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

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated September 21, 2026 (before its estimated October 7, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Sep 15, 2026 to Oct 7, 2026
    • Start date: Jun 21, 2026 to Jun 27, 2026
    • Secondary endpoints: details revised at 2 of 2 entries
    • Eligibility criteria expanded, about 4 words
  2. Eligibility criteria revised
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description shortened, about 166 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07669961
Lead Sponsor Mersin University
Conditions
(from sponsor)		 Procedural Pain, Pain-related Fear
Related terms Procedural Pain
Enrollment 68 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov