Patients Above 18 YearsNCT06624761
Effect of Shotblocker in Reducing Intramuscular Injection Pain in Adult Patients
A study testing ShotBlocker in people with Patients Above 18 Years, run by Yağmur SÜRMELİ AKBAL at 1 site in Turkey (Türkiye).
Trial summary
This randomized, double-blind study aimed to determine the effect of ShotBlocker on IMI pain in adult patients who received diclofenac sodium and metamizole sodium as IMI in the emergency department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Above 18 Years
- What is being tested?
- ShotBlocker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Oct 2024to 1 Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 and over who speak Turkish,
- Who have signed the informed consent form,
- Who are admitted to the emergency room for prescription drug use or who are planned to use diclofenac sodium and metamizole sodium as IMI upon the directive of the emergency room physician will constitute.
Who cannot join
- Pregnant women,
- Those with psychiatric disorders,
- Those with hearing or vision problems,
- Those who applied to the red area of the emergency room,
- Those with impaired consciousness,
- Those with secondary injuries and infections at the injection site,
- Those who have previously received an injection at the same site within the last 24 hours, -Those who did not sign the informed consent form for the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Toros State Hospital
Mersin, Adana, Mersin, 33110
About this study
Official title: Determination of the Effect of Shotblocker in Reducing Intramuscular Injection Pain in Adult Patients: A Randomized Controlled Trial
This randomized, double-blind study aimed to determine the effect of ShotBlocker on IMI pain in adult patients who received diclofenac sodium and metamizole sodium as IMI in the emergency department. The main question(s) it aims to answer are as follows:
- [Is there a difference between the pain score averages between the intervention group and the control group after ShotBlocker? Participants [Participants in both groups are individuals who applied to the emergency department and received IM injections according to the doctor\'s order.] If there is a comparison group: Researchers will make a comparison with the control group.
Read the detailed description
The study is planned to be conducted between October 2024 and December 2024. The population of the study will consist of adult patients who have applied to the emergency department of a state hospital in Turkey between October 2024 and December 2024 due to the use of previously prescribed drugs (diclofenac sodium and metamizole sodium) or who need to be administered IMI diclofenac sodium and metamizole sodium upon the order of the emergency room physician. The minimum sample size expected to complete the data collection form of the study was calculated with G power analysis at a 95% confidence level before the data collection phase. Accordingly, the sample size required for the study was determined as 25 for each group, with an alpha value of 0.01, an effect size of 1.583, and a theoretical power of 99% [23]. In case of sample loss during the study, it was planned to take 20% more samples than the calculated sample and to include 30 people in each group (with and without ShotBlocker).
As data collection tools; Personal and Applied Drug Information Form and Visual Analog Scale will be used. Personal Information Form will consist of 8 questions in total, 7 of which include the patients' introductory characteristics (age, gender, height, weight, fear of injection) and 1 question including the name of the drug. In addition to this form, Visual Analog Scale (VAS) is used to measure the pain perceived by the person. In this scale, the person can indicate his/her own pain by drawing a line, putting a dot or pointing between the part where there is no pain (zero) on one end of the ruler and the part where there is the most severe pain (10 cm) on the other end. The distance from the point where there is no pain to the point marked by the person is measured in centimeters and the value found indicates the person's pain intensity. In the VAS scale, 0-44 mm reflects mild pain, 45-74 mm reflects moderate pain and 75-100 mm reflects severe pain.
Research Application Procedure Step 1: Before starting the application, a preliminary interview will be conducted with practitioners who are not included in the study and who work as nurses in the emergency department. Information will be provided about the purpose of the study and the scale to be used. It will also be stated that these forms will be filled out by patients who received diclofenac sodium and metamizole sodium as IMI from the ventrogluteal region, used ShotBlocker during this period and met the research criteria.
Step 2: VAS will be applied to the patients immediately after the application. Step 3: VAS will also be applied to patients in the control group who received diclofenac sodium and metamizole sodium as IMI from the ventrogluteal region, did not use ShotBlocker during this period and met the research criteria.
- Conditions
- Patients Above 18 Years
- Being tested
- ShotBlocker
- Keywords
- ShotBlocker, intramuscular injection pain, nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShotBlockerDevice
A randomized study investigating ShotBlocker in painkillers containing different active ingredients could not be found.
| Study group | Role | What they receive |
|---|---|---|
| ShotBlocker | Experimental | ShotBlocker will be applied to the experimental group. Receives: Device: ShotBlocker |
| Control group | No intervention | no intervention will be made |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is used to measure the pain perceived by the person. In this scale, the individual can indicate their own pain by drawing a line, putting a dot, or pointing between the 10 cm (100 mm) section of the ruler where there is no pain (zero) on one end and the most severe pain on the other end. The distance from the point where there is no pain to the point marked by the individual is measured in centimeters and the value found indicates the individual\'s pain intensity. On the VAS scale, 0-44 mm indicates mild pain, 45-74 mm indicates moderate pain, and 75-100 mm reflects severe pain.
