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Distraction Cards Versus Emotion-Regulation Toy Squeezing During Intramuscular Vaccination in Preschool Children

RecruitingNAAges 4 Years - 7 YearsAllMersin University
NCT07669961 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This single-center, parallel-group, randomized experimental study will compare the effects of two active non-pharmacological interventions - distraction-card use and emotion-regulation toy squeezing - on procedural pain and pain-related fear during intramuscular tetanus vaccination in children aged 4-7 years. Eligible children will be randomized to either the distraction-card group or the emotion-regulation toy-squeezing group. Pain will be assessed using the Wong-Baker FACES Pain Rating Scale, and pain-related fear will be assessed using the Children's Fear Scale before, during, and after the intramuscular injection procedure. Hypotheses * H1a: There is a difference between the groups in mean Wong-Baker FACES scores during the procedure. * H1b: There is a difference between the groups in mean Children's Fear Scale scores during the procedure.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Child aged 4-7 years * Child with need or plan for intramuscular vaccination Exclusion Criteria: * Child with a neurodegenerative disease, mental retardation, vision and hearing problems, chronic, life-threatening (sepsis, shock, respiratory / cardiac arrest) or genetic disease * Child with use of opioids, narcotics, analgesics or sedatives in the last 24 hours before the procedure
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What it tests

  • Distraction-Card Group
  • Emotion-Regulation Toy-Squeezing Group
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Where

1 site
Mersin University Hospital
Mersin, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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