Effects of Shotblocker and Manual Pressure on Pain and Satisfaction

April 20, 2025 updated by: Serpil SU, Necmettin Erbakan University

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

Not yet recruiting

Conditions

Study Type

Interventional

Enrollment (Estimated)

81

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 28, 2025

Primary Completion (Estimated)

April 28, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

April 20, 2025

First Submitted That Met QC Criteria

April 20, 2025

First Posted (Actual)

April 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 20, 2025

Last Verified

April 1, 2025

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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