ChildrenNCT06851182
The Impact of Helfer Skin Tap and ShotBlocker Techniques on Emotional Responses to Intramuscular Injections in Children
A study testing Helfer skin tap technique and Shotblocker technique in people with Children, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Study Aim: This study aims to determine the effects of the Helfer Skin Tap Technique (HST) and ShotBlocker application on pain, emotional indicators, and physiological parameters during intramuscular (IM) drug administration in children aged 7-12 years. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Children
- What is being tested?
- Helfer skin tap technique and Shotblocker technique
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Sep 2024to 15 Jan 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- - 7 to 12 years old,
- BMI level in the appropriate range according to age,
- IM drug administered to the Vastus Lateralis muscle,
- No disease that causes chronic pain,
- Not taking any analgesic medication in the last 8 hours before the procedure,
- No mental or neurological disability,
Show all 9Show fewer
- No visual or auditory problems preventing the application of the scales,
- Speaks and understands Turkish,
- Children whose parents and themselves agreed to participate in the study were included in the study.
Who cannot join
- - BMI level is not in the appropriate range according to age,
- Forms with incomplete or incorrect answers,
- Children who did not volunteer to participate in the study were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Different Skin Stimulation Techniques on Intramuscular Injection Pain and Emotional Responses in Children: Helfer Skin Tap Technique and ShotBlocker
Study Aim: This study aims to determine the effects of the Helfer Skin Tap Technique (HST) and ShotBlocker application on pain, emotional indicators, and physiological parameters during intramuscular (IM) drug administration in children aged 7-12 years.
Study Design This research is designed as a randomized controlled experimental study.
Read more
Study Setting and Characteristics The study will be conducted at the Pediatric Emergency Clinic of Fırat University Hospital. The Pediatric Emergency Clinic consists of two observation rooms with a total of 12 beds, where children's medication administration and follow-ups are carried out.
The study population comprises children aged 7-12 years who received Vastus Lateralis IM drug administration (ZOFER® 8mg/4ml Injectable Solution - Ondansetron Hydrochloride Dihydrate) at the Pediatric Emergency Clinic of Fırat University Hospital and met the inclusion criteria during the specified study period.
For sample size estimation, the pain scores from the study by Sivri, Bilgen, and Balcı (2019) were considered. Based on their findings (d = 0.82; α = 0.05), it was determined that a sample size of 40 children per group (HST, ShotBlocker, and control) would be sufficient. Considering potential dropouts, the sample size was increased by 10%, and the study was planned to include a total of 132 children who met the inclusion criteria and provided informed consent along with their parents.
Read the detailed description
This randomized controlled experimental study aimed to examine the effects of the Helfer Skin Tap Technique (HST) and ShotBlocker application on pain, emotional responses, and physiological parameters in children aged 7-12 years undergoing intramuscular (IM) drug administration. The study was conducted at the Pediatric Emergency Clinic of Fırat University Hospital between October 1, 2024, and January 31, 2025. The clinic consisted of two observation rooms with 12 beds, where children's medication administration and follow-ups were carried out. The study population included children aged 7-12 years who received Vastus Lateralis IM drug administration (ZOFER® 8mg/4ml Injectable Solution - Ondansetron Hydrochloride Dihydrate) and met the inclusion criteria.
The sample size was determined based on the pain scores from the study by Sivri, Bilgen, and Balcı (2019), with an effect size of d = 0.82 and α = 0.05, indicating that a sample of 40 children per group (HST, ShotBlocker, and control) was sufficient. To account for potential dropouts, the sample size was increased by 10%, resulting in a total of 132 children who met the inclusion criteria and provided informed consent along with their parents.
Participants' pre-test data were collected by the researcher before randomization. To ensure homogeneity, children were stratified based on age, gender, quality of life, and fatigue levels before being assigned to groups using a simple random sampling method. Blinding among researchers was not feasible, and patients in different groups were assigned to different hospital beds. To minimize selection bias, simple randomization was applied. The study protocol was registered in the ClinicalTrials.gov database, supported by the U.S. National Library of Medicine and the National Institutes of Health (NIH). Patients were unaware of their assigned groups (experimental or control).
