An interventional study of ShotBlocker in Acute Pain and Anxiety, sponsored by Kirsehir Ahi Evran Universitesi. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by Kirsehir Ahi Evran Universitesi · Not applicable, Interventional, and Treatment
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.
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.
876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's planned enrollment of 100 is above the median of 90 across 732 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →Kirsehir Ahi Evran Universitesi is the lead sponsor of 133 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Participants will receive peripheral intravenous catheterization using the ShotBlocker device during the procedure.
Device: ShotBlocker
Participants will receive routine peripheral intravenous catheterization without the use of the ShotBlocker device.
A non-pharmacological device applied to the skin to reduce pain through mechanical pressure and sensory stimulation during peripheral intravenous catheterization.
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).
Time frame: Immediately after the procedure
Anxiety Level
Anxiety will be assessed using a visual analog scale with scores ranging from 0 to 10, both before and immediately after the procedure.
Time frame: Before and immediately after the procedure
Patient Satisfaction
Patient satisfaction will be assessed immediately after the procedure using a visual analog-based scale supported by , with scores ranging from 0 to 10.
Time frame: Immediately after the procedure
Plan to share: No
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This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Kirsehir Ahi Evran Universitesi