- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06947525
Effects of Shotblocker and Manual Pressure on Pain and Satisfaction
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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,
- 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)
Exclusion Criteria:
- The individual wants to leave the study,
- Feels unwell during the PIC placement (such as dizziness, palpitations),
- Uses sedatives or alcohol,
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Manual pressure
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.
|
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.
|
|
Experimental: Shotblocker
In the Shotblocker group, the shotblocker will be placed 2 cm above the vein entry point and will remain throughout the procedure.
|
In the Shotblocker group, the shotblocker will be placed 2 cm above the vein entry point and will remain throughout the procedure.
|
|
No Intervention: Control
The control group will undergo standard peripheral catheter placement without any intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
The peripheral venous catheter will be filled within 1 minute after insertion.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Satisfaction Scale
Time Frame: The peripheral venous catheter will be filled within 1 minute after insertion.
|
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.
|
The peripheral venous catheter will be filled within 1 minute after insertion.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NecErUn
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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