Healthy VolunteersPhase 4NCT06813729
Effects of Shotblocker® and Manual Pressure on Pain
A Phase 4 study testing Shotblocker and Manuel Pressure in people with Healthy Volunteers and Infant, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
Aim This randomized controlled experimental study was conducted to determine the effect of ShotBlocker® and manual pressure application on pain in the application of Conjugated Pneumococcal Vaccine (PCV). Read more about this study
- Who is it for?
- Ages 4 to 4 months
- Conditions the study is for
- Healthy Volunteers, Infant, Vaccine
- What is being tested?
- Shotblocker and Manuel Pressure
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2022to 15 Nov 2023
- Phase
- Phase 4
- 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 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infant who were 4 months old
- who receive the pneumococcal conjugate vaccine receive
- healthly infant, free from systemic illnesses
- accompanied by their mothers
- attending the center for routine vaccination
Who cannot join
- who have serious congenital malformations
- who have neurodevelopmental delays
- who have serious congenital malformations
- who have febrile conditions
- who have a history of circulatory or peripheral vascular issues
- who had taken sedatives, hypnotics, or systemic pain relievers within the last 6 hours
- infant who cried before receiving the vaccine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Shotblocker® and Manual Pressure on Pain During the Administration of Vaccine in Infants
Aim This randomized controlled experimental study was conducted to determine the effect of ShotBlocker® and manual pressure application on pain in the application of Conjugated Pneumococcal Vaccine (PCV).
The following hypotheses were determined for the study; Hypothesis 1: Pain scores of infants are lower in the manual pressure group than in the control group during the administration of PCV.
Hypothesis 2: Pain scores of infants are lower in Shotblocker® group than in the control group during the administration of PCV.
Hypothesis 3: Manual pressure is more effective than Shotblocker® in infants to reducing pain during the administration of PCV.
Read the detailed description
The study was carried out at three family health centers, all with the same nurse administering care. Infant who were 4 months old and scheduled to receive the PCV vaccine were eligible for participation. The data were collected using a questionnaire form and the Neonatal Infant Pain Scale (NIPS).
A standard procedure was followed for all infants, which included bringing the infant and mothers into the vaccination room, providing information about the vaccine, introducing the researcher, and obtaining informed consent. Infants were assigned to groups based on randomization. To control factors related to the application process (such as injection technique and communication approach), vaccines were administered by same experienced nurse working at the family center where the research was conducted.
A video camera with a 5X optical zoom support (Samsung M51 brand smartphone) was used to record vaccine injections. It was placed on a tripod across the stretcher where the infants were vaccinated. Each infant was recorded for during vaccination, and 2 min after vaccination.
Written approval was obtained from the Ethics Committee (2021/279) and institution where the study was conducted (E-79593712-605.99). The nurse researcher informed infants' mothers about the study. Upon agreement from mothers, written consent forms were obtained.
Data were analyzed using SPSS for Windows version 25.0 (IBM, Armonk, NY). Numeric variables are presented as counts, percentages, means, standard deviations, and min-max values. The assumption of normal distribution was checked with the Shapiro-Wilk test, and the assumption of homogeneity of variances was controlled with the Levene test. To compare pain scores after vaccination, a paired sample t-test was used. In cases where the data showed a normal distribution and there were more than two independent groups, a one-way analysis of variance (ANOVA) test was employed. A significance level of p < .05 was considered statistically significant.
- Conditions
- Healthy Volunteers, Infant, Vaccine, Pain
- Being tested
- Shotblocker, Manuel Pressure
- Keywords
- pain, vaccine, shotblocker, manuel pressure, infant
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShotblockerBiological
The infant was first placed on the examination table. To calm the infant, the mother was asked to hold the infants' hands and talk to him/her. Before the injection, while one nurse held the infants' leg for the injection, Shotblocker® was applied to the skin by the experienced nurse ensuring that the points were in direct contact. Then, the nurse administered the pneumococcal conjugate vaccine (0.5 ml, IM, Vastus Lateralis Site) through the central hole. After each use, the Shotblocker® was disinfected with 70% alcohol before being used on another infant.
