Procedural PainHEALNCT07686627
ShotBlocker and Warm Gel Pack During Neonatal Heel Prick (HEAL)
A study testing ShotBlocker and Warm Gel Pack in people with Procedural Pain and Heel Prick, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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 2024 and October 2025. Read more about this study
- Who is it for?
- Ages 0 days to 1 monthHealthy volunteers can take part
- Conditions the study is for
- Procedural Pain, Heel Prick, Newborn
- 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
- 139 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Oct 2024to 1 Oct 2025
- 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 0 days to 1 month
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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 2024 and October 2025. 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 COMFORTneo. 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.
- Conditions
- Procedural Pain, Heel Prick, Newborn
- Being tested
- ShotBlocker, Warm Gel Pack
- Keywords
- Newborn, Heel Prick, Procedural Pain, ShotBlocker, Warm Gel Pack, Pain Management, Neonatal Pain, Nonpharmacological Intervention, NIPS, NCBS, COMFORTneo
- 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 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 PackDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ShotBlocker |
| 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. Receives: Device: Warm Gel Pack |
| Routine Care | No intervention | Participants received routine heel prick testing 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
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.
Measured: Immediately after heel prick testing
Secondary outcomes (5)
COMFORTneo
Comfort will be assessed before and immediately after heel prick using the COMFORTneo. 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
Measured: Before and immediately after heel prick testing
Heart Rate
Heart rate was measured before and immediately after heel prick testing.
Measured: Before and immediately after heel prick testing
Respiratory Rate
Respiratory rate was measured before and immediately after heel prick testing.
Measured: Before and immediately after heel prick testing
Oxygen Saturation
Oxygen saturation was measured before and immediately after heel prick testing.
Measured: Before and immediately after heel prick testing
Heel Temperature
Heel temperature was measured before and immediately after heel prick testing.
Measured: Before and immediately after heel prick testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start8 Oct 2024
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned 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 blood sampling.
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşegül Şimşek, Marmara University
- Investigators
- Aysegul Simsek, PhD, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686627
- Sponsor's protocol ID
- NEOHEEL-2026-RCT
- Acronym
- HEAL
- Status last verified
- Sep 2026
- First submitted
- 30 Jun 2026
- Last updated
- 20 Oct 2026
- Results posted
- 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 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07686627
- Acronym / sponsor ID
- HEAL / NEOHEEL-2026-RCT
- Conditions
- Procedural Pain, Heel Prick, Newborn
- Keywords
- Newborn, Heel Prick, Procedural Pain, ShotBlocker, Warm Gel Pack, Pain Management, Neonatal Pain, Nonpharmacological Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 7 Jul 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.
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 2024 and October 2025. 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 COMFORTneo. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants were assigned 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 blood sampling.
| Arm | Type | Receives |
|---|---|---|
| ShotBlocker | Experimental | Device: ShotBlockerParticipants received the ShotBlocker device during routine heel prick testing. The device was placed at the heel puncture site immediately before the procedure. |
| Warm Gel Pack | Experimental | Device: Warm Gel PackParticipants 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. |
| Routine Care | No intervention | –Participants received routine heel prick testing without ShotBlocker or warm gel pack application. |
Who may qualify
- Ages
- 0 days to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 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. | Device | ShotBlocker |
| Warm Gel PackA 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 | Device | Warm Gel Pack |
Primary outcome
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.
5 secondary outcomes
COMFORTneo
Time frame: Before and immediately after heel prick testing
Heart Rate
Time frame: Before and immediately after heel prick testing
Respiratory Rate
Time frame: Before and immediately after heel prick testing
Oxygen Saturation
Time frame: Before and immediately after heel prick testing
Heel Temperature
Time frame: Before and immediately after heel prick testing
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 20 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Aysegul Simsek, PhD 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 Procedural Pain and Heel Prick, run by Marmara 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 6 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 20 Oct 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 (time frame: Immediately after heel prick testing). 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 20 Oct 2026.