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The Effect of Using Distraction Card and Squeezing Emotion-Regulation Toy on Pain and Pain-Related Fear During Intramuscular Vaccination in Children Aged 4-7 Years: A Single-Center, Parallel-Group, Randomized Experimental Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 7
Healthy Volunteers: f
View:

• Child aged 4-7 years

• Child with need or plan for intramuscular vaccination

Locations
Other Locations
Turkey
Mersin University Hospital
RECRUITING
Mersin
Time Frame
Start Date: 2026-06-27
Estimated Completion Date: 2026-11-20
Participants
Target number of participants: 68
Treatments
Active_comparator: Distraction-Card Group
Arm type: Experimental. Behavioral intervention: active distraction-card use. 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.
Experimental: Emotion-Regulation Toy-Squeezing Group
Arm type: Experimental. Behavioral intervention: active emotion-regulation toy squeezing. 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.
Related Therapeutic Areas
Sponsors
Leads: Mersin University

This content was sourced from clinicaltrials.gov

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