ShotBlocker and Warm Gel Pack During Neonatal Heel Prick (HEAL)

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 2025 and May 2026. 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 Neonatal Comfort Behavior Scale (NCBS). 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.

NCT Number	NCT07686627
Lead Sponsor	Marmara University
Conditions	Procedural Pain, Heel Prick, Newborn
Enrollment	147 participants
Start Date	2025-10-01
Primary Completion	2026-05-01 (estimated)
Study Completion	2026-05-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-08