Measured: 12 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start14 Oct 2024
- Primary completion30 Dec 2024
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Above 18 YearsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be 2 groups (ShotBlocker and control )
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yağmur SÜRMELİ AKBAL
- Sponsor type
- University, hospital or other
- Collaborators
- Toros University
- Responsible party
- Sponsor-investigator, Yağmur SÜRMELİ AKBAL, Mersin University
- Investigators
- YAGMUR SÜRMELI, DR., Study director, Toros University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624761
- Sponsor's protocol ID
- E-79438647-108-48697 TU
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2024
- Last updated
- 22 Oct 2026
- 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 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Effect of Shotblocker in Reducing Intramuscular Injection Pain in Adult Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06624761
- Acronym / sponsor ID
- E-79438647-108-48697 TU
- Conditions
- Patients Above 18 Years
- Keywords
- ShotBlocker, intramuscular injection pain, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yağmur SÜRMELİ AKBALUniversity, hospital or other
- Collaborators
- Toros University
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 3 Oct 2024 (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.
This randomized, double-blind study aimed to determine the effect of ShotBlocker on IMI pain in adult patients who received diclofenac sodium and metamizole sodium as IMI in the emergency department. The main question(s) it aims to answer are as follows:
- [Is there a difference between the pain score averages between the intervention group and the control group after ShotBlocker? Participants [Participants in both groups are individuals who applied to the emergency department and received IM injections according to the doctor\'s order.] If there is a comparison group: Researchers will make a comparison with the control group.
Detailed description
The study is planned to be conducted between October 2024 and December 2024. The population of the study will consist of adult patients who have applied to the emergency department of a state hospital in Turkey between October 2024 and December 2024 due to the use of previously prescribed drugs (diclofenac sodium and metamizole sodium) or who need to be administered IMI diclofenac sodium and metamizole sodium upon the order of the emergency room physician. The minimum sample size expected to complete the data collection form of the study was calculated with G power analysis at a 95% confidence level before the data collection phase. Accordingly, the sample size required for the study was determined as 25 for each group, with an alpha value of 0.01, an effect size of 1.583, and a theoretical power of 99% [23]. In case of sample loss during the study, it was planned to take 20% more samples than the calculated sample and to include 30 people in each group (with and without ShotBlocker).
As data collection tools; Personal and Applied Drug Information Form and Visual Analog Scale will be used. Personal Information Form will consist of 8 questions in total, 7 of which include the patients' introductory characteristics (age, gender, height, weight, fear of injection) and 1 question including the name of the drug. In addition to this form, Visual Analog Scale (VAS) is used to measure the pain perceived by the person. In this scale, the person can indicate his/her own pain by drawing a line, putting a dot or pointing between the part where there is no pain (zero) on one end of the ruler and the part where there is the most severe pain (10 cm) on the other end. The distance from the point where there is no pain to the point marked by the person is measured in centimeters and the value found indicates the person's pain intensity. In the VAS scale, 0-44 mm reflects mild pain, 45-74 mm reflects moderate pain and 75-100 mm reflects severe pain.
Research Application Procedure Step 1: Before starting the application, a preliminary interview will be conducted with practitioners who are not included in the study and who work as nurses in the emergency department. Information will be provided about the purpose of the study and the scale to be used. It will also be stated that these forms will be filled out by patients who received diclofenac sodium and metamizole sodium as IMI from the ventrogluteal region, used ShotBlocker during this period and met the research criteria.
Step 2: VAS will be applied to the patients immediately after the application. Step 3: VAS will also be applied to patients in the control group who received diclofenac sodium and metamizole sodium as IMI from the ventrogluteal region, did not use ShotBlocker during this period and met the research criteria.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- There will be 2 groups (ShotBlocker and control )
| Arm | Type | Receives |
|---|---|---|
| ShotBlocker | Experimental | Device: ShotBlockerShotBlocker will be applied to the experimental group. |
| Control group | No intervention | –no intervention will be made |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 and over who speak Turkish,
- Who have signed the informed consent form,
- Who are admitted to the emergency room for prescription drug use or who are planned to use diclofenac sodium and metamizole sodium as IMI upon the directive of the emergency room physician will constitute.
Key exclusion criteria (7 listed)
- Pregnant women,
- Those with psychiatric disorders,
- Those with hearing or vision problems,
- Those who applied to the red area of the emergency room,
- Those with impaired consciousness,
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 |
|---|---|---|
| ShotBlockerA randomized study investigating ShotBlocker in painkillers containing different active ingredients could not be found. | Device | ShotBlocker |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 12 week.
The Visual Analog Scale (VAS) is used to measure the pain perceived by the person. In this scale, the individual can indicate their own pain by drawing a line, putting a dot, or pointing between the 10 cm (100 mm) section of the ruler where there is no pain (zero) on one end and the most severe pain on the other end. The distance from the point where there is no pain to the point marked by the individual is measured in centimeters and the value found indicates the individual\'s pain intensity. On the VAS scale, 0-44 mm indicates mild pain, 45-74 mm indicates moderate pain, and 75-100 mm reflects severe 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 22 Oct 2026.
- 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.
YAGMUR SÜRMELI, DR. study director
Toros 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 ShotBlocker in people with Patients Above 18 Years, run by Yağmur SÜRMELİ AKBAL 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 3 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 22 Oct 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?
Visual Analog Scale (VAS) (time frame: 12 week.). 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 22 Oct 2026.