Clinical trial Recruiting at 1 site Interventional Ages 4 to 7

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 typeInterventional
Ages4 Years to 7 Years
SexAll
Enrollment68 (estimated)
SponsorMersin University
Academic / other
Locations1 site (Mersin, Province)
StatusRecruiting
StartedJune 27, 2026
Main results expectedNovember 11, 2026
Study endsNovember 20, 2026
Registry record updatedOctober 26, 2026
Trial IDNCT07669961 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.