The Effect of ShotBlocker on Pain, Anxiety, and Satisfaction During Peripheral Intravenous Catheterization

NCT07553624 | Not Yet Recruiting

• 1 other identifier: SB-PIVC-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Acute Pain; Anxiety

Keywords

Peripheral Intravenous Catheterization; ShotBlocker; Pain; Anxiety; Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• 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).

  Immediately after the procedure

Secondary Outcomes (2)

• Anxiety Level

  Before and immediately after the procedure

• Patient Satisfaction

  Immediately after the procedure

Study Arms (2)

ShotBlocker Group

EXPERIMENTAL

Participants will receive peripheral intravenous catheterization using the ShotBlocker device during the procedure.

Device: ShotBlocker

Control Group

NO INTERVENTION

Participants will receive routine peripheral intravenous catheterization without the use of the ShotBlocker device.

Interventions

ShotBlocker DEVICE

A non-pharmacological device applied to the skin to reduce pain through mechanical pressure and sensory stimulation during peripheral intravenous catheterization.

ShotBlocker Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead
• Kayseri City Hospital: collaborator

Study Sites (1)

Kayseri City Hospital

Kayseri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Pain; Anxiety Disorders; Pain; Patient Satisfaction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Emine Korkmaz, PhD

  Kirsehir Ahi Evran Universitesi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emine Korkmaz, PhD, RN

CONTACT

+905054912144; eminebes@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Blinding is not feasible due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomly assigned to either the intervention group (ShotBlocker) or the control group (routine care) in a parallel design.

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 28, 2026
• Study Start: April 18, 2026
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)