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