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

NCT07655310 | Recruiting

• 2 other identifiers: 2024-TBEK-2024-04-162024-TBEK 2024/04-16
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Craniocerebral Trauma; Brain Injuries, Traumatic; Head Injuries, Closed

Keywords

PECARN; paediatric head trauma; minor head trauma; computed tomography; health literacy; socio-cultural level; clinical decision rule; parental CT demand; emergency medicine; NVS-TR

Outcome Measures

Primary Outcomes (1)

• Parental Request for CT Head Imaging

  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)

Secondary Outcomes (5)

• CT Head Ordered

  At emergency department presentation (index visit, Day 0)

• PECARN Algorithm Adherence Category

  At emergency department presentation (index visit, Day 0)

• Emergency Department Re-presentation Within 7 Days

  7 days after index emergency department discharge

• Clinically Important Traumatic Brain Injury (ciTBI)

  7 days after emergency department presentation

• Physician-Assessed Parental Anxiety at Presentation

  At emergency department presentation (index visit, Day 0)

Study Arms (1)

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.

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

SBU Bursa Yuksek Ihtisas Egitim ve Arastirma Hastanesi

Bursa, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Kuppermann N, Holmes JF, Dayan PS, Hoyle JD Jr, Atabaki SM, Holubkov R, Nadel FM, Monroe D, Stanley RM, Borgialli DA, Badawy MK, Schunk JE, Quayle KS, Mahajan P, Lichenstein R, Lillis KA, Tunik MG, Jacobs ES, Callahan JM, Gorelick MH, Glass TF, Lee LK, Bachman MC, Cooper A, Powell EC, Gerardi MJ, Melville KA, Muizelaar JP, Wisner DH, Zuspan SJ, Dean JM, Wootton-Gorges SL; Pediatric Emergency Care Applied Research Network (PECARN). Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study. Lancet. 2009 Oct 3;374(9696):1160-70. doi: 10.1016/S0140-6736(09)61558-0. Epub 2009 Sep 14.

  PMID: 19758692 BACKGROUND

• Ratcliffe N, Newport R. The Effect of Visual, Spatial and Temporal Manipulations on Embodiment and Action. Front Hum Neurosci. 2017 May 4;11:227. doi: 10.3389/fnhum.2017.00227. eCollection 2017.

  PMID: 28522968 BACKGROUND

• Sahiner IT, Akpinar Z, Demir O, et al. Validity and reliability of the Turkish version of the Newest Vital Sign. J Community Health. 2020.

  BACKGROUND

MeSH Terms

Conditions

Craniocerebral Trauma; Brain Injuries, Traumatic; Head Injuries, Closed

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Wounds, Nonpenetrating

Study Officials

• Zulfi Engindeniz, MD

  SBU Bursa Yuksek Ihtisas Egitim ve Arastirma Hastanesi

  PRINCIPAL INVESTIGATOR

• Mehmet Demir, MD

  SBU Bursa Yuksek Ihtisas Egitim ve Arastirma Hastanesi

  STUDY DIRECTOR

Central Study Contacts

Zulfi Engindeniz, MD

CONTACT

+905334169101; zengindeniz@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Physician, Emergency Medicine

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start: April 10, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-01

Locations

TU (1)