Non-Pharmacological Methods in Heel Lance

Condition(s) studied

Investigational drug(s) / intervention(s)

Foot bath: The infant's foot designated for blood sampling will be immersed up to the mid-calf level in water adjusted to 37-38°C, using a thermometer for confirmation, and kept there for 5 minutes. The heel lance procedure will then be performed by the nurse working in the clinic, following the standard clinical routine. The video recording will be stopped once bleeding has ceased at the end of the procedure. The video recordings obtained before, during, and after the procedure will be reviewed, and the infant's pain scores will be assessed by two independent experts.

Study summary

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

Primary outcome measure(s)

• Neonatal Infant Pain Scale — 0 minutes (T0)
  Min. 0-Max. 7 points (0-2 = mild to no pain, 3-4 = mild to moderate pain, \>4 = severe pain) moderate pain, \>4 = severe pain)
• Neonatal Infant Pain Scale — 5th minutes 1st (T1)
  Min. 0-Max. 7 points (0-2 = mild to no pain, 3-4 = mild to moderate pain, \>4 = severe pain)
• Neonatal Infant Pain Scale — 10th minutes (T2)
  Min. 0-Max. 7 points (0-2 = mild to no pain, 3-4 = mild to moderate pain, \>4 = severe pain)
• Heart Rate — 0 min (T0)
  beats/min.
• Heart Rate — 5th min 1st (T1)
  beats/min.
• Heart Rate — 10th minutes (T2)
  beats/min.
• Respiratory rate — 0 min (T0)
  respiration/minute
• Respiratory rate — 5th min 1st (T1)
  respiration/minute
• Respiratory rate — 10th minutes (T2)
  respiration/minute
• Saturation level — 0 min (T0)
  %100
• Saturation level — 5th min 1st (T1)
  %100
• Saturation level — 10th minutes (T2)
  %100

Trial sites (1)

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