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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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.

Eligibility

Primary outcome measure(s)

• Procedural pain score during intramuscular vaccination — during the procedure at needle insertion/vaccine administration
  Procedural pain score during intramuscular tetanus vaccination, assessed using the Wong-Baker FACES Pain Rating Scale. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst/unbearable pain. Higher scores indicate greater pain.
• Pain-related fear score during intramuscular vaccination — during the procedure at needle insertion/vaccine administration
  Pain-related fear score during intramuscular tetanus vaccination, assessed using the Children's Fear Scale. The scale ranges from 0 to 4, from a neutral/no-fear face to a very fearful face. Higher scores indicate greater fear.

Trial sites (1)

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