Health Trials

Stress in Trauma Patients in Triage Categories 3-5

ConditionTrauma (Including Fractures)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGabriela Katharina Pomper

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Questionnaire and Physical Exam

    Other intervention

    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.

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: Triage Category 31 intervention
Group B: Triage Category 41 intervention
Group C: Triage Category 51 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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.
2

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.
3

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.
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gabriela Katharina Pomper

Lead sponsor

Opća županijska bolnica Požega

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: