Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Stress in Trauma Patients in Triage Categories 3-5

3. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

300

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Triage Category 3
Clinically stable adult trauma patients classified as triage category 3 after initial emergency assessment.
Sonstiges: 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.
Sonstiges: 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.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall Acute Stress Level
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Individual Sources of Stress at T0
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Gabriela Katharina Pomper

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

31. August 2028

Studienabschluss (Geschätzt)

31. August 2028

Studienanmeldedaten

Zuerst eingereicht

29. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. September 2026

Zuerst gepostet (Tatsächlich)

10. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren