PainNCT06947525
Effects of Shotblocker and Manual Pressure on Pain and Satisfaction
A study testing Manual pressure and Shotblocker in people with Pain and Satisfaction, run by Necmettin Erbakan University.
Trial summary
This study aims to determine the effects of shotblocker and manual pressure applied during peripheral venous catheter placement on pain and satisfaction. 81 patients hospitalized in the Urology clinic will be included in the study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Satisfaction
- What is being tested?
- Manual pressure and Shotblocker
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- 28 Apr 2025to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission to the urology clinic,
- No verbal, perceptual and visual communication problems,
- Between the ages of 18 and 65,
- Literate,
- Volunteer to participate in the study,
- Not using medication that will create a chronic analgesic effect,
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- Not having chronic or acute pain,
- No intervention has been performed on the vein where the PIC is placed in the last month,
- No scar tissue or infection in the areas where the PIC will be placed,
- Not having a disease that will cause problems in feeling pain (such as neuropathy)
Who cannot join
- The individual wants to leave the study,
- Feels unwell during the PIC placement (such as dizziness, palpitations),
- Uses sedatives or alcohol,
About this study
Official title: Effects of Shotblocker and Manual Pressure on Pain and Satisfaction During Peripheral Venous Catheter Placement: A Randomized Controlled Trial
This study aims to determine the effects of shotblocker and manual pressure applied during peripheral venous catheter placement on pain and satisfaction. 81 patients hospitalized in the Urology clinic will be included in the study. Patients will be assigned to three groups as shotblocker (n=27), manual pressure (n=27) and control group (n=27) by block randomization method.
Research Hypotheses
- H1-1: The mean pain scores of the intervention group to which shotblocker was applied during peripheral intravenous catheterization are different from the control group.
- H1-2: The mean pain scores of the intervention group to which manual pressure was applied during peripheral intravenous catheterization are different from the control group.
- H1-3: The mean satisfaction scores of the intervention group to which shotblocker was applied during peripheral intravenous catheterization are different from the control group.
- H1-4: The mean satisfaction scores of the intervention group to which manual pressure was applied during peripheral intravenous catheterization are different from the control group.
- Conditions
- Pain, Satisfaction
- Being tested
- Manual pressure, Shotblocker
- Medical subject headings
- Pain, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual pressureOther
Before the procedure in the manual pressure group, the vein entry area will be pressed with the right hand thumb for 10 seconds. The pressure will be applied until the nail bed turns white.
ShotblockerOther
In the Shotblocker group, the shotblocker will be placed 2 cm above the vein entry point and will remain throughout the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Manual pressure | Experimental | Before placing a peripheral intravenous catheter in the manual pressure group, the vein entry area will be pressed with the right thumb for 10 seconds. The pressure will be applied until the nail bed turns white. Receives: Other: Manual pressure |
| Shotblocker | Experimental | In the Shotblocker group, the shotblocker will be placed 2 cm above the vein entry point and will remain throughout the procedure. Receives: Other: Shotblocker |
| Control | No intervention | The control group will undergo standard peripheral catheter placement without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
The minimum score on the scale is 0 and the maximum score is 10. A score of 0 indicates no pain, while a score of 10 indicates unbearable pain.
Measured: The peripheral venous catheter will be filled within 1 minute after insertion.
Secondary outcomes (1)
Patient Satisfaction Scale
It is a horizontal scale that can be scored between 0 and 10. It is a measurement tool that starts with "I am not satisfied at all - 0" - "I am very satisfied - 10" and ends with.The minimum score on the scale is 0 and the maximum is 10. A score of 0 indicates that the procedure is not satisfactory at all, while a score of 10 indicates that the procedure is very satisfactory.
Measured: The peripheral venous catheter will be filled within 1 minute after insertion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start28 Apr 2025 (estimated)
- Primary completion28 Apr 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
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.
- More trials run by Necmettin Erbakan 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serpil SU, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947525
- Sponsor's protocol ID
- NecErUn
- Status last verified
- Apr 2025
- First submitted
- 20 Apr 2025
- Last updated
- 27 Apr 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 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Shotblocker and Manual Pressure on Pain and Satisfaction During Peripheral Venous Catheter Placement: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06947525
- Acronym / sponsor ID
- NecErUn
- Conditions
- Pain, Satisfaction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 28 Apr 2025 (estimated)
- Primary completion
- 28 Apr 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 27 Apr 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.
This study aims to determine the effects of shotblocker and manual pressure applied during peripheral venous catheter placement on pain and satisfaction. 81 patients hospitalized in the Urology clinic will be included in the study. Patients will be assigned to three groups as shotblocker (n=27), manual pressure (n=27) and control group (n=27) by block randomization method.
Research Hypotheses
- H1-1: The mean pain scores of the intervention group to which shotblocker was applied during peripheral intravenous catheterization are different from the control group.
- H1-2: The mean pain scores of the intervention group to which manual pressure was applied during peripheral intravenous catheterization are different from the control group.
- H1-3: The mean satisfaction scores of the intervention group to which shotblocker was applied during peripheral intravenous catheterization are different from the control group.
- H1-4: The mean satisfaction scores of the intervention group to which manual pressure was applied during peripheral intravenous catheterization are different from the control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Manual pressure | Experimental | Other: Manual pressureBefore placing a peripheral intravenous catheter in the manual pressure group, the vein entry area will be pressed with the right thumb for 10 seconds. The pressure will be applied until the nail bed turns white. |
| Shotblocker | Experimental | Other: ShotblockerIn the Shotblocker group, the shotblocker will be placed 2 cm above the vein entry point and will remain throughout the procedure. |
| Control | No intervention | –The control group will undergo standard peripheral catheter placement without any intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Admission to the urology clinic,
- No verbal, perceptual and visual communication problems,
- Between the ages of 18 and 65,
- Literate,
- Volunteer to participate in the study,
Key exclusion criteria (3 listed)
- The individual wants to leave the study,
- Feels unwell during the PIC placement (such as dizziness, palpitations),
- Uses sedatives or alcohol,
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 |
|---|---|---|
| Manual pressureBefore the procedure in the manual pressure group, the vein entry area will be pressed with the right hand thumb for 10 seconds. The pressure will be applied until the nail bed turns white. | Other | Manual pressure |
| ShotblockerIn the Shotblocker group, the shotblocker will be placed 2 cm above the vein entry point and will remain throughout the procedure. | Other | Shotblocker |
Primary outcome
Visual Analog Scale (VAS)
Time frame: The peripheral venous catheter will be filled within 1 minute after insertion.
The minimum score on the scale is 0 and the maximum score is 10. A score of 0 indicates no pain, while a score of 10 indicates unbearable pain.
1 secondary outcome
Patient Satisfaction Scale
Time frame: The peripheral venous catheter will be filled within 1 minute after insertion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Manual pressure and Shotblocker in people with Pain and Satisfaction, run by Necmettin Erbakan University.
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 10 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: opening soon, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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: The peripheral venous catheter will be filled within 1 minute after insertion.). 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 27 Apr 2025.