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The Effect of the Helfer Technique and ShotBlocker Application on Pain, Fear, and Anxiety in Children Receiving Intramuscular Injections: A Randomized Controlled Trial
Various methods can be used to reduce pain experienced by children in emergency departments. However, the most critical requirement is that the method used must provide fast and effective results. Accordingly, it is essential that interventions in emergency settings are performed in a way that minimizes pain and anxiety in children and helps prevent the long-term consequences of pain (1, 2). Recently, the Helfer Skin Tap Technique (HSTT)-used to reduce stress and pain-and the ShotBlocker®, a device with small projections designed to reduce pain when applied to the skin, have gained attention (3,4,5). ShotBlocker is a non-invasive, U-shaped plastic device with small bumps, used to decrease injection-related pain, especially in children who are highly sensitive to pain (6). In addition, a device known as Buzzy®, shaped like a bee and combining external cold application with vibration, is also commonly used. It has been proven effective in reducing pain during invasive procedures such as intramuscular (IM) injections and IV line insertions in pediatric patients (7,8). The analgesic effect of the Buzzy® device is attributed to two main mechanisms: reduced signal transmission in peripheral nerves and the gate control theory. The application of cold and vibrational stimuli to the skin activates tactile receptors, leading to the release of endogenous opioids and a subsequent decrease in pain perception (8). Reducing pain and fear during IM injections-one of the most common painful procedures in pediatric emergency departments-is a key midwifery/nursing intervention. The authority of midwives and nurses to use non-pharmacological methods during IM injections is clearly defined in their respective professional regulations. Given the nature of pediatric emergency units, midwives and nurses contribute significantly to increasing both child and parent comfort by using practical, fast-acting, and low-cost methods that can be easily implemented during painful procedures. Demonstrating the positive effects of non-pharmacological methods on reducing pain and fear in children of different age groups during IM injections is crucial, both for enriching the literature and for encouraging the widespread use of evidence-based, cost-effective practices in clinical settings. Making such approaches a routine part of care delivery in pediatric units is of great importance. The aim of the study was to investigate the effects of ShotBlocker and HSTT on the pain and fear experienced by children aged 4-6 years during IM injection in pediatric emergency departments.
Age
4 - 6 years
Sex
ALL
Healthy Volunteers
Yes
Sakarya University
Sakarya, Turkey (Türkiye)
Start Date
September 25, 2025
Primary Completion Date
October 15, 2025
Completion Date
December 20, 2025
Last Updated
December 30, 2025
120
ACTUAL participants
ShotBloker
OTHER
Helfer skin tap
OTHER
Lead Sponsor
Sakarya University
NCT07360600
NCT07468006
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07327463