The Effect of ShotBlocker on Pain, Anxiety, and Satisfaction During Peripheral Intravenous Catheterization (SB-PIVC)

April 23, 2026 updated by: Emine Korkmaz, Kirsehir Ahi Evran Universitesi

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ShotBlocker Group
Participants will receive peripheral intravenous catheterization using the ShotBlocker device during the procedure.
Device: ShotBlocker
A non-pharmacological device applied to the skin to reduce pain through mechanical pressure and sensory stimulation during peripheral intravenous catheterization.
No Intervention: Control Group
Participants will receive routine peripheral intravenous catheterization without the use of the ShotBlocker device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Immediately after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety Level
Time Frame: Before and immediately after the procedure
Anxiety will be assessed using a visual analog scale with scores ranging from 0 to 10, both before and immediately after the procedure.
Before and immediately after the procedure
Patient Satisfaction
Time Frame: Immediately after the procedure
Patient satisfaction will be assessed immediately after the procedure using a visual analog-based scale supported by , with scores ranging from 0 to 10.
Immediately after the procedure

Collaborators and Investigators

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

Sponsor

Kirsehir Ahi Evran Universitesi

Collaborators

Kayseri City Hospital

Investigators

  • Principal Investigator: Emine Korkmaz, PhD, Kirsehir Ahi Evran Universitesi

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 18, 2026

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

April 17, 2026

First Submitted That Met QC Criteria

April 23, 2026

First Posted (Actual)

April 28, 2026

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SB-PIVC-01

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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