Acute PainSB-PIVCNCT07553624
The Effect of ShotBlocker on Pain, Anxiety, and Satisfaction During Peripheral Intravenous Catheterization
A study testing ShotBlocker in people with Acute Pain and Anxiety, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to evaluate the effect of the ShotBlocker device on pain, anxiety, and patient satisfaction during peripheral intravenous catheterization (PIVC). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Pain, Anxiety
- What is being tested?
- ShotBlocker
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Apr 2026to 29 May 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals aged 18 years and older Patients requiring peripheral intravenous catheterization Patients who are conscious and able to communicate Patients who agree to participate in the study and provide informed consent
Who cannot join
- Patients with cognitive impairment or inability to communicate Patients with a history of chronic pain or current use of analgesics Patients with dermatological conditions or wounds at the catheterization site Patients who previously experienced peripheral intravenous catheterization within the last 24 hours Patients who refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Shotblocker on Pain, Anxiety, and Satisfaction During Peripheral Intravenous Catheterization: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effect of the ShotBlocker device on pain, anxiety, and patient satisfaction during peripheral intravenous catheterization (PIVC). Peripheral intravenous catheterization is a commonly performed procedure in clinical settings and is often associated with pain and anxiety, which may negatively affect patient experience.
The ShotBlocker is a simple, non-pharmacological device designed to reduce pain by applying pressure and sensory stimulation at the injection site. Participants will be randomly assigned to either the intervention group, where the ShotBlocker will be used during the procedure, or the control group, where routine care will be provided.Pain will be assessed using the Visual Analog Scale (VAS). Anxiety and patient satisfaction will be evaluated using a visual analog-based scale supported , combining features of the Visual Analog Scale and the Wong-Baker Faces Scale, with scores ranging from 0 to 10. The findings of this study are expected to contribute to evidence-based nursing practices by providing an effective, low-cost, and non-invasive method for reducing procedural discomfort and improving patient experience during PIVC.
Read the detailed description
Peripheral intravenous catheterization (PIVC) is one of the most frequently performed invasive procedures in clinical practice. Despite its routine nature, it is commonly associated with pain and anxiety, which may negatively influence patient comfort, satisfaction, and overall experience of care. Therefore, effective and practical strategies to reduce procedure-related discomfort are essential in nursing practice.
The ShotBlocker is a simple, non-pharmacological device designed to reduce pain by applying mechanical pressure and providing sensory distraction at the injection site. It is inexpensive, easy to use, and does not require additional training or pharmacological intervention, making it suitable for routine clinical use.
This study is designed as a randomized controlled trial to evaluate the effectiveness of the ShotBlocker device during PIVC. Participants will be randomly assigned to either the intervention group, in which the ShotBlocker will be applied during the catheterization procedure, or the control group, in which routine care will be provided without any additional intervention.
Pain intensity will be assessed using the Visual Analog Scale (VAS). Anxiety and patient satisfaction will be evaluated using a visual analog-based scale supported by combining features of the Visual Analog Scale and the Wong-Baker Faces Scale, with scores ranging from 0 to 10.
All procedures will be performed by trained healthcare professionals following standard clinical protocols. Data will be collected immediately after the procedure. The primary outcome of the study is pain intensity, while secondary outcomes include anxiety and patient satisfaction.
The results of this study are expected to provide evidence for the effectiveness of a simple, non-invasive, and cost-effective method to reduce procedure-related discomfort and improve patient-centered care in clinical settings.
- Conditions
- Acute Pain, Anxiety
- Being tested
- ShotBlocker
- Keywords
- Peripheral Intravenous Catheterization, ShotBlocker, Pain, Anxiety, Patient Satisfaction
- Medical subject headings
- Acute Pain, Anxiety Disorders, Pain, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShotBlockerDevice
A non-pharmacological device applied to the skin to reduce pain through mechanical pressure and sensory stimulation during peripheral intravenous catheterization.
| Study group | Role | What they receive |
|---|---|---|
| ShotBlocker Group | Experimental | Participants will receive peripheral intravenous catheterization using the ShotBlocker device during the procedure. Receives: Device: ShotBlocker |
| Control Group | No intervention | Participants will receive routine peripheral intravenous catheterization without the use of the ShotBlocker device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity During Peripheral Intravenous Catheterization
Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain).
Measured: Immediately after the procedure
Secondary outcomes (2)
Anxiety Level
Anxiety will be assessed using a visual analog scale with scores ranging from 0 to 10, both before and immediately after the procedure.
Measured: Before and immediately after the procedure
Patient Satisfaction
Patient satisfaction will be assessed immediately after the procedure using a visual analog-based scale supported by , with scores ranging from 0 to 10.
