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Completed
NCT07686627
ShotBlocker and Warm Gel Pack During Neonatal Heel Prick (HEAL)
Conditions: Procedural Pain, Heel Prick, Newborn
Sex: All
Ages: 0 Days – 1 Month
Healthy volunteers: Yes
Phase: NA
Enrollment: 139
Sponsor: Marmara University
Location: Kocaeli City Hospital Kocaeli İzmit
Summary
This study evaluated the effects of ShotBlocker and a warm gel pack on pain, comfort, and physiological parameters during heel prick testing in healthy term newborns. A three-arm randomized controlled trial was conducted at a city hospital between October 2024 and October 2025. Newborns were randomly assigned to the ShotBlocker group, warm gel pack group, or routine care group. Pain was assessed using the Neonatal Infant Pain Scale (NIPS), and comfort was assessed using the COMFORTneo. Heart rate, respiratory rate, oxygen saturation, and heel temperature were also measured before and after the procedure. The study aimed to compare the effectiveness of these non-pharmacological interventions during routine heel prick testing.
Eligibility Criteria
Inclusion Criteria:
* Gestational age ≥38 weeks
* Healthy newborn
* Scheduled for routine heel prick testing as part of the newborn screening program
* 1-minute APGAR score ≥7
* No acute illness causing pain
* No invasive procedures other than Hepatitis B vaccination after birth
Exclusion Criteria:
* Mother does not speak Turkish
* Parent unwilling to participate
* Multiple pregnancy
* Maternal or fetal complications during delivery
* Known or suspected genetic or metabolic disorder in the mother or infant
Source: ClinicalTrials.gov (NCT07686627). StuddyBuddy aggregates publicly available trial information.