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

Marmara University147 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

147

Conditions

Procedural Pain Heel Prick Newborn

Interventions

Eligibility

Sex: ALLMin age: 0 DaysMax age: 1 MonthHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Neonatal Infant Pain Scale (NIPS) Score

Pain intensity will be assessed immediately after heel prick using the Neonatal Infant Pain Scale (NIPS). The NIPS is a behavioral pain assessment tool consisting of six indicators (facial expression, crying, breathing pattern, arm movements, leg movements, and state of arousal). Total scores range from 0 to 7, with higher scores indicating greater pain intensity. Scores \>3 indicate clinically significant pain.

Time frame: Immediately after heel prick testing

Secondary Outcomes

Neonatal Comfort Behavior Scale (NCBS) Score

Comfort will be assessed before and immediately after heel prick using the Neonatal Comfort Behavior Scale (NCBS). The NCBS consists of six behavioral items, each scored from 1 to 5, yielding a total score ranging from 6 to 30. Higher scores indicate poorer comfort (greater pain/distress), whereas lower scores indicate better comfort. Scores ≥14 indicate discomfort/distress