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Socio-Cultural Level, Health Literacy, and Parental CT Demand in Paediatric Minor Head Trauma: A Prospective Cohort Study

12 giugno 2026 aggiornato da: Zulfı engındenız, Bursa Yuksek Ihtisas Training and Research Hospital

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

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Descrizione dettagliata

BACKGROUND: The PECARN rule classifies children with minor head trauma into three risk categories. Despite international validation, studies consistently document wide variation in CT utilisation. Turkey-specific data from Bursa and other centres confirm that fewer than half of cases are managed in strict accordance with PECARN guidance. Non-clinical drivers of this variation - including family socio-cultural level and health literacy - have not been systematically examined. Two mechanistic pathways are proposed: (1) families with lower health literacy or socio-cultural level may be more or less likely to explicitly request CT imaging; (2) physicians may respond to perceived family demand or anxiety in ways that are unrelated to clinical risk.

DESIGN: Single-centre prospective observational cohort study. Consecutive paediatric patients with minor head trauma (GCS 14-15, age under 18 years) are enrolled at SBU Bursa Yuksek Ihtisas EAH. The treating physician completes PECARN risk stratification and the CT decision field before the research coordinator's socio-cultural assessment is visible on the CRF, preventing information bias. Socio-cultural level is measured using a validated composite index (education 0-3, occupation 0-3, income 0-2, housing 0-2; total 0-10; Low 0-3, Mid 4-6, High 7-10). Health literacy is measured using the Newest Vital Sign-Turkish (NVS-TR; Cronbach alpha 0.720; cutoff >= 4 = adequate health literacy). Parental CT demand is documented using the CRF item "Did the family request CT?" (Yes/No/Not stated). PECARN adherence is classified as Adherent, Deviant, or Partial. Seven-day telephone follow-up captures ED re-presentation and new neurological symptoms.

SAMPLE SIZE: Powered on CT ordering (conservative proxy for CT demand) using a two-proportion z-test: p1 = 0.70 (low health literacy), p2 = 0.45 (adequate health literacy); alpha = 0.05 two-tailed; power = 80%. Required n = 138; adjusted for 15% loss to follow-up = 163; rounded to n = 200 to accommodate logistic regression (5 predictors, events per variable >= 15) and intermediate-risk subgroup analysis.

ANALYSIS: Primary - chi-squared test comparing parental CT request rates between low and high health literacy groups, stratified by PECARN risk category. Multivariable - two logistic regression models: Model A (parental CT demand as outcome) and Model B (CT ordering as outcome, including parental CT demand as predictor). Mediation - counterfactual causal mediation framework (Imai et al., 2010) testing whether parental CT demand mediates the effect of socio-cultural level on CT ordering, and whether NVS-TR mediates the effect of socio-cultural level on parental CT demand. Missing data - multiple imputation by chained equations (MICE; m = 20).

ETHICS: Approved by the Institutional Ethics Committee of SBU Bursa Yuksek Ihtisas EAH (Protocol 2024-TBEK 2024/04-16; 05 April 2024). Written informed consent obtained from parent/guardian; verbal assent from children aged 8 and older. No financial compensation. No external funding.

Tipo di studio

Osservativo

Iscrizione (Stimato)

200

Contatti e Sedi

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Contatto studio

Luoghi di studio

  • Turchia (Türkiye)
      • Bursa, Turchia (Türkiye)
        • Reclutamento
        • SBU Bursa Yuksek Ihtisas Egitim ve Arastirma Hastanesi
        • Contatto:
        • Investigatore principale:
          • Zulfu Engindeniz, MD
        • Sub-investigatore:
          • Mehmet Demir, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

No

Metodo di campionamento

Campione di probabilità

Popolazione di studio

Consecutive paediatric patients (age under 18 years) presenting to the emergency department of SBU Bursa Yuksek Ihtisas Egitim ve Arastirma Hastanesi, a 1,200-bed tertiary referral and training hospital in Bursa, Turkey, with minor head trauma (GCS 14-15) within 24 hours of injury, accompanied by a parent or legal guardian. The ED serves a sociodemographically diverse urban and peri-urban catchment area and records approximately 170,000 adult and paediatric visits annually.

Descrizione

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

Piano di studio

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Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Children with minor head trauma
Consecutive patients aged under 18 years presenting to the emergency department with minor head trauma (GCS 14-15) within 24 hours of injury, accompanied by a parent or legal guardian able to provide written informed consent.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Parental Request for CT Head Imaging
Lasso di tempo: 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.
At emergency department presentation (index visit, Day 0)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
CT Head Ordered
Lasso di tempo: At emergency department presentation (index visit, Day 0)
Binary outcome: CT head ordered (Yes) or not ordered (No) by the treating emergency physician following PECARN risk stratification and clinical assessment.
At emergency department presentation (index visit, Day 0)
PECARN Algorithm Adherence Category
Lasso di tempo: At emergency department presentation (index visit, Day 0)
Three-category prospective classification assigned by the treating physician. Adherent: management matched PECARN guidance for the assigned risk category (CT in high-risk; CT or observation in intermediate-risk; no CT in low-risk). Deviant: management discordant with PECARN (CT ordered in a low-risk patient [unnecessary CT], or CT withheld in a high-risk patient [missed CT]). Partial: applicable exclusively to intermediate-risk patients in whom structured observation was bypassed and CT ordered immediately without a preceding observation phase.
At emergency department presentation (index visit, Day 0)
Emergency Department Re-presentation Within 7 Days
Lasso di tempo: 7 days after index emergency department discharge
Re-attendance at any emergency department within 7 days of the index visit, as determined by structured telephone follow-up conducted at 7 days post-discharge by the research coordinator.
7 days after index emergency department discharge
Clinically Important Traumatic Brain Injury (ciTBI)
Lasso di tempo: 7 days after emergency department presentation
ciTBI defined as any of the following attributable to traumatic brain injury: death; neurosurgical intervention; intubation for more than 24 hours; or hospital admission for at least two nights. Identified either on index CT or reported at 7-day telephone follow-up.
7 days after emergency department presentation
Physician-Assessed Parental Anxiety at Presentation
Lasso di tempo: At emergency department presentation (index visit, Day 0)
Parental anxiety level as assessed by the treating physician using a 10-point visual analogue scale (0 = not anxious at all; 10 = maximally anxious), completed at the time of clinical assessment.
At emergency department presentation (index visit, Day 0)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Investigatori

  • Investigatore principale: Zulfi Engindeniz, MD, SBU Bursa Yuksek Ihtisas Egitim ve Arastirma Hastanesi
  • Direttore dello studio: Mehmet Demir, MD, SBU Bursa Yuksek Ihtisas Egitim ve Arastirma Hastanesi

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

10 aprile 2024

Completamento primario (Stimato)

1 luglio 2026

Completamento dello studio (Stimato)

1 agosto 2027

Date di iscrizione allo studio

Primo inviato

12 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

12 giugno 2026

Primo Inserito (Effettivo)

17 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 giugno 2026

Ultimo verificato

1 gennaio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2024-TBEK-2024-04-16
  • 2024-TBEK 2024/04-16 (Altro identificatore: Institutional Ethics Committee, SBU Bursa Yuksek Ihtisas EAH)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

we have not decided where to share IPD

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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