RecruitingNot ApplicableNCT07348731

Non-Pharmacological Methods in Heel Lance

Comparison of the Effects of Foot Bath, ShotBlocker®, and Buzzy® on Neonatal Vital Signs During Heel Lance


Sponsor

Atlas University

Enrollment

90 participants

Start Date

Feb 25, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 4 DaysMax Age: 1 Month

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Foot bath for people with heel lance procedures. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALFoot 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.


Locations(1)

Atlas University

Istanbul, Kağıthane, Turkey (Türkiye)

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NCT07348731