NCT07655310 Socio-Cultural Level, Health Literacy, and Parental CT Demand in Paediatric Minor Head Trauma
| NCT ID | NCT07655310 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bursa Yuksek Ihtisas Training and Research Hospital |
| Condition | Craniocerebral Trauma |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-04-10 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-04-10 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Zulfi Engindeniz, MD
PRINCIPAL INVESTIGATOR
SBU Bursa Yuksek Ihtisas Egitim ve Arastirma Hastanesi
Frequently Asked Questions
Who can join the NCT07655310 clinical trial?
This trial is open to participants of all sexes, up to 17 Years, studying Craniocerebral Trauma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07655310 currently recruiting?
Yes, NCT07655310 is actively recruiting participants. Contact the research team at zengindeniz@gmail.com for enrollment information.
Where is the NCT07655310 trial being conducted?
This trial is being conducted at Bursa, Turkey (Türkiye).
Who is sponsoring the NCT07655310 clinical trial?
NCT07655310 is sponsored by Bursa Yuksek Ihtisas Training and Research Hospital. The principal investigator is Zulfi Engindeniz, MD at SBU Bursa Yuksek Ihtisas Egitim ve Arastirma Hastanesi. The trial plans to enroll 200 participants.