Clinical trial Recruiting at 1 site Observational Ages Any age to 17

Socio-Cultural Factors, Health Literacy, and Parental CT Demand in Pediatric Minor Head Trauma

Official title: The Relationship Between Family Socio-Cultural Level, Health Literacy, and Parental Demand for Computed Tomography in PECARN-Stratified Children Presenting With Minor Head Trauma: A Single-Centre Prospective Observational Cohort Study

Run by Bursa Yuksek Ihtisas Training and Research Hospital · NCT07655310 · Data updated 2026-11-12

This study tests how family background and health literacy relate to decisions about CT imaging for kids with minor head injuries.

More Brain Injuries, Traumatic trials

Quick facts

Study typeObservational
AgesAny age to 17 Years
SexAll
Enrollment200 (estimated)
SponsorBursa Yuksek Ihtisas Training and Research Hospital
Government
Locations1 site (Bursa)
StatusRecruiting
StartedApril 10, 2024
Main results expectedJuly 2026
Study endsAugust 2027
Registry record updatedJune 22, 2026
Trial IDNCT07655310 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Children under 18 with minor head trauma presenting to the Bursa Yuksek Ihtisas Emergency Department and whose parent or guardian can provide informed consent.

Probably not a fit

Children with more severe head injury, non-consenting guardians, or injuries outside the 24-hour window may not benefit from insights about imaging decisions.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-center observational study will enroll 200 children under 18 with minor head trauma at a Turkish emergency department. Clinicians will classify risk using the PECARN rule, while family socio-cultural level and health literacy are measured with validated tools, and parental requests for CT imaging are documented. By comparing PECARN risk with real-world imaging decisions and parental factors, the study aims to understand non-clinical drivers of CT use. Data collection is designed to minimize information bias by masking the socio-cultural assessment from the treating team during decision-making. The findings could explain why CT usage diverges from PECARN guidance in routine practice.

Why it matters

Potential benefit: If successful, results could inform targeted strategies to align imaging decisions with clinical risk and improve communication about CT use.

How similar studies have gone: Previous studies have shown variation between PECARN recommendations and actual CT use; this study adds a focus on family-level drivers in a Turkish setting.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Age less than 18 years at time of emergency department presentation
2. Presenting complaint of head trauma sustained within the preceding 24 hours
3. Classified as minor head trauma at triage, defined as a Glasgow Coma Scale (GCS) score of 14 or 15 at initial assessment
4. Accompanied by a parent or legal guardian with capacity to provide written informed consent

Exclusion Criteria:

1. GCS score 13 or less at presentation (moderate or severe head injury)
2. Transfer from another medical facility
3. Head trauma sustained more than 24 hours before emergency department presentation
4. Known coagulopathy, anticoagulant therapy, or bleeding disorder
5. Ventriculoperitoneal shunt in situ
6. Previous intracranial neurosurgery
7. Pre-existing neurological disorder affecting GCS interpretation (e.g., cerebral palsy, developmental delay)
8. Clinical suspicion of abusive head trauma (non-accidental injury) identified by the treating physician
9. Concurrent multi-system trauma
10. No accompanying parent or guardian available for consent and socio-cultural assessment

Where it's running

  • SBU Bursa Yuksek Ihtisas Egitim ve Arastirma Hastanesi
    Bursa, Turkey (Türkiye)
    Recruiting

Study contacts

  • Principal investigator: Zulfi Engindeniz, MD — SBU Bursa Yuksek Ihtisas Egitim ve Arastirma Hastanesi
  • Study coordinator: Zulfi Engindeniz, MD
  • Email: zengindeniz@gmail.com
  • Phone: +905334169101

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.