Study of Buzzy4 and Shotbloker4 to Reduce Pain and Improve Comfort in Full-Term Newborns During Heel Blood Sampling

What this Trial Is About

Researchers are evaluating the effects of two devices, Buzzy4 and Shotbloker4, on pain and comfort levels in newborns during heel prick blood sampling. This randomized controlled trial involves 159 full-term newborns admitted to a neonatal care unit between March and December 2025. The study uses specific pain and comfort scales to assess newborn responses to these interventions compared to routine care without any device application. The trial includes three groups one using the Buzzy4 device, which involves applying an ice pack and vibration to the heel before and after blood collection a second group using the Shotbloker4 device, which applies pressure with protrusions before puncturing the heel and a control group receiving standard care without intervention. Blood samples are collected from the left heel using sterile lancets, following a consistent procedure across all groups. During the study, newborns are held by their mothers, and their physiological parameters, pain, and comfort are measured before and after the heel prick. Data collection includes the Neonatal Infant Pain Scale, Newborn Comfort Behaviour Scale, and other newborn information. Statistical analysis will compare the effects among the three groups to determine differences in pain and comfort during the procedure. The study duration is from March to December 2025, with assessments occurring on the day of the heel prick.

Pain and Comfort Levels During Heel Stick Blood Sampling in Newborns