Heel Prick, Newborn, Procedural Pain
Conditions
Keywords
Newborn, Heel Prick, Procedural Pain, ShotBlocker, Warm Gel Pack, Pain Management, Neonatal Pain, Nonpharmacological Intervention, NIPS, NCBS
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.
Interventions
DEVICEShotBlocker
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.
DEVICEWarm 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
Sponsors
Marmara University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
0 Days to 1 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal Infant Pain Scale (NIPS) Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Neonatal Comfort Behavior Scale (NCBS) Score | 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 |
| Heart Rate | Before and immediately after heel prick testing | Heart rate was measured before and immediately after heel prick testing. |
| Respiratory Rate | Before and immediately after heel prick testing | Respiratory rate was measured before and immediately after heel prick testing. |
| Oxygen Saturation | Before and immediately after heel prick testing | Oxygen saturation was measured before and immediately after heel prick testing. |
| Heel Temperature | Before and immediately after heel prick testing | Heel temperature was measured before and immediately after heel prick testing. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORAysegul Simsek, PhD
Marmara University
Outcome results
None listed