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Recruiting
NCT07669961
Distraction Cards Versus Emotion-Regulation Toy Squeezing During Intramuscular Vaccination in Preschool Children
Conditions: Procedural Pain, Pain-related Fear
Sex: All
Ages: 4 Years – 7 Years
Healthy volunteers: No
Phase: NA
Enrollment: 68
Sponsor: Mersin University
Location: Mersin University Hospital Mersin Province
Summary
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.
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
Source: ClinicalTrials.gov (NCT07669961). StuddyBuddy aggregates publicly available trial information.