PainRandomizedNCT07367659
Non-Pharmacological Methods in Reducing Injection Pain
A study testing ShotBlocker, HSTT and Palm in people with Pain and Preschool Age Children, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
In emergency departments, various methods can be used to reduce the pain experienced by children. However, the most important requirement is that the selected method provides rapid 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
- Pain, Preschool Age Children, Injection
- What is being tested?
- ShotBlocker, HSTT and Palm
- 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 Dec 2025to 17 Jan 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 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: Comparison of the Effectiveness of Different Non-Pharmacological Methods in Reducing Injection Pain in Preschool Children: Randomized Controlled Trial
In emergency departments, various methods can be used to reduce the pain experienced by children. However, the most important requirement is that the selected method provides rapid and effective results. Accordingly, it is essential that interventions performed in emergency settings are carried out in a way that enables children to experience the least possible pain and anxiety and that the long-term effects of pain are prevented. Recently, the Helfer Skin Tap Technique (HSTT), which is applied to reduce stress and pain, and the palm stimulator, which is held in the palm and has raised projections on its surface to reduce pain perception by facilitating distraction, have attracted attention. ShotBlocker is a noninvasive, U-shaped plastic device with small projections that is used to reduce injection-related pain in children who are sensitive to pain. In addition, a bee-shaped device called Buzzy®, which combines external cold application and vibration, is also widely used. These methods have been proven to be effective in reducing pain in pediatric patients during invasive procedures such as intramuscular injections and intravenous cannulation.
- Conditions
- Pain, Preschool Age Children, Injection, Fear
- Being tested
- ShotBlocker, HSTT, Palm
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShotBlockerOther
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.
HSTTOther
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).
PalmOther
The Palm Stimulator is 1.6 cm in diameter and 4 cm in length, and has a cylindrical, non-slip, and easy-to-grip structure designed to maximize palm contact. The Palm Stimulator is used by gripping it in the palm during injection. The device has blunt protrusions all around the palm to provide tactile stimulation. These blunt protrusions do not penetrate the skin but, according to gate control theory, create stimulation and close the pain gate in the spinal cord, reducing the pain perceived during injection. The researcher will show the Palm Stimulator, the device providing tactile stimulation, and allow examination. Twenty seconds before the injection, the Palm Stimulator will be placed in the palm of the child's dominant hand so that the child can grasp it. The child will be instructed to hold the device firmly in their palm throughout the procedure. After the injection is complete, the device will be removed from the child.
| Study group | Role | What they receive |
|---|---|---|
| intervention group Palm | Experimental | Palm stimulator Receives: Other: Palm |
| intervention group ShotBloker | Experimental | ShotBloker device Receives: Other: ShotBlocker |
| intervention group HSTT | Experimental | HSTT application Receives: Other: HSTT |
| Control group | No intervention | Rutin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Rating Scale
The 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: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start25 Dec 2025
- Primary completion15 Jan 2026
- Study completion17 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Model description
- 32 intervention, 1 control
- 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
- NCT07367659
- Sponsor's protocol ID
- TiryakiÖ.
- Acronym
- Randomized
- Status last verified
- Jan 2026
- First submitted
- 17 Jan 2026
- Last updated
- 26 Jan 2026
- 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 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Different Non-Pharmacological Methods in Reducing Injection Pain in Preschool Children: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07367659
- Acronym / sponsor ID
- Randomized / TiryakiÖ.
- Conditions
- Pain, Preschool Age Children, Injection, Fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 25 Dec 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 17 Jan 2026 (actual)
- First posted
- 26 Jan 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.
In emergency departments, various methods can be used to reduce the pain experienced by children. However, the most important requirement is that the selected method provides rapid and effective results. Accordingly, it is essential that interventions performed in emergency settings are carried out in a way that enables children to experience the least possible pain and anxiety and that the long-term effects of pain are prevented. Recently, the Helfer Skin Tap Technique (HSTT), which is applied to reduce stress and pain, and the palm stimulator, which is held in the palm and has raised projections on its surface to reduce pain perception by facilitating distraction, have attracted attention. ShotBlocker is a noninvasive, U-shaped plastic device with small projections that is used to reduce injection-related pain in children who are sensitive to pain. In addition, a bee-shaped device called Buzzy®, which combines external cold application and vibration, is also widely used. These methods have been proven to be effective in reducing pain in pediatric patients during invasive procedures such as intramuscular injections and intravenous cannulation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 32 intervention, 1 control
| Arm | Type | Receives |
|---|---|---|
| intervention group Palm | Experimental | Other: PalmPalm stimulator |
| intervention group ShotBloker | Experimental | Other: ShotBlockerShotBloker device |
| intervention group HSTT | Experimental | Other: HSTTHSTT application |
| Control group | No intervention | –Rutin |
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 |
|---|---|---|
| ShotBlockerShotBlocker 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 |
| HSTTHelfer 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 HSTT |
| PalmThe Palm Stimulator is 1.6 cm in diameter and 4 cm in length, and has a cylindrical, non-slip, and easy-to-grip structure designed to maximize palm contact. The Palm Stimulator is used by gripping it in the palm during injection. The device has blunt protrusions all around the palm to provide tactile stimulation. These blunt protrusions do not penetrate the skin but, according to gate control theory, create stimulation and close the pain gate in the spinal cord, reducing the pain perceived during injection. The researcher will show the Palm Stimulator, the device providing tactile stimulation, and allow examination. Twenty seconds before the injection, the Palm Stimulator will be placed in the palm of the child's dominant hand so that the child can grasp it. The child will be instructed to hold the device firmly in their palm throughout the procedure. After the injection is complete, the device will be removed from the child. | Other | intervention group Palm |
Primary outcome
Pain Rating Scale
Time frame: 6 weeks
The 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.
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 26 Jan 2026.
- 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 ShotBlocker, HSTT and Palm in people with Pain and Preschool Age Children, 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 26 Jan 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?
Pain Rating Scale (time frame: 6 weeks). 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 26 Jan 2026.