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

NCT ID: NCT07190547

Last Updated: 2025-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-25
• Study Completion Date: 2025-12-20

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.

Conditions

Children; Preschool; Pain Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

intervention group (ShotBloker )

ShotBloker

Group Type: EXPERIMENTAL

ShotBloker

Intervention Type: OTHER

ShotBlocker is a flat, horseshoe-shaped device used to reduce pain during subcutaneous or intramuscular (IM) injections. It features short, blunt, non-sharp projections approximately 2 mm in height and is designed to be placed against the skin, with a central opening that exposes the injection site. The device is applied to the skin just prior to injection, with its textured surface making contact with the skin. Although the projections do not penetrate the skin, they are believed to create a sensory stimulus associated with pain modulation based on the gate control theory.

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

intervention group (helper skin tap)

Group Type: EXPERIMENTAL

Helfer skin tap

Intervention Type: OTHER

Helfer Skin Tap Technique:

After determining the injection site, gently tap the skin several times with the fingertips of the dominant (most commonly used) hand for approximately 5 seconds to relax the muscle. After the skin is wiped with antiseptic solution and stretched, the cap of the syringe in the dominant (most commonly used) hand is opened. A large V is made with the thumb and index finger of the non-dominant hand. The skin is tapped three times quickly using the whole hand to stimulate the major muscle fibers. The nurse/midwife counts to 3, and the needle is inserted into the muscle at a 90-degree angle simultaneously. To remove the needle from the skin, the skin is tapped three times quickly (again in a V shape) with the whole non-dominant hand, and the needle is withdrawn simultaneously with the final tap (tapping).

Interventions

ShotBloker

ShotBlocker is a flat, horseshoe-shaped device used to reduce pain during subcutaneous or intramuscular (IM) injections. It features short, blunt, non-sharp projections approximately 2 mm in height and is designed to be placed against the skin, with a central opening that exposes the injection site. The device is applied to the skin just prior to injection, with its textured surface making contact with the skin. Although the projections do not penetrate the skin, they are believed to create a sensory stimulus associated with pain modulation based on the gate control theory.

Intervention Type: OTHER

Helfer skin tap

Helfer Skin Tap Technique:

After determining the injection site, gently tap the skin several times with the fingertips of the dominant (most commonly used) hand for approximately 5 seconds to relax the muscle. After the skin is wiped with antiseptic solution and stretched, the cap of the syringe in the dominant (most commonly used) hand is opened. A large V is made with the thumb and index finger of the non-dominant hand. The skin is tapped three times quickly using the whole hand to stimulate the major muscle fibers. The nurse/midwife counts to 3, and the needle is inserted into the muscle at a 90-degree angle simultaneously. To remove the needle from the skin, the skin is tapped three times quickly (again in a V shape) with the whole non-dominant hand, and the needle is withdrawn simultaneously with the final tap (tapping).

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sakarya University

OTHER

Sponsor Role: lead

Responsible Party

öznur tiryaki

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sakarya University

Sakarya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Nalan Yalçınkaya Sezer

Identifier Type: -

Identifier Source: org_study_id