Status:

COMPLETED

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

Lead Sponsor:

Sakarya University

Conditions:

Children

Preschool

Eligibility:

All Genders

4-6 years

Phase:

NA

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. Acc...

Eligibility Criteria

Inclusion

  • 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

    Key Trial Info

    Start Date :

    September 25 2025

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 20 2025

    Estimated Enrollment :

    120 Patients enrolled

    Trial Details

    Trial ID

    NCT07190547

    Start Date

    September 25 2025

    End Date

    December 20 2025

    Last Update

    December 30 2025

    Active Locations (1)

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    1

    Sakarya University

    Sakarya, Turkey (Türkiye)

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