Stress in Trauma Patients in Triage Categories 3-5

NCT07811830 | Not Yet Recruiting DMC

• 2 other identifiers: PozegaBolnicaUr.broj: 02-7/3-3/2-2-2026
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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, concerns about family, children, work, finances, or something else.

Conditions

Trauma (Including Fractures)

Keywords

trauma; acute stress; emergency department; hospitalization; emergency care

Outcome Measures

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.

  At day 1, after initial assessment

Secondary Outcomes (7)

• Individual Sources of Stress at T0

  At day 1, after initial Emergency Department assessment.

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

  At day 1.

• Association Between Pain Intensity and Overall Stress

  At day 1.

• Overall Stress Score According to Injury Type and Anatomical Location

  At day 1.

• Change in Overall Stress Score Assessed by the Study-Specific Acute Trauma Stress Questionnaire From T0 to T1

  From day 1 to approximately 24 hours after admission.

Study Arms (3)

Triage Category 3

Clinically stable adult trauma patients classified as triage category 3 after initial emergency assessment.

Other: Questionnaire and Physical Exam

Triage Category 4

Clinically stable adult trauma patients classified as triage category 4 after initial emergency assessment.

Other: Questionnaire and Physical Exam

Triage Category 5

Clinically stable adult trauma patients classified as triage category 5 after initial emergency assessment.

Other: Questionnaire and Physical Exam

Interventions

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.

Triage Category 3; Triage Category 4; Triage Category 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gabriela Katharina Pomper: lead

Study Sites (1)

OŽB Požega

Požega, 34000, Croatia

Location

MeSH Terms

Conditions

Wounds and Injuries; Emergencies

Interventions

Surveys and Questionnaires; Restraint, Physical

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization

Central Study Contacts

Gabriela K Pomper, MD, PHD

CONTACT

003834254532; gabrielakatharina@pozeska-bolnica.hr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist for Plastic, Reconstructive and Aesthetic Surgery

Study Record Dates

• First Submitted: August 29, 2026
• First Posted: September 10, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)