Data Collection and Measurement Tools
Data were collected using the following tools:
Descriptive Characteristics Form (including age, gender, diagnosis, and history of IM injections).
Physiological Parameters Observation Form, which recorded pre- and post-injection heart rate, respiratory rate, and oxygen saturation using a pulse oximeter.
Faces Pain Scale-Revised (FPS-R), developed by Hicks et al. (2001), a self-reported scale ranging from 0 to 10, with higher scores indicating more severe pain.
Children's Emotional Indicator Scale (CEIS), developed by Li \& Lopez (2005), measuring observable emotional behaviors in five categories (facial expression, vocalization, activity, interaction, and cooperation level), with scores ranging from 5 to 25, where higher scores indicated increased distress. The scale had a Cronbach's alpha value of 0.92 in its original version, while its Turkish adaptation in this study achieved 0.94.
Study Implementation IM injections were administered to children aged 7-12 years with a BMI percentile appropriate for their age. The injections were performed on the Vastus Lateralis muscle using a 16mm or 22mm, 22-25 gauge single-use sterile needle by the same researcher under standard conditions. No local anesthetic or analgesic was applied before the procedure. The research forms were completed before and after the injection by the researcher.
This study provided valuable insights into the effects of skin stimulation techniques on pain perception, emotional distress, and physiological responses in pediatric IM injections, contributing to improved pain management strategies in clinical practice.
- Conditions
- Children
- Being tested
- Helfer skin tap technique, Shotblocker technique
- Keywords
- Intramuscular Injection Pain, Emotional Responses in Children, Helfer Skin Tap Technique, ShotBlocker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helfer skin tap techniqueOther
Also called Helfer skin tap
In the unit where the study was conducted, IM drug administration is performed through the Vastus Lateralis muscle in children aged 7-12 years and with BMI in the appropriate percentile according to age. No anaesthetic etc. application is performed. In order to create similar conditions in the study, children who are requested to be administered IM (ZOFER® 8mg / 4ml Injectable Solution-Ondansetron hydrochloride dihydrate into the Vastus Lateralis) will be included in the study. IM injection will be performed by the same investigator into the Vastus Lateralis muscle of the patient. A 16mm or 22mm, 22-25gauge sterile disposable sterile disposable needle will be used in all patients for injection administration. the procedure will be performed with helfer skin tap technique. Forms will be applied to the children by the researcher before and after IM injection.
Shotblocker techniqueOther
Also called Shotblocker
In the unit where the study was conducted, IM drug administration is performed through the Vastus Lateralis muscle in children aged 7-12 years and with BMI in the appropriate percentile according to age. No anaesthetic etc. application is performed. In order to create similar conditions in the study, children who are requested to be administered IM (ZOFER® 8mg / 4ml Injectable Solution-Ondansetron hydrochloride dihydrate into the Vastus Lateralis) will be included in the study. IM injection will be performed by the same investigator into the Vastus Lateralis muscle of the patient. A 16mm or 22mm, 22-25Gauge sterile disposable sterile disposable needle will be used in all patients. The procedure will be performed using Shotblocker method. Forms will be applied to the children by the investigator before and after IM injection.
| Study group | Role | What they receive |
|---|---|---|
| Helfer Skin Tap Group | Experimental | Helfer Skin Tap Group: The patient will be positioned in the most comfortable way possible. For the injection in the Vastus Lateralis muscle, the patient will be positioned appropriately lying down. After identifying the injection site, the skin will be gently tapped with the palmar surface of the dominant hand's fingers for approximately 5 seconds (about 15 strokes) to relax the muscles. After cleaning the skin with alcohol, the cap of the syringe in the dominant hand will be removed. The non-dominant hand's thumb and index finger will form a large V, and gentle taps will be applied to the skin again. The entire palm of the hand will be used to deliver three firm strokes to the muscle. The strokes (not slaps) should be firm to stimulate the large muscle fibers. After counting to three, the syringe will be inserted into the muscle at a 90° angle simultaneously. Receives: Other: Helfer skin tap technique |
| Shotblocker Group | Experimental | 1. Ensure that the patient takes the most comfortable position possible. For injection into the Vastus Lateralis muscle, the patient will be made to lie in the appropriate position.
