Trauma (Including Fractures)NCT07811830
Stress in Trauma Patients in Triage Categories 3-5
An observational study of Trauma (Including Fractures), run by Gabriela Katharina Pomper at 1 site in Croatia.
Trial summary
The aim of this study is to better understand what causes patients the most concern immediately after an injury. We would like to find out how stressed patients are and whether the main causes of stress are pain, fear regarding the severity of the injury, the possibility of surgery, uncertainty about treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma (Including Fractures)
- What is being tested?
- Questionnaire and Physical Exam
- How many people
- 300 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Sep 2026to 31 Aug 2028
- How long will I take part?
- 2 Days
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients aged 18 years or older presenting to the Emergency Department with an acute traumatic injury and classified as triage category 3, 4, or 5. Eligible participants must be clinically stable after the initial medical assessment, able to understand the study information and questionnaires, and capable of providing written informed consent. Patients who require hospitalization will additionally complete a follow-up questionnaire approximately 24 hours after admission.
Who may be able to join
- Age 18 years or older.
- Presentation to the Emergency Department because of an acute traumatic injury.
- Triage category 3, 4, or 5.
- Clinical stability after the initial assessment.
- Ability to understand the study information and the questionnaire.
- Ability to provide written informed consent
Who cannot join
- Triage category 1 or 2 (an acutely life-threatening condition or an immediate need for emergency medical or surgical intervention; hemodynamic or respiratory instability).
- Severe impairment of consciousness, disorientation, or inability to cooperate.
- Inability to provide informed consent; cognitive impairment or a language barrier preventing comprehension of the questions.
- Severe alcohol or drug intoxication preventing valid completion of the questionnaire.
- A situation in which completion of the questionnaire is inappropriate for medical, ethical, or organizational reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site
OŽB Požega
Požega, 34000
Director of the General County Hospital Požega., MD, PHD, 003834254506, ivan.vukoja@pozeska-bolnica.hr
Head of Emergency Department, MD, 003834254804, matko.šperanda@pozeska-bolnica.hr
About this study
Official title: Assessment of Acute Stress and Main Sources of Concern Among Trauma Patients in Triage Categories 3-5 in the Emergency Department: A Prospective Observational Study
The aim of this study is to better understand what causes patients the most concern immediately after an injury. We would like to find out how stressed patients are and whether the main causes of stress are pain, fear regarding the severity of the injury, the possibility of surgery, uncertainty about treatment, concerns about family, children, work, finances, or something else.
Read the detailed description
Traumatic injuries are a common reason for seeking care in an Emergency Department. Beyond the physical effects of an injury, patients may also experience considerable emotional stress. They may worry about pain, how serious the injury is, whether surgery will be necessary, how long recovery will take, possible long-term consequences, and how the injury may affect their family, children, work, or financial situation.
In patients who are medically stable, especially those with less immediately life-threatening injuries, this emotional burden is not always assessed in a structured way. However, these patients are often able to complete a short questionnaire about their concerns and stress. Understanding their experiences may help healthcare professionals improve communication, provide clearer information, and offer better support during emergency care.
The aim of this study is to measure acute stress in trauma patients and identify the concerns that matter most to them shortly after injury. For patients who are admitted to the hospital, the study will also examine how stress levels and the main sources of concern change during the first 24 hours after admission.
- Conditions
- Trauma (Including Fractures)
- Being tested
- Questionnaire and Physical Exam
- Keywords
- trauma, acute stress, emergency department, hospitalization, emergency care
- Medical subject headings
- Wounds and Injuries, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and Physical ExamOther
Participants complete a brief questionnaire assessing acute stress, pain, treatment-related concerns, family and work-related concerns, and perceived information and communication. The T0 questionnaire is administered after initial emergency assessment. Hospitalized participants complete an additional T1 questionnaire approximately 24 hours after admission.
| Study group | Role | What they receive |
|---|---|---|
| Triage Category 3 | Clinically stable adult trauma patients classified as triage category 3 after initial emergency assessment. Receives: Other: Questionnaire and Physical Exam | |
| Triage Category 4 | Clinically stable adult trauma patients classified as triage category 4 after initial emergency assessment. Receives: Other: Questionnaire and Physical Exam | |
| Triage Category 5 | Clinically stable adult trauma patients classified as triage category 5 after initial emergency assessment. Receives: Other: Questionnaire and Physical Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Acute Stress Level
Overall level of acute stress measured using a numerical rating scale from 0 to 10, where 0 indicates no stress and 10 indicates the highest possible level of stress.
