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NCT Number: NCT07811830

Stress in Trauma Patients in Triage Categories 3-5

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.

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Key information

Conditions

Trauma (Including Fractures) Disease Attributes Emergencies Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionnaire and Physical Exam

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Individual Sources of Stress at T0

    Time frame: At day 1, after initial Emergency Department assessment.

    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.

  2. Difference in Overall Stress Between Triage Categories 3, 4, and 5

    Time frame: At day 1.

    Description: Comparison of overall acute stress scores among trauma patients classified as triage category 3, 4, or 5.

  3. Association Between Pain Intensity and Overall Stress

    Time frame: At day 1.

    Description: Association between self-reported pain intensity and overall acute stress level, both measured on numerical rating scales from 0 to 10.

  4. Overall Stress Score According to Injury Type and Anatomical Location

    Time frame: At day 1.

    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.

  5. 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 overall stress level between the initial Emergency Department assessment and approximately 24 hours after hospital admission among hospitalized participants.

  6. 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.

    Change in the most important patient-reported sources of stress between the initial assessment and approximately 24 hours after admission.

  7. 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.

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriela K Pomper, MD, PHD

CONTACT

[email protected]

003834254532

Sponsors and collaborators

Lead sponsor

Gabriela Katharina Pomper

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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