ChildrenNCT07190547
Helfer Technique and ShotBlocker in Reducing Pain, Fear, and Anxiety in Children
A study testing ShotBloker and Helfer skin tap in people with Children and Preschool, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
Various methods can be used to reduce pain experienced by children in emergency departments. However, the most critical requirement is that the method used must provide fast and effective results. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Children, Preschool, Pain Management
- What is being tested?
- ShotBloker and Helfer skin tap
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Sep 2025to 20 Dec 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Helfer Technique and ShotBlocker Application on Pain, Fear, and Anxiety in Children Receiving Intramuscular Injections: A Randomized Controlled Trial
Various methods can be used to reduce pain experienced by children in emergency departments. However, the most critical requirement is that the method used must provide fast and effective results. Accordingly, it is essential that interventions in emergency settings are performed in a way that minimizes pain and anxiety in children and helps prevent the long-term consequences of pain (1, 2). Recently, the Helfer Skin Tap Technique (HSTT)-used to reduce stress and pain-and the ShotBlocker®, a device with small projections designed to reduce pain when applied to the skin, have gained attention (3,4,5). ShotBlocker is a non-invasive, U-shaped plastic device with small bumps, used to decrease injection-related pain, especially in children who are highly sensitive to pain (6).
In addition, a device known as Buzzy®, shaped like a bee and combining external cold application with vibration, is also commonly used. It has been proven effective in reducing pain during invasive procedures such as intramuscular (IM) injections and IV line insertions in pediatric patients (7,8). The analgesic effect of the Buzzy® device is attributed to two main mechanisms: reduced signal transmission in peripheral nerves and the gate control theory. The application of cold and vibrational stimuli to the skin activates tactile receptors, leading to the release of endogenous opioids and a subsequent decrease in pain perception (8).
Read more
Reducing pain and fear during IM injections-one of the most common painful procedures in pediatric emergency departments-is a key midwifery/nursing intervention. The authority of midwives and nurses to use non-pharmacological methods during IM injections is clearly defined in their respective professional regulations. Given the nature of pediatric emergency units, midwives and nurses contribute significantly to increasing both child and parent comfort by using practical, fast-acting, and low-cost methods that can be easily implemented during painful procedures.
Demonstrating the positive effects of non-pharmacological methods on reducing pain and fear in children of different age groups during IM injections is crucial, both for enriching the literature and for encouraging the widespread use of evidence-based, cost-effective practices in clinical settings. Making such approaches a routine part of care delivery in pediatric units is of great importance.
The aim of the study was to investigate the effects of ShotBlocker and HSTT on the pain and fear experienced by children aged 4-6 years during IM injection in pediatric emergency departments.
- Conditions
- Children, Preschool, Pain Management
- Being tested
- ShotBloker, Helfer skin tap
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShotBlokerOther
ShotBlocker is a flat, horseshoe-shaped device used to reduce pain during subcutaneous or intramuscular (IM) injections. It features short, blunt, non-sharp projections approximately 2 mm in height and is designed to be placed against the skin, with a central opening that exposes the injection site. The device is applied to the skin just prior to injection, with its textured surface making contact with the skin. Although the projections do not penetrate the skin, they are believed to create a sensory stimulus associated with pain modulation based on the gate control theory.
Helfer skin tapOther
Helfer Skin Tap Technique:
After determining the injection site, gently tap the skin several times with the fingertips of the dominant (most commonly used) hand for approximately 5 seconds to relax the muscle. After the skin is wiped with antiseptic solution and stretched, the cap of the syringe in the dominant (most commonly used) hand is opened. A large V is made with the thumb and index finger of the non-dominant hand. The skin is tapped three times quickly using the whole hand to stimulate the major muscle fibers. The nurse/midwife counts to 3, and the needle is inserted into the muscle at a 90-degree angle simultaneously. To remove the needle from the skin, the skin is tapped three times quickly (again in a V shape) with the whole non-dominant hand, and the needle is withdrawn simultaneously with the final tap (tapping).
| Study group | Role | What they receive |
|---|---|---|
| intervention group (ShotBloker ) | Experimental | ShotBloker Receives: Other: ShotBloker |
| Control group | No intervention | Not described |
| intervention group (helper skin tap) | Experimental | Not described Receives: Other: Helfer skin tap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement Tool
he Wong-Baker FACES Pain Rating Scale was used to assess self-reported pain levels. This scale consists of six facial expressions ranging from "no hurt" (0) to "hurts worst" (10), allowing children to select the face that best represents their level of pain.
Measured: 12 weeks
Assessment Time
Pain scores were recorded immediately after the injection.Developed by Wong and Baker, it features six hand-drawn facial expressions on a horizontal plane. Scored from 0 to 10, the leftmost face features a smiling face, representing "no pain." Pain increases from left to right. The rightmost face features a face with tears, representing "unbearable pain."
Measured: 12 weeks
Measurement Tool (Fear Level)
The Children's Fear Scale was used to assess the child's level of fear. This visual scale consists of five facial expressions depicting increasing levels of fear (scores range from 0 to 4). from neutral expression (0=no anxiety) to frightened face (4=severe anxiety)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start25 Sep 2025
- Primary completion15 Oct 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildrenStudies of the same condition, open and under way.
