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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Routine Care | No Intervention | Participants received routine heel prick testing without ShotBlocker or warm gel pack application. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aysegul Simsek, PhD | Marmara University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kocaeli City Hospital | Kocaeli | İzmit | 41060 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D000073818 | Pain, Procedural |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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
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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.
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| 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 |
|
| Before and immediately after heel prick testing |
| Heart Rate | Heart rate was measured before and immediately after heel prick testing. | Before and immediately after heel prick testing |
| Respiratory Rate | Respiratory rate was measured before and immediately after heel prick testing. | Before and immediately after heel prick testing |
| Oxygen Saturation | Oxygen saturation was measured before and immediately after heel prick testing. | Before and immediately after heel prick testing |
| Heel Temperature | Heel temperature was measured before and immediately after heel prick testing. | Before and immediately after heel prick testing |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |