PainNCT06762938
The Effect of ShotBlocker on Pain and Satisfaction During Measles-Rubella-Mumps Vaccination
A study testing ShotBlocker in people with Pain, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
Objective The aim of this study was to evaluate the effects of ShotBlocker administration during measles-mumps-rubella (MMR) vaccination on infants' pain level and mothers' satisfaction. Method. Read more about this study
- Who is it for?
- Ages 12 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- ShotBlocker
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 30 Nov 2024
- 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 12 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- He's 12 months old,
- MMR vaccine will be administered,
- growth-development is normal,
- no analgesic medication was given during the day,
- at least high school graduate
- mothers who volunteered to participate in the study
Who cannot join
- Neurological disease,
- a chronic disease,
- allergy (egg allergy)
- infants with symptoms of hyperthermia
Trial locations and contacts
1 site in 1 country.
About this study
Objective The aim of this study was to evaluate the effects of ShotBlocker administration during measles-mumps-rubella (MMR) vaccination on infants' pain level and mothers' satisfaction.
Method. The study was conducted in a Family Health Center affiliated to the Public Health Directorate of a province in eastern Turkey between August and October 2024 using a randomized controlled experimental design. The study sample consisted of 60 infants who received MMR vaccination (ShotBlocker group: n = 30, control group: n = 30). Infants in the ShotBlocker group received ShotBlocker before vaccine injection, while infants in the control group received only routine vaccine injection. Infant information form, FLACC pain scale and Newcastle Satisfaction with Nursing Care Scale were used for data collection. Ethical principles were followed throughout the study.
- Conditions
- Pain
- Being tested
- ShotBlocker
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShotBlockerBehavioural
Apply ShotBlocker
| Study group | Role | What they receive |
|---|---|---|
| ShotBlocker | Experimental | Not described Receives: Behavioral: ShotBlocker |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Face, Legs, Activity, Crying, Consolability Pain Scala
min-max (0-10), lower score means better result, reduce scale scores
Measured: pre-test post-test (approximately three months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start1 Aug 2024
- Primary completion20 Nov 2024
- Study completion30 Nov 2024
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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veysel Can, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762938
- Sponsor's protocol ID
- ShotBlocker
- Status last verified
- Jan 2025
- First submitted
- 31 Dec 2024
- Last updated
- 8 Jan 2025
- Results posted
- 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 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of ShotBlocker on Pain and Satisfaction During Measles-Rubella-Mumps Vaccination
- ClinicalTrials.gov ID
- NCT06762938
- Acronym / sponsor ID
- ShotBlocker
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 8 Jan 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.
Objective The aim of this study was to evaluate the effects of ShotBlocker administration during measles-mumps-rubella (MMR) vaccination on infants' pain level and mothers' satisfaction.
Method. The study was conducted in a Family Health Center affiliated to the Public Health Directorate of a province in eastern Turkey between August and October 2024 using a randomized controlled experimental design. The study sample consisted of 60 infants who received MMR vaccination (ShotBlocker group: n = 30, control group: n = 30). Infants in the ShotBlocker group received ShotBlocker before vaccine injection, while infants in the control group received only routine vaccine injection. Infant information form, FLACC pain scale and Newcastle Satisfaction with Nursing Care Scale were used for data collection. Ethical principles were followed throughout the study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ShotBlocker | Experimental | Behavioral: ShotBlocker |
| Control | No intervention | – |
Who may qualify
- Ages
- 12 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- He's 12 months old,
- MMR vaccine will be administered,
- growth-development is normal,
- no analgesic medication was given during the day,
- at least high school graduate
Key exclusion criteria (4 listed)
- Neurological disease,
- a chronic disease,
- allergy (egg allergy)
- infants with symptoms of hyperthermia
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 |
|---|---|---|
| ShotBlockerApply ShotBlocker | Behavioural | ShotBlocker |
Primary outcome
Face, Legs, Activity, Crying, Consolability Pain Scala
Time frame: pre-test post-test (approximately three months)
min-max (0-10), lower score means better result, reduce scale scores
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 8 Jan 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.
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 in people with Pain, run by Yuzuncu Yil 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 6 inclusion and 4 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 8 Jan 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?
Face, Legs, Activity, Crying, Consolability Pain Scala (time frame: pre-test post-test (approximately three months)). 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 8 Jan 2025.