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

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.

NCT Number	NCT07669961
Lead Sponsor	Mersin University
Conditions	Procedural Pain, Pain-related Fear
Enrollment	68 participants
Start Date	2026-06-21
Primary Completion	2026-09-15 (estimated)
Study Completion	2026-11-20 (estimated)
Updated on ClinicalTrials.gov	2026-06-29