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Stress in Trauma Patients in Triage Categories 3-5

3 settembre 2026 aggiornato da: Gabriela Katharina Pomper

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

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

300

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

Inclusion Criteria:

  1. Age 18 years or older.
  2. Presentation to the Emergency Department because of an acute traumatic injury.
  3. Triage category 3, 4, or 5.
  4. Clinical stability after the initial assessment.
  5. Ability to understand the study information and the questionnaire.
  6. Ability to provide written informed consent

Exclusion Criteria:

  1. Triage category 1 or 2 (an acutely life-threatening condition or an immediate need for emergency medical or surgical intervention; hemodynamic or respiratory instability).
  2. Severe impairment of consciousness, disorientation, or inability to cooperate.
  3. Inability to provide informed consent; cognitive impairment or a language barrier preventing comprehension of the questions.
  4. Severe alcohol or drug intoxication preventing valid completion of the questionnaire.
  5. A situation in which completion of the questionnaire is inappropriate for medical, ethical, or organizational reasons.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Triage Category 3
Clinically stable adult trauma patients classified as triage category 3 after initial emergency assessment.
Altro: 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.
Triage Category 4
Clinically stable adult trauma patients classified as triage category 4 after initial emergency assessment.
Altro: 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.
Triage Category 5
Clinically stable adult trauma patients classified as triage category 5 after initial emergency assessment.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Acute Stress Level
Lasso di tempo: 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.
At day 1, after initial assessment

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Individual Sources of Stress at T0
Lasso di tempo: 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.
At day 1, after initial Emergency Department assessment.
Difference in Overall Stress Between Triage Categories 3, 4, and 5
Lasso di tempo: At day 1.
Description: Comparison of overall acute stress scores among trauma patients classified as triage category 3, 4, or 5.
At day 1.
Association Between Pain Intensity and Overall Stress
Lasso di tempo: 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.
At day 1.
Overall Stress Score According to Injury Type and Anatomical Location
Lasso di tempo: 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.
At day 1.
Change in Overall Stress Score Assessed by the Study-Specific Acute Trauma Stress Questionnaire From T0 to T1
Lasso di tempo: 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.
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
Lasso di tempo: 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.
From day 1 to approximately 24 hours after admission.
Correlation Between Overall Stress Score and Patient-Reported Information and Understanding Score
Lasso di tempo: 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
At day 1 and, for hospitalized participants, approximately 24 hours after admission.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Gabriela Katharina Pomper

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

31 agosto 2028

Completamento dello studio (Stimato)

31 agosto 2028

Date di iscrizione allo studio

Primo inviato

29 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 settembre 2026

Primo Inserito (Effettivo)

10 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PozegaBolnica
  • Ur.broj: 02-7/3-3/2-2-2026 (Altro identificatore: Ethics Committee of the General County Hospital Požega)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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