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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Mersin University • ClinicalTrials.gov ID: NCT07669961

Registry updated: 2026-09-21
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Description

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.

Interventions

  • Distraction-Card Group (Behavioral)
    Age-appropriate visual distraction cards suitable for children aged 3-6 years will be used. Cards should be cleanable or single-use according to infection-control practice and should include developmentally appropriate visual content that can maintain the child's attention during the procedure. Two minutes before the intramuscular tetanus vaccination begins, the child will start using age-appropriate distraction cards. The child will be actively engaged with the cards through visual attention and simple prompts until the injection procedure is completed.
  • Emotion-Regulation Toy-Squeezing Group (Behavioral)
    A safe, age-appropriate, cleanable, medium-firm squeezable emotion-regulation toy appropriate for children aged 3-6 years will be used. The toy should be resistant to tearing and damage and suitable for infection-control procedures between participants if reusable. Two minutes before the intramuscular tetanus vaccination begins, the child will start squeezing an age-appropriate emotion-regulation toy. The toy-squeezing intervention will continue until the injection procedure is completed.

Eligibility criteria

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

Conditions

Procedural Pain Pain-related Fear

Locations

  • Mersin University Hospital — Mersin, Province, Turkey (Türkiye)
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record