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Completed

NCT Number: NCT07686627

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.

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Key information

Conditions

Procedural Pain Agnosia Heel Prick Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Newborn Pain Pain, Procedural Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

0 day–1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli City Hospital

Kocaeli, İzmit, 41060, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. Heart Rate

    Time frame: Before and immediately after heel prick testing

    Heart rate was measured before and immediately after heel prick testing.

  3. Respiratory Rate

    Time frame: Before and immediately after heel prick testing

    Respiratory rate was measured before and immediately after heel prick testing.

  4. Oxygen Saturation

    Time frame: Before and immediately after heel prick testing

    Oxygen saturation was measured before and immediately after heel prick testing.

  5. Heel Temperature

    Time frame: Before and immediately after heel prick testing

    Heel temperature was measured before and immediately after heel prick testing.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study 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

Acronym: HEAL

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 7, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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