Manuel PressureBiological
The infant was first placed on the examination table. To calm the infant, the mother was asked to hold the infants' hands and talk to him/her. Next, while one nurse held the infants' leg for the injection, 10-second manual pressure was applied on the vaccine injection site by the experienced nurse. Then pneumococcal conjugate vaccine was administered in accordance with the standard injection technique (0.5 ml, IM, Vastus Lateralis Site).
| Study group | Role | What they receive |
|---|---|---|
| The Shotblocker® Group | Experimental | Shotblocker® is a small, flexible plastic device designed to be drug-free, featuring multiple rounded points on the bottom that come into contact with the skin. It also has a central hole for injection administration. Receives: Biological: Shotblocker |
| The Manuel Pressure Group | Experimental | nurse held the infants' leg for the injection, 10-second manual pressure was applied on the vaccine injection site by the experienced nurse before pneumococcal conjugate vaccine Receives: Biological: Manuel Pressure |
| The Control Group | No intervention | The infant was first placed on the examination table. To calm the infant, the mother was asked to hold the infants' hands and talk to him/her. Distraction method was not employed for the infants in this group, and while one nurse held the infants' leg for the injection, the experienced nurse administered the pneumococcal conjugate vaccine (0.5 ml, IM, Vastus Lateralis Site). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain mean score
The Neonatal Infant Pain Scale total mean score of infants are lower in the manual pressure and shotbocker groups than in the control group during the administration of PCV.
Measured: immediately after the pneumococcal conjugate vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start15 Feb 2022
- Primary completion15 Jun 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nihal Taskiran, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813729
- Sponsor's protocol ID
- E-79593712-605.99
- Status last verified
- Feb 2025
- First submitted
- 29 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kislali Tas S, Sari D, Taskiran N. Reducing Vaccination Pain in Infants: A Randomized Controlled Trial on the Effects of ShotBlocker and Manual Pressure. Clin Pediatr (Phila). 2026 Mar;65(3):317-325. doi: 10.1177/00099228251387875. Epub 2025 Oct 29.
PubMed 41159533
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Shotblocker® and Manual Pressure on Pain During the Administration of Vaccine in Infants
- ClinicalTrials.gov ID
- NCT06813729
- Acronym / sponsor ID
- E-79593712-605.99
- Conditions
- Healthy Volunteers, Infant, Vaccine, Pain
- Keywords
- pain, vaccine, shotblocker, manuel pressure, infant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 7 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.
Aim This randomized controlled experimental study was conducted to determine the effect of ShotBlocker® and manual pressure application on pain in the application of Conjugated Pneumococcal Vaccine (PCV).
The following hypotheses were determined for the study; Hypothesis 1: Pain scores of infants are lower in the manual pressure group than in the control group during the administration of PCV.
Hypothesis 2: Pain scores of infants are lower in Shotblocker® group than in the control group during the administration of PCV.
Hypothesis 3: Manual pressure is more effective than Shotblocker® in infants to reducing pain during the administration of PCV.
Detailed description
The study was carried out at three family health centers, all with the same nurse administering care. Infant who were 4 months old and scheduled to receive the PCV vaccine were eligible for participation. The data were collected using a questionnaire form and the Neonatal Infant Pain Scale (NIPS).
A standard procedure was followed for all infants, which included bringing the infant and mothers into the vaccination room, providing information about the vaccine, introducing the researcher, and obtaining informed consent. Infants were assigned to groups based on randomization. To control factors related to the application process (such as injection technique and communication approach), vaccines were administered by same experienced nurse working at the family center where the research was conducted.
A video camera with a 5X optical zoom support (Samsung M51 brand smartphone) was used to record vaccine injections. It was placed on a tripod across the stretcher where the infants were vaccinated. Each infant was recorded for during vaccination, and 2 min after vaccination.
