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NCT07686627
NA

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

Sponsor: Marmara University

View on ClinicalTrials.gov

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 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.

Official title: Effects of ShotBlocker and Warm Gel Pack During Heel Prick Testing on Pain, Comfort, and Physiological Parameters in Healthy Term Newborns: A Three-Arm Randomized Controlled Trial

Key Details

Gender

All

Age Range

0 Days - 1 Month

Study Type

INTERVENTIONAL

Enrollment

147

Start Date

2025-10-01

Completion Date

2026-05-01

Last Updated

2026-07-07

Healthy Volunteers

Yes

Interventions

DEVICE

ShotBlocker

The ShotBlocker device was applied at the heel puncture site during routine heel prick testing. The device was positioned immediately before the procedure and remained in place during blood collection.

DEVICE

Warm Gel Pack

A single-use warm gel pack was applied to the heel before routine heel prick testing. The heel temperature was maintained between 38°C and 40°C before blood sampling

Locations (1)

Kocaeli City Hospital

Kocaeli, İzmit, Turkey (Türkiye)