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start18 Apr 2026
- Primary completion29 May 2026
- Study completion29 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either the intervention group (ShotBlocker) or the control group (routine care) in a parallel design.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Kayseri City Hospital
- Responsible party
- Principal investigator, Emine Korkmaz, Kirsehir Ahi Evran Universitesi
- Investigators
- Emine Korkmaz, PhD, Principal investigator, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553624
- Sponsor's protocol ID
- SB-PIVC-01
- Acronym
- SB-PIVC
- Status last verified
- Oct 2026
- First submitted
- 17 Apr 2026
- Last updated
- 30 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Shotblocker on Pain, Anxiety, and Satisfaction During Peripheral Intravenous Catheterization: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07553624
- Acronym / sponsor ID
- SB-PIVC / SB-PIVC-01
- Conditions
- Acute Pain, Anxiety
- Keywords
- Peripheral Intravenous Catheterization, ShotBlocker, Pain, Anxiety, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Collaborators
- Kayseri City Hospital
- Study start
- 18 Apr 2026 (actual)
- Primary completion
- 29 May 2026 (actual)
- Study completion
- 29 May 2026 (actual)
- First posted
- 28 Apr 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.
This randomized controlled trial aims to evaluate the effect of the ShotBlocker device on pain, anxiety, and patient satisfaction during peripheral intravenous catheterization (PIVC). Peripheral intravenous catheterization is a commonly performed procedure in clinical settings and is often associated with pain and anxiety, which may negatively affect patient experience.
The ShotBlocker is a simple, non-pharmacological device designed to reduce pain by applying pressure and sensory stimulation at the injection site. Participants will be randomly assigned to either the intervention group, where the ShotBlocker will be used during the procedure, or the control group, where routine care will be provided.Pain will be assessed using the Visual Analog Scale (VAS). Anxiety and patient satisfaction will be evaluated using a visual analog-based scale supported , combining features of the Visual Analog Scale and the Wong-Baker Faces Scale, with scores ranging from 0 to 10. The findings of this study are expected to contribute to evidence-based nursing practices by providing an effective, low-cost, and non-invasive method for reducing procedural discomfort and improving patient experience during PIVC.
Detailed description
Peripheral intravenous catheterization (PIVC) is one of the most frequently performed invasive procedures in clinical practice. Despite its routine nature, it is commonly associated with pain and anxiety, which may negatively influence patient comfort, satisfaction, and overall experience of care. Therefore, effective and practical strategies to reduce procedure-related discomfort are essential in nursing practice.
The ShotBlocker is a simple, non-pharmacological device designed to reduce pain by applying mechanical pressure and providing sensory distraction at the injection site. It is inexpensive, easy to use, and does not require additional training or pharmacological intervention, making it suitable for routine clinical use.
This study is designed as a randomized controlled trial to evaluate the effectiveness of the ShotBlocker device during PIVC. Participants will be randomly assigned to either the intervention group, in which the ShotBlocker will be applied during the catheterization procedure, or the control group, in which routine care will be provided without any additional intervention.
Pain intensity will be assessed using the Visual Analog Scale (VAS). Anxiety and patient satisfaction will be evaluated using a visual analog-based scale supported by combining features of the Visual Analog Scale and the Wong-Baker Faces Scale, with scores ranging from 0 to 10.
All procedures will be performed by trained healthcare professionals following standard clinical protocols. Data will be collected immediately after the procedure. The primary outcome of the study is pain intensity, while secondary outcomes include anxiety and patient satisfaction.
The results of this study are expected to provide evidence for the effectiveness of a simple, non-invasive, and cost-effective method to reduce procedure-related discomfort and improve patient-centered care in clinical settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the intervention group (ShotBlocker) or the control group (routine care) in a parallel design.
| Arm | Type | Receives |
|---|---|---|
| ShotBlocker Group | Experimental | Device: ShotBlockerParticipants will receive peripheral intravenous catheterization using the ShotBlocker device during the procedure. |
| Control Group | No intervention | –Participants will receive routine peripheral intravenous catheterization without the use of the ShotBlocker device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals aged 18 years and older Patients requiring peripheral intravenous catheterization Patients who are conscious and able to communicate Patients who agree to participate in the study and provide informed consent
Key exclusion criteria (1 listed)
- Patients with cognitive impairment or inability to communicate Patients with a history of chronic pain or current use of analgesics Patients with dermatological conditions or wounds at the catheterization site Patients who previously experienced peripheral intravenous catheterization within the last 24 hours Patients who refuse to participate in 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 |
|---|---|---|
| ShotBlockerA non-pharmacological device applied to the skin to reduce pain through mechanical pressure and sensory stimulation during peripheral intravenous catheterization. | Device | ShotBlocker Group |
Primary outcome
Pain Intensity During Peripheral Intravenous Catheterization
Time frame: Immediately after the procedure
Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain).
2 secondary outcomes
Anxiety Level
Time frame: Before and immediately after the procedure
Patient Satisfaction
Time frame: Immediately after the procedure
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 30 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Acute Pain
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
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.
Emine Korkmaz, PhD principal investigator
Kirsehir Ahi Evran Universitesi
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 Acute Pain and Anxiety, run by Kirsehir Ahi Evran Universitesi 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 1 inclusion and 1 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 30 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?
Pain Intensity During Peripheral Intravenous Catheterization (time frame: Immediately after the procedure). 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 30 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.