Measured: At day 1, after initial assessment
Secondary outcomes (7)
Individual Sources of Stress at T0
Severity of specific stressors, including pain, concerns about injury severity, possible surgery, anesthesia, treatment uncertainty, permanent consequences, family, children, work, and financial concerns, each rated on a 0-10 numerical scale.
Measured: At day 1, after initial Emergency Department assessment.
Difference in Overall Stress Between Triage Categories 3, 4, and 5
Description: Comparison of overall acute stress scores among trauma patients classified as triage category 3, 4, or 5.
Measured: At day 1.
Association Between Pain Intensity and Overall Stress
Description: Association between self-reported pain intensity and overall acute stress level, both measured on numerical rating scales from 0 to 10.
Measured: At day 1.
Overall Stress Score According to Injury Type and Anatomical Location
Overall stress will be assessed using a patient-reported 11-point Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 indicates no stress and 10 indicates the highest imaginable level of stress.
Overall stress scores will be compared according to the type of traumatic injury and the anatomical location of the injury. Injury type and anatomical location will be determined from the clinical assessment and medical documentation at presentation to the Emergency Department and categorized for analysis.
Higher scores indicate a higher level of overall stress.
Measured: At day 1.
Change in Overall Stress Score Assessed by the Study-Specific Acute Trauma Stress Questionnaire From T0 to T1
Change in overall stress level between the initial Emergency Department assessment and approximately 24 hours after hospital admission among hospitalized participants.
Measured: From day 1 to approximately 24 hours after admission.
Change in Dominant Sources of Stress Assessed by the Study-Specific Acute Trauma Stress Questionnaire From T0 to T1
Change in the most important patient-reported sources of stress between the initial assessment and approximately 24 hours after admission.
Measured: From day 1 to approximately 24 hours after admission.
Correlation Between Overall Stress Score and Patient-Reported Information and Understanding Score
Correlation between the patient's overall stress level and the patient's perceived level of information and understanding regarding the current treatment plan.
Overall stress will be assessed using a patient-reported Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 indicates no stress and 10 indicates the highest imaginable level of stress.
The perceived level of information and understanding of the treatment plan will be assessed using a patient-reported Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 indicates feeling not informed/not understanding the treatment plan at all and 10 indicates feeling fully informed and having
Measured: At day 1 and, for hospitalized participants, approximately 24 hours after admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma (Including Fractures)Studies 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
- 300 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Gabriela Katharina Pomper
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gabriela Katharina Pomper, Opća županijska bolnica Požega
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811830
- Sponsor's protocol ID
- PozegaBolnica
- Other IDs
- Ur.broj: 02-7/3-3/2-2-2026
- Status last verified
- Sep 2026
- First submitted
- 29 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: ndividual participant data (IPD) will not be shared publicly because the study involves sensitive patient-reported psychological and clinical information collected in the acute trauma setting. Although the dataset will be pseudonymized, the relatively small study population and detailed clinical variables may still carry a potential risk of participant re-identification. Therefore, IPD will be restricted to the study investigators and will not be made publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Acute Stress and Main Sources of Concern Among Trauma Patients in Triage Categories 3-5 in the Emergency Department: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07811830
- Acronym / sponsor ID
- PozegaBolnica
- Conditions
- Trauma (Including Fractures)
- Keywords
- trauma, acute stress, emergency department, hospitalization, emergency care
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Gabriela Katharina PomperUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 10 Sep 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.
The aim of this study is to better understand what causes patients the most concern immediately after an injury. We would like to find out how stressed patients are and whether the main causes of stress are pain, fear regarding the severity of the injury, the possibility of surgery, uncertainty about treatment, concerns about family, children, work, finances, or something else.
Detailed description
Traumatic injuries are a common reason for seeking care in an Emergency Department. Beyond the physical effects of an injury, patients may also experience considerable emotional stress. They may worry about pain, how serious the injury is, whether surgery will be necessary, how long recovery will take, possible long-term consequences, and how the injury may affect their family, children, work, or financial situation.
