- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07811830
Stress in Trauma Patients in Triage Categories 3-5
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Gabriela K Pomper, MD, PHD
- Phone Number: 003834254532
- Email: gabrielakatharina@pozeska-bolnica.hr
Study Locations
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Požega, Croatia, 34000
- OŽB Požega
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Contact:
- Director of the General County Hospital Požega., MD, PHD
- Phone Number: 003834254506
- Email: ivan.vukoja@pozeska-bolnica.hr
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Contact:
- Head of Emergency Department, MD
- Phone Number: 003834254804
- Email: matko.šperanda@pozeska-bolnica.hr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Triage Category 3
Clinically stable adult trauma patients classified as triage category 3 after initial emergency assessment.
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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.
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Triage Category 4
Clinically stable adult trauma patients classified as triage category 4 after initial emergency assessment.
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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.
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Triage Category 5
Clinically stable adult trauma patients classified as triage category 5 after initial emergency assessment.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Overall Acute Stress Level
Time Frame: At day 1, after initial assessment
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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.
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At day 1, after initial assessment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Individual Sources of Stress at T0
Time Frame: At day 1, after initial Emergency Department assessment.
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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.
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At day 1, after initial Emergency Department assessment.
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Difference in Overall Stress Between Triage Categories 3, 4, and 5
Time Frame: At day 1.
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Description: Comparison of overall acute stress scores among trauma patients classified as triage category 3, 4, or 5.
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At day 1.
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Association Between Pain Intensity and Overall Stress
Time Frame: At day 1.
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Description: Association between self-reported pain intensity and overall acute stress level, both measured on numerical rating scales from 0 to 10.
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At day 1.
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Overall Stress Score According to Injury Type and Anatomical Location
Time Frame: At day 1.
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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. |
At day 1.
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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.
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Change in overall stress level between the initial Emergency Department assessment and approximately 24 hours after hospital admission among hospitalized participants.
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From day 1 to approximately 24 hours after admission.
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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.
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Change in the most important patient-reported sources of stress between the initial assessment and approximately 24 hours after admission.
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From day 1 to approximately 24 hours after admission.
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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.
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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 |
At day 1 and, for hospitalized participants, approximately 24 hours after admission.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Pathological Conditions, Signs and Symptoms
- Emergencies
- Wounds and Injuries
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Therapeutics
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Behavior Control
- Immobilization
- Surveys and Questionnaires
- Restraint, Physical
Other Study ID Numbers
- PozegaBolnica
- Ur.broj: 02-7/3-3/2-2-2026 (Other Identifier: Ethics Committee of the General County Hospital Požega)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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