2. While removing the cap of the injector needle and holding it between the index and thumb of the active hand, the Shotblocker will be placed appropriately on the injection site with the passive hand, light pressure will be applied.
3. The syringe will be inserted into the tissue smoothly at an angle of 90°. The needle will be prevented from moving in the tissue by holding the ajutage with the thumb and index finger of the passive hand. While holding the Shotblocker with the passive hand, the needle will be prevented from moving in the tissue by holding the ajutage with the thumb and index finger of the passive hand. Aspiration will be performed by pulling the piston back with the active hand.
4. The drug will be injected into the muscle at a rate of 1ml/10sec. Receives: Other: Shotblocker technique |
| control | No intervention | Children included in the control group will be administered IM Zofer drug (the drug will be injected into the muscle at a rate of 1ml/10 sec) with routine standard care of the ward. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Emotional Indicator Scale
The Children's Emotional Indicator Scale (CEIS) was developed by Li and Lopez (2005) to provide a simple, objective and consistent method for nurses to identify children's emotional behaviors during stressful medical procedures. The CSA consists of five categories of observable emotional behaviors (Facial expression, Vocalization, Activity, Interaction and Level of cooperation). Each category has a value between 1-5. The total score that can be obtained from the scale varies between 5-25. The higher the scores obtained from the scale, the higher the negative emotional indicators.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start2 Sep 2024
- Primary completion14 Nov 2024
- Study completion15 Jan 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 Inonu 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
- Crossover
- Model description
- Randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seher ÇEVİK, Inonu University
- Investigators
- Seher Cevik Aktura, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851182
- Sponsor's protocol ID
- Seher C Aktura
- Status last verified
- Feb 2025
- First submitted
- 23 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- 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 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Skin Stimulation Techniques on Intramuscular Injection Pain and Emotional Responses in Children: Helfer Skin Tap Technique and ShotBlocker
- ClinicalTrials.gov ID
- NCT06851182
- Acronym / sponsor ID
- Seher C Aktura
- Conditions
- Children
- Keywords
- Intramuscular Injection Pain, Emotional Responses in Children, Helfer Skin Tap Technique, ShotBlocker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 14 Nov 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 28 Feb 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.
Study Aim: This study aims to determine the effects of the Helfer Skin Tap Technique (HST) and ShotBlocker application on pain, emotional indicators, and physiological parameters during intramuscular (IM) drug administration in children aged 7-12 years.
Study Design This research is designed as a randomized controlled experimental study.
Study Setting and Characteristics The study will be conducted at the Pediatric Emergency Clinic of Fırat University Hospital. The Pediatric Emergency Clinic consists of two observation rooms with a total of 12 beds, where children's medication administration and follow-ups are carried out.
The study population comprises children aged 7-12 years who received Vastus Lateralis IM drug administration (ZOFER® 8mg/4ml Injectable Solution - Ondansetron Hydrochloride Dihydrate) at the Pediatric Emergency Clinic of Fırat University Hospital and met the inclusion criteria during the specified study period.
For sample size estimation, the pain scores from the study by Sivri, Bilgen, and Balcı (2019) were considered. Based on their findings (d = 0.82; α = 0.05), it was determined that a sample size of 40 children per group (HST, ShotBlocker, and control) would be sufficient. Considering potential dropouts, the sample size was increased by 10%, and the study was planned to include a total of 132 children who met the inclusion criteria and provided informed consent along with their parents.
