An interventional study of ShotBlocker and Warm Gel Pack in Neonatal Pain and Procedural Pain, sponsored by Istinye University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 1 Day to 28 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Istinye University · Not applicable, Interventional, and Supportive care
Newborns routinely undergo heel stick procedures for blood screening tests shortly after birth. Although the procedure is brief, it can cause pain, stress, and physiological changes. Effective pain management is important because early painful experiences may affect newborn well-being and development.
Nonpharmacological methods are commonly used to reduce procedural pain in newborns because they are safe, easy to apply, and inexpensive. Two such methods are the ShotBlocker device, which provides tactile stimulation to reduce pain perception, and warm gel packs, which increase local blood flow and may improve comfort during the procedure. However, evidence regarding their effectiveness during heel stick procedures remains limited. This randomized controlled trial was conducted to compare the effects of ShotBlocker and warm gel pack applications during heel stick procedures in healthy term newborns. A total of 147 newborns were randomly assigned to a ShotBlocker group, a warm gel pack group, or a control group receiving routine care. The study evaluated procedural pain using the Neonatal Infant Pain Scale (NIPS), comfort using the Neonatal Comfort Behavior Scale, and physiological responses including heart rate, respiratory rate, oxygen saturation, and heel temperature. The findings may help identify practical, noninvasive approaches to improve pain management and comfort during routine newborn procedures.
Heel stick blood sampling is one of the most frequently performed painful procedures in newborn care. Although the procedure is brief, it may trigger behavioral and physiological pain responses. Effective management of procedural pain is an important component of neonatal care because early painful experiences may influence short- and long-term outcomes. Nonpharmacological interventions are widely recommended for the management of procedural pain in newborns because they are safe, inexpensive, and easy to implement in clinical settings. ShotBlocker is a device designed to reduce pain perception through tactile stimulation based on the gate control theory of pain. Warm gel packs may promote local vasodilation, increase peripheral circulation, and potentially reduce discomfort during heel stick procedures. However, evidence comparing these interventions during heel stick blood sampling is limited. This study was designed as a three-arm randomized controlled trial to evaluate the effects of ShotBlocker and warm gel pack applications on pain, comfort, and physiological responses during heel stick procedures in healthy term newborns. Participants were randomly assigned to a ShotBlocker group, a warm gel pack group, or a control group receiving routine care. Pain was assessed using the Neonatal Infant Pain Scale (NIPS), and comfort was assessed using the Neonatal Comfort Behavior Scale. Physiological parameters, including heart rate, respiratory rate, oxygen saturation, and heel temperature, were measured before and after the procedure. The results of this study may contribute to the evidence base regarding practical nonpharmacological strategies for procedural pain management in newborns.
241 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.
This study's enrollment of 147 is above the median of 90 across 227 interventional studies indexed under Pain, Procedural.
Browse Pain, Procedural studies →Istinye University is the lead sponsor of 221 studies on the registry; 94 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy term newborns in this group received the ShotBlocker device during the heel stick procedure. The device was applied around the puncture site according to the study protocol to provide tactile stimulation during the procedure.
Device: ShotBlocker
Healthy term newborns in this group received a warm gel pack application before the heel stick procedure according to the study protocol.
Other: Warm Gel Pack
Healthy term newborns in this group received routine heel stick care without ShotBlocker or warm gel pack application.
The ShotBlocker device was applied around the heel puncture site during the heel stick procedure according to the study protocol. The device provides multiple points of tactile stimulation intended to reduce pain perception during the procedure.
A warm gel pack was applied to the heel before the heel stick procedure according to the study protocol. The intervention was intended to increase local warmth and circulation during blood sample collection.
Neonatal Infant Pain Scale (NIPS) Score After Heel Stick Procedure
Pain response measured using the Neonatal Infant Pain Scale (NIPS) immediately after the heel stick procedure. Higher scores indicate greater pain response.
Time frame: Immediately after the heel stick procedure
Neonatal Comfort Behavior Scale (NCBS) Score
Comfort level measured using the Neonatal Comfort Behavior Scale before and after the heel stick procedure.
Time frame: Before and immediately after the heel stick procedure
Heart Rate Change
Difference between pre-procedure and post-procedure heart rate measurements.
Time frame: Immediately before and immediately after the heel stick procedure
Respiratory Rate Change
Difference between pre-procedure and post-procedure respiratory rate measurements.
Time frame: Immediately before and immediately after the heel stick procedure
Oxygen Saturation Change
Difference between pre-procedure and post-procedure oxygen saturation measurements.
Time frame: Immediately before and immediately after the heel stick procedure
Heel Temperature Change
Difference between pre-procedure and post-procedure heel temperature measurements.
Time frame: Immediately before and immediately after the heel stick procedure
Plan to share: No
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