Helfer Technique and ShotBlocker in Reducing Pain, Fear, and Anxiety in Children

Not Applicable

Not yet recruiting

• Conditions: Pain Management; Children; Preschool

• Registration Number: NCT07190547
• Lead Sponsor: Sakarya University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-18
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-16
• Last Update Submitted: 2025-09-16
• Study First Posted: 2025-09-24
• Last Update Posted: 2025-09-24
• Study Start: 2025-09-25
• Primary Completion: 2025-10-15
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Children aged between 4 and 6 years,
• An intramuscular (IM) medication order was prescribed by a physician,
• The IM injection was administered in the pediatric emergency department,
• No history of chronic pain-causing illness,
• No diagnosis of neurodevelopmental disorders,
• Had not received any analgesic medications in the past 6 hours,
• No history of syncope (fainting) during previous injections,

No diagnosis of mental retardation,

• No scar tissue or muscle atrophy at the intended injection site,
• Body mass index (BMI) percentile between the 10th and 90th percentiles for age and gender,
• Both child and parent provided informed consent to participate in the study.

Exclusion Criteria;

• Participants were excluded from the study if:
• The child was younger than 4 or older than 6 years,
• There was scar tissue or muscle atrophy at the injection site,
• The child or parent had communication difficulties,
• The child's BMI was below the 10th percentile (cachectic) or above the 90th percentile (obese),
• Either the child or parent declined to participate in the research.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Measurement Tool	12 weeks	he Wong-Baker FACES Pain Rating Scale was used to assess self-reported pain levels. This scale consists of six facial expressions ranging from "no hurt" (0) to "hurts worst" (10), allowing children to select the face that best represents their level of pain.
Assessment Time	12 weeks	Pain scores were recorded immediately after the injection.Developed by Wong and Baker, it features six hand-drawn facial expressions on a horizontal plane. Scored from 0 to 10, the leftmost face features a smiling face, representing "no pain." Pain increases from left to right. The rightmost face features a face with tears, representing "unbearable pain."
Measurement Tool (Fear Level)	12 weeks	The Children's Fear Scale was used to assess the child's level of fear. This visual scale consists of five facial expressions depicting increasing levels of fear (scores range from 0 to 4). from neutral expression (0=no anxiety) to frightened face (4=severe anxiety)