Detailed description
This randomized controlled experimental study aimed to examine the effects of the Helfer Skin Tap Technique (HST) and ShotBlocker application on pain, emotional responses, and physiological parameters in children aged 7-12 years undergoing intramuscular (IM) drug administration. The study was conducted at the Pediatric Emergency Clinic of Fırat University Hospital between October 1, 2024, and January 31, 2025. The clinic consisted of two observation rooms with 12 beds, where children's medication administration and follow-ups were carried out. The study population included children aged 7-12 years who received Vastus Lateralis IM drug administration (ZOFER® 8mg/4ml Injectable Solution - Ondansetron Hydrochloride Dihydrate) and met the inclusion criteria.
The sample size was determined based on the pain scores from the study by Sivri, Bilgen, and Balcı (2019), with an effect size of d = 0.82 and α = 0.05, indicating that a sample of 40 children per group (HST, ShotBlocker, and control) was sufficient. To account for potential dropouts, the sample size was increased by 10%, resulting in a total of 132 children who met the inclusion criteria and provided informed consent along with their parents.
Participants' pre-test data were collected by the researcher before randomization. To ensure homogeneity, children were stratified based on age, gender, quality of life, and fatigue levels before being assigned to groups using a simple random sampling method. Blinding among researchers was not feasible, and patients in different groups were assigned to different hospital beds. To minimize selection bias, simple randomization was applied. The study protocol was registered in the ClinicalTrials.gov database, supported by the U.S. National Library of Medicine and the National Institutes of Health (NIH). Patients were unaware of their assigned groups (experimental or control).
Data Collection and Measurement Tools
Data were collected using the following tools:
Descriptive Characteristics Form (including age, gender, diagnosis, and history of IM injections).
Physiological Parameters Observation Form, which recorded pre- and post-injection heart rate, respiratory rate, and oxygen saturation using a pulse oximeter.
Faces Pain Scale-Revised (FPS-R), developed by Hicks et al. (2001), a self-reported scale ranging from 0 to 10, with higher scores indicating more severe pain.
Children's Emotional Indicator Scale (CEIS), developed by Li \& Lopez (2005), measuring observable emotional behaviors in five categories (facial expression, vocalization, activity, interaction, and cooperation level), with scores ranging from 5 to 25, where higher scores indicated increased distress. The scale had a Cronbach's alpha value of 0.92 in its original version, while its Turkish adaptation in this study achieved 0.94.
Study Implementation IM injections were administered to children aged 7-12 years with a BMI percentile appropriate for their age. The injections were performed on the Vastus Lateralis muscle using a 16mm or 22mm, 22-25 gauge single-use sterile needle by the same researcher under standard conditions. No local anesthetic or analgesic was applied before the procedure. The research forms were completed before and after the injection by the researcher.
