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Can a plastic device or a skin tap make shots less scary for kids?

NCT ID NCT07190547

Symptom relief Sponsor: Sakarya University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested two non-drug methods to reduce pain, fear, and anxiety in children aged 4 to 6 getting intramuscular injections in a pediatric emergency department. One method used a flat, bumpy plastic device called ShotBlocker pressed against the skin before the shot. The other was the Helfer Skin Tap Technique, a gentle tapping on the skin. The trial enrolled 120 children and measured their pain and fear right after the injection using simple face scales.

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 Helfer Skin Tap Technique
What this could lead to
If effective, these simple, low-cost methods could help reduce pain and fear in young children during routine injections in emergency settings.
What could go wrong
This is a small, completed trial with 120 children, so results may not apply to all settings or age groups. The methods may not work for every child.

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

120 people

The number who actually took part.

Started

Sep 2025

Finished

Dec 2025

Lead sponsor

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

4 to 6 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: * Children aged between 4 and 6 years, * An intramuscular (IM) medication order was prescribed by a physician, * The IM injection was administered in the pediatric emergency department, * No history of chronic pain-causing illness, * No diagnosis of neurodevelopmental disorders, * Had not received any analgesic medications in the past 6 hours, * No history of syncope (fainting) during previous injections, No diagnosis of mental retardation, * No scar tissue or muscle atrophy at the intended injection site, * Body mass index (BMI) percentile between the 10th and 90th percentiles for age and gender, * Both child and parent provided informed consent to participate in the study. Exclusion Criteria; * Participants were excluded from the study if: * The child was younger than 4 or older than 6 years, * There was scar tissue or muscle atrophy at the injection site, * The child or parent had communication difficulties, * The child's BMI was below the 10th percentile (cachectic) or above the 90th percentile (obese), * Either the child or parent declined to participate in the research.

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Conditions

The condition(s) this trial relates to.

agnosia posterior leukoencephalopathy syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Children Pain management Preschool

Contacts and locations

Locations

  • Sakarya University

    Sakarya, Turkey (Türkiye)

More trials for these conditions

Other studies related to the condition(s) this trial covers.