Craniocerebral TraumaNCT07655310
Socio-Cultural Level, Health Literacy, and Parental CT Demand in Paediatric Minor Head Trauma
An observational study of Craniocerebral Trauma and Brain Injuries, Traumatic, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Craniocerebral Trauma, Brain Injuries, Traumatic, Head Injuries, Closed
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2024to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
SBU Bursa Yuksek Ihtisas Egitim ve Arastirma Hastanesi
Bursa
Zulfu Engindeniz, MD, +905334169101, zengindeniz@gmail.com
Zulfu Engindeniz, MD
About this study
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
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.
Read the detailed description
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.
- 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
- Medical subject headings
- Craniocerebral Trauma, Brain Injuries, Traumatic, Head Injuries, Closed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At emergency department presentation (index visit, Day 0)
Secondary outcomes (5)
CT Head Ordered
Binary outcome: CT head ordered (Yes) or not ordered (No) by the treating emergency physician following PECARN risk stratification and clinical assessment.
Measured: At emergency department presentation (index visit, Day 0)
PECARN Algorithm Adherence Category
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.
Measured: At emergency department presentation (index visit, Day 0)
Emergency Department Re-presentation Within 7 Days
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.
Measured: 7 days after index emergency department discharge
Clinically Important Traumatic Brain Injury (ciTBI)
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.
Measured: 7 days after emergency department presentation
Physician-Assessed Parental Anxiety at Presentation
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.
Measured: At emergency department presentation (index visit, Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start10 Apr 2024
- Primary completionJul 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Craniocerebral TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zulfı engındenız, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Zulfi Engindeniz, MD, Principal investigator, SBU Bursa Yuksek Ihtisas Egitim ve Arastirma HastanesiMehmet Demir, MD, Study director, SBU Bursa Yuksek Ihtisas Egitim ve Arastirma Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655310
- Sponsor's protocol ID
- 2024-TBEK-2024-04-16
- Other IDs
- 2024-TBEK 2024/04-16
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: we have not decided where to share IPD
Publications
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.
PubMed 19758692Ratcliffe 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.
PubMed 28522968Sahiner IT, Akpinar Z, Demir O, et al. Validity and reliability of the Turkish version of the Newest Vital Sign. J Community Health. 2020.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07655310
- Acronym / sponsor ID
- 2024-TBEK-2024-04-16
- Keywords
- PECARN, paediatric head trauma, minor head trauma, computed tomography, health literacy, socio-cultural level, clinical decision rule, parental CT demand
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Parental Request for CT Head Imaging
Time frame: 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.
5 secondary outcomes
CT Head Ordered
Time frame: At emergency department presentation (index visit, Day 0)
PECARN Algorithm Adherence Category
Time frame: At emergency department presentation (index visit, Day 0)
Emergency Department Re-presentation Within 7 Days
Time frame: 7 days after index emergency department discharge
Clinically Important Traumatic Brain Injury (ciTBI)
Time frame: 7 days after emergency department presentation
Physician-Assessed Parental Anxiety at Presentation
Time frame: At emergency department presentation (index visit, Day 0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Background: PubMed 19758692Kuppermann 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.
- Background: PubMed 28522968Ratcliffe 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.
- BackgroundSahiner IT, Akpinar Z, Demir O, et al. Validity and reliability of the Turkish version of the Newest Vital Sign. J Community Health. 2020.
- Individual participant dataSharing planned: Undecided. we have not decided where to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zulfi Engindeniz, MD principal investigator
SBU Bursa Yuksek Ihtisas Egitim ve Arastirma Hastanesi
Mehmet Demir, MD study director
SBU Bursa Yuksek Ihtisas Egitim ve Arastirma Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Craniocerebral Trauma and Brain Injuries, Traumatic, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zulfi Engindeniz, MD (+905334169101, zengindeniz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Request for CT Head Imaging (time frame: At emergency department presentation (index visit, Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07655310, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.