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

NCT07686627 | Completed

• 1 other identifier: NEOHEEL-2026-RCT
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Procedural Pain; Heel Prick; Newborn

Keywords

Newborn; Heel Prick; Procedural Pain; ShotBlocker; Warm Gel Pack; Pain Management; Neonatal Pain; Nonpharmacological Intervention; NIPS; NCBS

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately after heel prick testing

Secondary Outcomes (5)

• Neonatal Comfort Behavior Scale (NCBS) Score

  Before and immediately after heel prick testing

• Heart Rate

  Before and immediately after heel prick testing

• Respiratory Rate

  Before and immediately after heel prick testing

• Oxygen Saturation

  Before and immediately after heel prick testing

• Heel Temperature

  Before and immediately after heel prick testing

Study Arms (3)

ShotBlocker

EXPERIMENTAL

Participants received the ShotBlocker device during routine heel prick testing. The device was placed at the heel puncture site immediately before the procedure.

Device: ShotBlocker

Warm Gel Pack

EXPERIMENTAL

Participants received a warm gel pack before routine heel prick testing. The gel pack was applied to the heel until the target temperature of 38-40°C was reached before blood sampling.

Device: Warm Gel Pack

Routine Care

NO INTERVENTION

Participants received routine heel prick testing without ShotBlocker or warm gel pack application.

Interventions

ShotBlocker DEVICE

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.

ShotBlocker

Warm Gel Pack DEVICE

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

Warm Gel Pack

Eligibility Criteria

• Age: 0 Days - 1 Month
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age ≥38 weeks
• Healthy newborn
• Scheduled for routine heel prick testing as part of the newborn screening program
• minute APGAR score ≥7
• No acute illness causing pain
• No invasive procedures other than Hepatitis B vaccination after birth

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Kocaeli City Hospital

Kocaeli, İzmit, 41060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Procedural; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Aysegul Simsek, PhD

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This was an open-label study. Due to the nature of the interventions (ShotBlocker and warm gel pack), blinding of participants and care providers was not possible. Statistical analyses were performed using blinded group codes to minimize analysis bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants were randomly assigned in a 1:1:1 ratio to the ShotBlocker group, warm gel pack group, or routine care control group. Each participant received only the intervention assigned to their study arm during routine heel prick testing

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start: October 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: July 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)