Distraction Cards vs Emotion-Regulation Toy Squeezing During Vaccination for Preschoolers
Official title: 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
Run by Mersin University · NCT07669961 · Data updated 2026-11-12
This trial tests whether distraction cards or emotion-regulation toy squeezing better reduce pain and fear during an intramuscular tetanus shot for 4- to 7-year-olds.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 4 Years to 7 Years |
| Sex | All |
| Enrollment | 68 (estimated) |
| Sponsor | Mersin University Academic / other |
| Locations | 1 site (Mersin, Province) |
| Status | Recruiting |
| Started | June 27, 2026 |
| Main results expected | November 11, 2026 |
| Study ends | November 20, 2026 |
| Registry record updated | October 26, 2026 |
| Trial ID | NCT07669961 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 4–7 years who require an intramuscular vaccination.
✕Probably not a fit
Children outside the 4–7 age range or those with conditions or recent medication use that meet exclusion criteria may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In a single-center, randomized design, 68 children aged 4–7 years scheduled for an intramuscular tetanus vaccination are assigned to either distraction cards or emotion-regulation toy squeezing during the procedure. Pain is measured with the Wong-Baker FACES scale and fear with the Children's Fear Scale before, during, and after the injection. The environment is standardized to minimize external influences, and a pediatric-experienced nurse administers the vaccination in a quiet, child-friendly room. Parental presence is allowed, and the same clinician ideally treats children across groups. Results will indicate which non-pharmacologic approach more effectively reduces procedural pain and fear in young children.
Why it matters
Potential benefit: If successful, the approach that most reduces pain and fear could be adopted in pediatric vaccination practices to ease the experience for children.
How similar studies have gone: Prior studies have demonstrated that distraction and emotion regulation strategies can reduce procedural distress in pediatric settings, though direct comparisons in vaccination contexts are limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Mersin University Hospital
Mersin, Province, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: GUZIDE UGUCU, RN, MScN, PhD — Mersin University
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.