In patients who are medically stable, especially those with less immediately life-threatening injuries, this emotional burden is not always assessed in a structured way. However, these patients are often able to complete a short questionnaire about their concerns and stress. Understanding their experiences may help healthcare professionals improve communication, provide clearer information, and offer better support during emergency care.
The aim of this study is to measure acute stress in trauma patients and identify the concerns that matter most to them shortly after injury. For patients who are admitted to the hospital, the study will also examine how stress levels and the main sources of concern change during the first 24 hours after admission.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Triage Category 3 | – | Other: Questionnaire and Physical ExamClinically stable adult trauma patients classified as triage category 3 after initial emergency assessment. |
| Triage Category 4 | – | Other: Questionnaire and Physical ExamClinically stable adult trauma patients classified as triage category 4 after initial emergency assessment. |
| Triage Category 5 | – | Other: Questionnaire and Physical ExamClinically stable adult trauma patients classified as triage category 5 after initial emergency assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients aged 18 years or older presenting to the Emergency Department with an acute traumatic injury and classified as triage category 3, 4, or 5. Eligible participants must be clinically stable after the initial medical assessment, able to understand the study information and questionnaires, and capable of providing written informed consent. Patients who require hospitalization will additionally complete a follow-up questionnaire approximately 24 hours after admission.
Key inclusion criteria (6 listed)
- Age 18 years or older.
- Presentation to the Emergency Department because of an acute traumatic injury.
- Triage category 3, 4, or 5.
- Clinical stability after the initial assessment.
- Ability to understand the study information and the questionnaire.
Key exclusion criteria (5 listed)
- Triage category 1 or 2 (an acutely life-threatening condition or an immediate need for emergency medical or surgical intervention; hemodynamic or respiratory instability).
- Severe impairment of consciousness, disorientation, or inability to cooperate.
- Inability to provide informed consent; cognitive impairment or a language barrier preventing comprehension of the questions.
- Severe alcohol or drug intoxication preventing valid completion of the questionnaire.
- A situation in which completion of the questionnaire is inappropriate for medical, ethical, or organizational reasons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire and Physical ExamParticipants complete a brief questionnaire assessing acute stress, pain, treatment-related concerns, family and work-related concerns, and perceived information and communication. The T0 questionnaire is administered after initial emergency assessment. Hospitalized participants complete an additional T1 questionnaire approximately 24 hours after admission. | Other | Triage Category 3, Triage Category 4, Triage Category 5 |
Primary outcome
Overall Acute Stress Level
Time frame: At day 1, after initial assessment
Overall level of acute stress measured using a numerical rating scale from 0 to 10, where 0 indicates no stress and 10 indicates the highest possible level of stress.
7 secondary outcomes
Individual Sources of Stress at T0
Time frame: At day 1, after initial Emergency Department assessment.
Difference in Overall Stress Between Triage Categories 3, 4, and 5
Time frame: At day 1.
Association Between Pain Intensity and Overall Stress
Time frame: At day 1.
Overall Stress Score According to Injury Type and Anatomical Location
Time frame: At day 1.
Change in Overall Stress Score Assessed by the Study-Specific Acute Trauma Stress Questionnaire From T0 to T1
Time frame: From day 1 to approximately 24 hours after admission.
Change in Dominant Sources of Stress Assessed by the Study-Specific Acute Trauma Stress Questionnaire From T0 to T1
Time frame: From day 1 to approximately 24 hours after admission.
Correlation Between Overall Stress Score and Patient-Reported Information and Understanding Score
Time frame: At day 1 and, for hospitalized participants, approximately 24 hours after admission.
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 10 Sep 2026.
- Individual participant dataSharing planned: No. ndividual participant data (IPD) will not be shared publicly because the study involves sensitive patient-reported psychological and clinical information collected in the acute trauma setting. Although the dataset will be pseudonymized, the relatively small study population and detailed clinical variables may still carry a potential risk of participant re-identification. Therefore, IPD will be restricted to the study investigators and will not be made publicly available.
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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.
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 Trauma (Including Fractures), run by Gabriela Katharina Pomper at 1 site in Croatia.
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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 10 Sep 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 Croatia. 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 Gabriela K Pomper, MD, PHD (003834254532, gabrielakatharina@pozeska-bolnica.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Acute Stress Level (time frame: At day 1, after initial assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2026.