This study provided valuable insights into the effects of skin stimulation techniques on pain perception, emotional distress, and physiological responses in pediatric IM injections, contributing to improved pain management strategies in clinical practice.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Helfer Skin Tap Group | Experimental | Other: Helfer skin tap techniqueHelfer Skin Tap Group: The patient will be positioned in the most comfortable way possible. For the injection in the Vastus Lateralis muscle, the patient will be positioned appropriately lying down. After identifying the injection site, the skin will be gently tapped with the palmar surface of the dominant hand's fingers for approximately 5 seconds (about 15 strokes) to relax the muscles. After cleaning the skin with alcohol, the cap of the syringe in the dominant hand will be removed. The non-dominant hand's thumb and index finger will form a large V, and gentle taps will be applied to the skin again. The entire palm of the hand will be used to deliver three firm strokes to the muscle. The strokes (not slaps) should be firm to stimulate the large muscle fibers. After counting to three, the syringe will be inserted into the muscle at a 90° angle simultaneously. |
| Shotblocker Group | Experimental | Other: Shotblocker technique1. Ensure that the patient takes the most comfortable position possible. For injection into the Vastus Lateralis muscle, the patient will be made to lie in the appropriate position. 2. While removing the cap of the injector needle and holding it between the index and thumb of the active hand, the Shotblocker will be placed appropriately on the injection site with the passive hand, light pressure will be applied. 3. The syringe will be inserted into the tissue smoothly at an angle of 90°. The needle will be prevented from moving in the tissue by holding the ajutage with the thumb and index finger of the passive hand. While holding the Shotblocker with the passive hand, the needle will be prevented from moving in the tissue by holding the ajutage with the thumb and index finger of the passive hand. Aspiration will be performed by pulling the piston back with the active hand. 4. The drug will be injected into the muscle at a rate of 1ml/10sec. |
| control | No intervention | –Children included in the control group will be administered IM Zofer drug (the drug will be injected into the muscle at a rate of 1ml/10 sec) with routine standard care of the ward. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- - 7 to 12 years old,
- BMI level in the appropriate range according to age,
- IM drug administered to the Vastus Lateralis muscle,
- No disease that causes chronic pain,
- Not taking any analgesic medication in the last 8 hours before the procedure,
Key exclusion criteria (3 listed)
- - BMI level is not in the appropriate range according to age,
- Forms with incomplete or incorrect answers,
- Children who did not volunteer to participate in the study were excluded from the study.
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 |
|---|---|---|
| Helfer skin tap techniqueAlso: Helfer skin tapIn the unit where the study was conducted, IM drug administration is performed through the Vastus Lateralis muscle in children aged 7-12 years and with BMI in the appropriate percentile according to age. No anaesthetic etc. application is performed. In order to create similar conditions in the study, children who are requested to be administered IM (ZOFER® 8mg / 4ml Injectable Solution-Ondansetron hydrochloride dihydrate into the Vastus Lateralis) will be included in the study. IM injection will be performed by the same investigator into the Vastus Lateralis muscle of the patient. A 16mm or 22mm, 22-25gauge sterile disposable sterile disposable needle will be used in all patients for injection administration. the procedure will be performed with helfer skin tap technique. Forms will be applied to the children by the researcher before and after IM injection. | Other | Helfer Skin Tap Group |
| Shotblocker techniqueAlso: ShotblockerIn the unit where the study was conducted, IM drug administration is performed through the Vastus Lateralis muscle in children aged 7-12 years and with BMI in the appropriate percentile according to age. No anaesthetic etc. application is performed. In order to create similar conditions in the study, children who are requested to be administered IM (ZOFER® 8mg / 4ml Injectable Solution-Ondansetron hydrochloride dihydrate into the Vastus Lateralis) will be included in the study. IM injection will be performed by the same investigator into the Vastus Lateralis muscle of the patient. A 16mm or 22mm, 22-25Gauge sterile disposable sterile disposable needle will be used in all patients. The procedure will be performed using Shotblocker method. Forms will be applied to the children by the investigator before and after IM injection. | Other | Shotblocker Group |
Primary outcome
Children's Emotional Indicator Scale
Time frame: 1 month
The Children's Emotional Indicator Scale (CEIS) was developed by Li and Lopez (2005) to provide a simple, objective and consistent method for nurses to identify children's emotional behaviors during stressful medical procedures. The CSA consists of five categories of observable emotional behaviors (Facial expression, Vocalization, Activity, Interaction and Level of cooperation). Each category has a value between 1-5. The total score that can be obtained from the scale varies between 5-25. The higher the scores obtained from the scale, the higher the negative emotional indicators.
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 28 Feb 2025.
- 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.
Seher Cevik Aktura principal investigator
Inonu 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 Helfer skin tap technique and Shotblocker technique in people with Children, run by Inonu 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 9 inclusion and 3 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 28 Feb 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?
Children's Emotional Indicator Scale (time frame: 1 month). 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 28 Feb 2025.