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

NCT07669961 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2026-06-29

No results posted yet for this study

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.

Conditions

  • Procedural Pain
  • Pain-related Fear

Interventions

BEHAVIORAL

Distraction-Card Group

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.

BEHAVIORAL

Emotion-Regulation Toy-Squeezing Group

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.

Sponsors & Collaborators

  • Mersin University

    lead OTHER

Principal Investigators

  • GUZIDE UGUCU, RN, MScN, PhD · Mersin University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-21
Primary Completion
2026-09-15
Completion
2026-11-20

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07669961 on ClinicalTrials.gov