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

July 6, 2026 updated by: Ayşegül Şimşek, Marmara University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

147

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • İzmit
      • Kocaeli, İzmit, Turkey (Türkiye), 41060
        • Kocaeli City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ShotBlocker
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
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.
Experimental: Warm Gel Pack
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
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
No Intervention: Routine Care
Participants received routine heel prick testing without ShotBlocker or warm gel pack application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal Infant Pain Scale (NIPS) Score
Time Frame: Immediately after heel prick testing
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate
Time Frame: Before and immediately after heel prick testing
Heart rate was measured before and immediately after heel prick testing.
Before and immediately after heel prick testing
Respiratory Rate
Time Frame: Before and immediately after heel prick testing
Respiratory rate was measured before and immediately after heel prick testing.
Before and immediately after heel prick testing
Oxygen Saturation
Time Frame: Before and immediately after heel prick testing
Oxygen saturation was measured before and immediately after heel prick testing.
Before and immediately after heel prick testing
Heel Temperature
Time Frame: Before and immediately after heel prick testing
Heel temperature was measured before and immediately after heel prick testing.
Before and immediately after heel prick testing
Neonatal Comfort Behavior Scale (NCBS) Score
Time Frame: Before and immediately after heel prick testing
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
Before and immediately after heel prick testing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Investigators

  • Principal Investigator: Aysegul Simsek, PhD, Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Actual)

May 1, 2026

Study Completion (Actual)

May 1, 2026

Study Registration Dates

First Submitted

June 30, 2026

First Submitted That Met QC Criteria

June 30, 2026

First Posted (Actual)

July 7, 2026

Study Record Updates

Last Update Posted (Actual)

July 8, 2026

Last Update Submitted That Met QC Criteria

July 6, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEOHEEL-2026-RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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