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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Neonatal Infant Pain Scale
Timeframe: 0 minutes (T0)
Neonatal Infant Pain Scale
Timeframe: 5th minutes 1st (T1)
Neonatal Infant Pain Scale
Timeframe: 10th minutes (T2)
Heart Rate
Timeframe: 0 min (T0)
Heart Rate
Timeframe: 5th min 1st (T1)
Heart Rate
Timeframe: 10th minutes (T2)
Respiratory rate
Timeframe: 0 min (T0)
Respiratory rate
Timeframe: 5th min 1st (T1)
Respiratory rate
Timeframe: 10th minutes (T2)
Saturation level
Timeframe: 0 min (T0)
Saturation level
Timeframe: 5th min 1st (T1)
Saturation level
Timeframe: 10th minutes (T2)