- More trials run by Sakarya 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, öznur tiryaki, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190547
- Sponsor's protocol ID
- Nalan Yalçınkaya Sezer
- Status last verified
- Dec 2025
- First submitted
- 18 Jul 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ethically, patient information can be shared upon reasonable request without revealing their identities for security reasons.
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Helfer Technique and ShotBlocker Application on Pain, Fear, and Anxiety in Children Receiving Intramuscular Injections: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07190547
- Acronym / sponsor ID
- Nalan Yalçınkaya Sezer
- Conditions
- Children, Preschool, Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 24 Sep 2025 (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.
Various methods can be used to reduce pain experienced by children in emergency departments. However, the most critical requirement is that the method used must provide fast and effective results. Accordingly, it is essential that interventions in emergency settings are performed in a way that minimizes pain and anxiety in children and helps prevent the long-term consequences of pain (1, 2). Recently, the Helfer Skin Tap Technique (HSTT)-used to reduce stress and pain-and the ShotBlocker®, a device with small projections designed to reduce pain when applied to the skin, have gained attention (3,4,5). ShotBlocker is a non-invasive, U-shaped plastic device with small bumps, used to decrease injection-related pain, especially in children who are highly sensitive to pain (6).
In addition, a device known as Buzzy®, shaped like a bee and combining external cold application with vibration, is also commonly used. It has been proven effective in reducing pain during invasive procedures such as intramuscular (IM) injections and IV line insertions in pediatric patients (7,8). The analgesic effect of the Buzzy® device is attributed to two main mechanisms: reduced signal transmission in peripheral nerves and the gate control theory. The application of cold and vibrational stimuli to the skin activates tactile receptors, leading to the release of endogenous opioids and a subsequent decrease in pain perception (8).
Reducing pain and fear during IM injections-one of the most common painful procedures in pediatric emergency departments-is a key midwifery/nursing intervention. The authority of midwives and nurses to use non-pharmacological methods during IM injections is clearly defined in their respective professional regulations. Given the nature of pediatric emergency units, midwives and nurses contribute significantly to increasing both child and parent comfort by using practical, fast-acting, and low-cost methods that can be easily implemented during painful procedures.
Demonstrating the positive effects of non-pharmacological methods on reducing pain and fear in children of different age groups during IM injections is crucial, both for enriching the literature and for encouraging the widespread use of evidence-based, cost-effective practices in clinical settings. Making such approaches a routine part of care delivery in pediatric units is of great importance.
The aim of the study was to investigate the effects of ShotBlocker and HSTT on the pain and fear experienced by children aged 4-6 years during IM injection in pediatric emergency departments.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intervention group (ShotBloker ) | Experimental | Other: ShotBlokerShotBloker |
| Control group | No intervention | – |
| intervention group (helper skin tap) | Experimental | Other: Helfer skin tap |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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,
Key exclusion criteria (6 listed)
- 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),
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 |
|---|---|---|
| ShotBlokerShotBlocker is a flat, horseshoe-shaped device used to reduce pain during subcutaneous or intramuscular (IM) injections. It features short, blunt, non-sharp projections approximately 2 mm in height and is designed to be placed against the skin, with a central opening that exposes the injection site. The device is applied to the skin just prior to injection, with its textured surface making contact with the skin. Although the projections do not penetrate the skin, they are believed to create a sensory stimulus associated with pain modulation based on the gate control theory. | Other | intervention group (ShotBloker ) |
| Helfer skin tapHelfer Skin Tap Technique: After determining the injection site, gently tap the skin several times with the fingertips of the dominant (most commonly used) hand for approximately 5 seconds to relax the muscle. After the skin is wiped with antiseptic solution and stretched, the cap of the syringe in the dominant (most commonly used) hand is opened. A large V is made with the thumb and index finger of the non-dominant hand. The skin is tapped three times quickly using the whole hand to stimulate the major muscle fibers. The nurse/midwife counts to 3, and the needle is inserted into the muscle at a 90-degree angle simultaneously. To remove the needle from the skin, the skin is tapped three times quickly (again in a V shape) with the whole non-dominant hand, and the needle is withdrawn simultaneously with the final tap (tapping). | Other | intervention group (helper skin tap) |
Primary outcome
Measurement Tool
Time frame: 12 weeks
he Wong-Baker FACES Pain Rating Scale was used to assess self-reported pain levels. This scale consists of six facial expressions ranging from "no hurt" (0) to "hurts worst" (10), allowing children to select the face that best represents their level of pain.
Assessment Time
Time frame: 12 weeks
Pain scores were recorded immediately after the injection.Developed by Wong and Baker, it features six hand-drawn facial expressions on a horizontal plane. Scored from 0 to 10, the leftmost face features a smiling face, representing "no pain." Pain increases from left to right. The rightmost face features a face with tears, representing "unbearable pain."
Measurement Tool (Fear Level)
Time frame: 12 weeks
The Children's Fear Scale was used to assess the child's level of fear. This visual scale consists of five facial expressions depicting increasing levels of fear (scores range from 0 to 4). from neutral expression (0=no anxiety) to frightened face (4=severe anxiety)
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 30 Dec 2025.
- Individual participant dataSharing planned: No. Ethically, patient information can be shared upon reasonable request without revealing their identities for security reasons.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ShotBloker and Helfer skin tap in people with Children and Preschool, run by Sakarya 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 11 inclusion and 6 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 30 Dec 2025. 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?
Measurement Tool (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 30 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.