An observational study in Trauma (Including Fractures), sponsored by Gabriela Katharina Pomper. Not yet recruiting at 1 site in Croatia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Gabriela Katharina Pomper · Observational
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.
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.
2,217 studies on the registry are indexed under Wounds and Injuries; 441 are open to participants now.
This study's planned enrollment of 300 is above the median of 169 across 690 observational studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →This is the only study on the registry with Gabriela Katharina Pomper as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically stable adult trauma patients classified as triage category 3 after initial emergency assessment.
Other: Questionnaire and Physical Exam
Clinically stable adult trauma patients classified as triage category 4 after initial emergency assessment.
Other: Questionnaire and Physical Exam
Clinically stable adult trauma patients classified as triage category 5 after initial emergency assessment.
Other: Questionnaire and Physical Exam
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.
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.
Time frame: At day 1, after initial assessment
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
Change in the most important patient-reported sources of stress between the initial assessment and approximately 24 hours after admission.
Time frame: 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
Time frame: At day 1 and, for hospitalized participants, approximately 24 hours after admission.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Start is estimated for Sep 2026; primary completion for Aug 2028, 23 months later.
Of 265 non-industry observational studies under Wounds and Injuries, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 60. This study's planned 23 months is below that.
Counting every sponsor, half of 312 studies reached it within 28 months; a quarter within 12 and three quarters within 60.
Wounds and Injuries covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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