Written approval was obtained from the Ethics Committee (2021/279) and institution where the study was conducted (E-79593712-605.99). The nurse researcher informed infants' mothers about the study. Upon agreement from mothers, written consent forms were obtained.
Data were analyzed using SPSS for Windows version 25.0 (IBM, Armonk, NY). Numeric variables are presented as counts, percentages, means, standard deviations, and min-max values. The assumption of normal distribution was checked with the Shapiro-Wilk test, and the assumption of homogeneity of variances was controlled with the Levene test. To compare pain scores after vaccination, a paired sample t-test was used. In cases where the data showed a normal distribution and there were more than two independent groups, a one-way analysis of variance (ANOVA) test was employed. A significance level of p < .05 was considered statistically significant.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- A Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| The Shotblocker® Group | Experimental | Biological: ShotblockerShotblocker® is a small, flexible plastic device designed to be drug-free, featuring multiple rounded points on the bottom that come into contact with the skin. It also has a central hole for injection administration. |
| The Manuel Pressure Group | Experimental | Biological: Manuel Pressurenurse held the infants' leg for the injection, 10-second manual pressure was applied on the vaccine injection site by the experienced nurse before pneumococcal conjugate vaccine |
| The Control Group | No intervention | –The infant was first placed on the examination table. To calm the infant, the mother was asked to hold the infants' hands and talk to him/her. Distraction method was not employed for the infants in this group, and while one nurse held the infants' leg for the injection, the experienced nurse administered the pneumococcal conjugate vaccine (0.5 ml, IM, Vastus Lateralis Site). |
Who may qualify
- Ages
- 4 to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Infant who were 4 months old
- who receive the pneumococcal conjugate vaccine receive
- healthly infant, free from systemic illnesses
- accompanied by their mothers
- attending the center for routine vaccination
Key exclusion criteria (7 listed)
- who have serious congenital malformations
- who have neurodevelopmental delays
- who have serious congenital malformations
- who have febrile conditions
- who have a history of circulatory or peripheral vascular issues
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 |
|---|---|---|
| ShotblockerThe infant was first placed on the examination table. To calm the infant, the mother was asked to hold the infants' hands and talk to him/her. Before the injection, while one nurse held the infants' leg for the injection, Shotblocker® was applied to the skin by the experienced nurse ensuring that the points were in direct contact. Then, the nurse administered the pneumococcal conjugate vaccine (0.5 ml, IM, Vastus Lateralis Site) through the central hole. After each use, the Shotblocker® was disinfected with 70% alcohol before being used on another infant. | Biological | The Shotblocker® Group |
| Manuel PressureThe infant was first placed on the examination table. To calm the infant, the mother was asked to hold the infants' hands and talk to him/her. Next, while one nurse held the infants' leg for the injection, 10-second manual pressure was applied on the vaccine injection site by the experienced nurse. Then pneumococcal conjugate vaccine was administered in accordance with the standard injection technique (0.5 ml, IM, Vastus Lateralis Site). | Biological | The Manuel Pressure Group |
Primary outcome
Pain mean score
Time frame: immediately after the pneumococcal conjugate vaccination
The Neonatal Infant Pain Scale total mean score of infants are lower in the manual pressure and shotbocker groups than in the control group during the administration of PCV.
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 7 Feb 2025.
- Derived from this study: PubMed 41159533Kislali Tas S, Sari D, Taskiran N. Reducing Vaccination Pain in Infants: A Randomized Controlled Trial on the Effects of ShotBlocker and Manual Pressure. Clin Pediatr (Phila). 2026 Mar;65(3):317-325. doi: 10.1177/00099228251387875. Epub 2025 Oct 29.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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 Phase 4 study testing Shotblocker and Manuel Pressure in people with Healthy Volunteers and Infant, run by Aydin Adnan Menderes 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 5 inclusion and 7 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 7 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 mean score (time frame: immediately after the pneumococcal conjugate vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06813729, which also lists 1 linked publication.
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 7 Feb 2025.