessation will also be evaluated.

Eligibility criteria

Qualifiers

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

Disqualifiers

Preterm or low birth weight infants (< 2500 g)

Infants with congenital anomalies or requiring respiratory support

Infants receiving sedative or analgesic treatment

Trial design

Treatments tested in this trial

  • Foot bath

Treatment groups

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators