Can a plastic tool or vibrating pen make baby shots less painful?
NCT ID NCT07379034
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested two simple devices—ShotBlocker and a vibration pen—to see if they could reduce pain in healthy infants during routine vaccinations. 96 babies aged 2-6 months were randomly assigned to one of the devices or a control group. Pain was measured using a standard scale before, during, and after the shot.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ShotBlocker device and vibration pen device
- What this could lead to
- If effective, these simple devices could provide a drug-free way to reduce pain in infants during vaccinations.
- What could go wrong
- This is a small, completed study with only 96 infants. Results may not apply to all babies or other procedures, and the devices may not significantly reduce pain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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96 people
The number who actually took part.
- Started
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Oct 2025
- Finished
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Jan 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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2 to 6 months
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Healthy infant aged 2-6 months * Written consent from the parent Exclusion Criteria: * Premature infants born before 37 weeks * Infants with severe neurodevelopmental disorders * Presence of acute infection or fever * History of a previous serious vaccine reaction
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Ataturk University
Yakutiye, Erzurum, 25240, Turkey (Türkiye)
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