Neonatal PainWARM-SHOTNCT07921628
Effect of ShotBlocker and Warm Gel Pack on Heel Stick Pain in Newborns
A study testing ShotBlocker and Warm Gel Pack in people with Neonatal Pain and Procedural Pain, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Neonatal Pain, Procedural Pain
- What is being tested?
- ShotBlocker and Warm Gel Pack
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 30 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy term newborns (37-42 weeks of gestation)
- Undergoing routine heel stick blood sampling
- Clinically stable at the time of the procedure
- Parental written informed consent obtained
Who cannot join
- Preterm or post-term newborns
- Presence of congenital anomalies
- Neurological disorders or conditions affecting pain responses
- Receipt of analgesic or sedative medication before the procedure
- Any medical condition requiring intensive care or causing clinical instability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of ShotBlocker and Warm Gel Pack Applications During Heel Stick Procedures on Pain, Comfort, and Physiological Parameters in Healthy Term Newborns: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Neonatal Pain, Procedural Pain
- Being tested
- ShotBlocker, Warm Gel Pack
- Keywords
- Neonatal Pain, Procedural Pain, Heel Stick, Newborn, Pain Management, ShotBlocker, Warm Gel Pack, Comfort, Physiological Parameters, Randomized Controlled Trial
- Medical subject headings
- Pain, Procedural, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShotBlockerDevice
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.
Warm Gel PackOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ShotBlocker Group | Experimental | 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. Receives: Device: ShotBlocker |
| Warm Gel Pack Group | Experimental | Healthy term newborns in this group received a warm gel pack application before the heel stick procedure according to the study protocol. Receives: Other: Warm Gel Pack |
| Control Group | No intervention | Healthy term newborns in this group received routine heel stick care without ShotBlocker or warm gel pack application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after the heel stick procedure
Secondary outcomes (5)
Neonatal Comfort Behavior Scale (NCBS) Score
Comfort level measured using the Neonatal Comfort Behavior Scale before and after the heel stick procedure.
Measured: Before and immediately after the heel stick procedure
Heart Rate Change
Difference between pre-procedure and post-procedure heart rate measurements.
Measured: Immediately before and immediately after the heel stick procedure
Respiratory Rate Change
Difference between pre-procedure and post-procedure respiratory rate measurements.
Measured: Immediately before and immediately after the heel stick procedure
Oxygen Saturation Change
Difference between pre-procedure and post-procedure oxygen saturation measurements.
Measured: Immediately before and immediately after the heel stick procedure
Heel Temperature Change
Difference between pre-procedure and post-procedure heel temperature measurements.
Measured: Immediately before and immediately after the heel stick procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Sep 2025
- Primary completion1 May 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal PainStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1:1 ratio to one of three parallel groups: a ShotBlocker group, a warm gel pack group, or a control group receiving routine care during heel stick procedures. Each participant received only the intervention assigned to their study group, and outcomes were compared between groups.
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşegül Şimşek, PhD, Istinye University
- Investigators
- Aysegu Simsek, Ph.D., Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921628
- Sponsor's protocol ID
- 2024/06 24-142
- Acronym
- WARM-SHOT
- Status last verified
- Nov 2026
- First submitted
- 22 Jun 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of ShotBlocker and Warm Gel Pack Applications During Heel Stick Procedures on Pain, Comfort, and Physiological Parameters in Healthy Term Newborns: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07921628
- Acronym / sponsor ID
- WARM-SHOT / 2024/06 24-142
- Conditions
- Neonatal Pain, Procedural Pain
- Keywords
- Neonatal Pain, Procedural Pain, Heel Stick, Newborn, Pain Management, ShotBlocker, Warm Gel Pack, Comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants were randomly assigned in a 1:1:1 ratio to one of three parallel groups: a ShotBlocker group, a warm gel pack group, or a control group receiving routine care during heel stick procedures. Each participant received only the intervention assigned to their study group, and outcomes were compared between groups.
| Arm | Type | Receives |
|---|---|---|
| ShotBlocker Group | Experimental | Device: ShotBlockerHealthy 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. |
| Warm Gel Pack Group | Experimental | Other: Warm Gel PackHealthy term newborns in this group received a warm gel pack application before the heel stick procedure according to the study protocol. |
| Control Group | No intervention | –Healthy term newborns in this group received routine heel stick care without ShotBlocker or warm gel pack application. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy term newborns (37-42 weeks of gestation)
- Undergoing routine heel stick blood sampling
- Clinically stable at the time of the procedure
- Parental written informed consent obtained
Key exclusion criteria (5 listed)
- Preterm or post-term newborns
- Presence of congenital anomalies
- Neurological disorders or conditions affecting pain responses
- Receipt of analgesic or sedative medication before the procedure
- Any medical condition requiring intensive care or causing clinical instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ShotBlockerThe 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. | Device | ShotBlocker Group |
| Warm Gel PackA 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. | Other | Warm Gel Pack Group |
Primary outcome
Neonatal Infant Pain Scale (NIPS) Score After Heel Stick Procedure
Time frame: Immediately after the 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.
5 secondary outcomes
Neonatal Comfort Behavior Scale (NCBS) Score
Time frame: Before and immediately after the heel stick procedure
Heart Rate Change
Time frame: Immediately before and immediately after the heel stick procedure
Respiratory Rate Change
Time frame: Immediately before and immediately after the heel stick procedure
Oxygen Saturation Change
Time frame: Immediately before and immediately after the heel stick procedure
Heel Temperature Change
Time frame: Immediately before and immediately after the heel stick procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Neonatal Pain
RecruitingObservational study
Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics
Familial Mediterranean Fever (FMF), Autoinflammation
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
RecruitingObservational study
MRI Study of Musculoskeletal Function
Abnormalities, Imaging
Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis
Not yet recruiting
Eye Covering and White Noise During Nasogastric Tube Insertion in Preterm Infants
Preterm Infants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aysegu Simsek, Ph.D. principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ShotBlocker and Warm Gel Pack in people with Neonatal Pain and Procedural Pain, run by Istinye University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Infant Pain Scale (NIPS) Score After Heel Stick Procedure (time frame: Immediately after the heel stick procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.