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Clinical Trials in Turkey / NCT07655310
Recruiting Observational

Socio-Cultural Level, Health Literacy, and Parental CT Demand in Paediatric Minor Head Trauma

NCT07655310 · tracked via the Priya Life Science Turkey tracker
Sponsor
Bursa Yuksek Ihtisas Training and Research Hospital
Phase
Observational
Started
2024-04-10
Last updated
2026-06-22

Condition(s) studied

Craniocerebral TraumaBrain Injuries, TraumaticHead Injuries, Closed

Study summary

Minor head trauma is one of the most frequent reasons for paediatric emergency department visits worldwide. The PECARN (Paediatric Emergency Care Applied Research Network) clinical decision rule stratifies children with minor head trauma into low-, intermediate-, and high-risk categories for clinically important traumatic brain injury (ciTBI) and provides evidence-based guidance on computed tomography (CT) ordering. Despite its high diagnostic accuracy, real-world CT utilisation frequently diverges from PECARN recommendations. Non-clinical family-level factors - including socio-cultural characteristics and health literacy - may drive part of this divergence, particularly through their influence on whether families explicitly request CT imaging.

This prospective observational cohort study will enrol 200 children with minor head trauma presenting to the emergency department of SBU Bursa Yuksek Ihtisas EAH, Bursa, Turkey. The primary aim is to determine whether family socio-cultural level (composite index incorporating education, occupation, income, and housing; scored 0-10) and health literacy (Newest Vital Sign-Turkish, NVS-TR) independently predict parental demand for CT imaging. Secondary aims include determining whether parental CT demand and family socio-cultural characteristics predict CT ordering by the treating physician, describing PECARN algorithm adherence patterns in this setting, and examining parental health-seeking behaviour at 7-day telephone follow-up.

Eligibility

Sex
ALL
Min age
—
Max age
17 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Parental Request for CT Head Imaging — At emergency department presentation (index visit, Day 0)
    Explicit verbal request by the accompanying parent or guardian for CT head to be performed, documented by the treating physician at the time of PECARN risk assessment (recorded as Yes / No / Not stated). Operationalised as any affirmative parental request for CT regardless of the physician's independent clinical assessment. Responses of Not stated will be handled as missing data and imputed under the MICE procedure.

Trial sites (1)

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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07655310 on ClinicalTrials.gov ↗ ← All trials in Turkey