- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07811830
Stress in Trauma Patients in Triage Categories 3-5
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
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Gabriela K Pomper, MD, PHD
- Numer telefonu: 003834254532
- E-mail: gabrielakatharina@pozeska-bolnica.hr
Lokalizacje studiów
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Požega, Chorwacja, 34000
- OŽB Požega
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Kontakt:
- Director of the General County Hospital Požega., MD, PHD
- Numer telefonu: 003834254506
- E-mail: ivan.vukoja@pozeska-bolnica.hr
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Kontakt:
- Head of Emergency Department, MD
- Numer telefonu: 003834254804
- E-mail: matko.šperanda@pozeska-bolnica.hr
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
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Triage Category 3
Clinically stable adult trauma patients classified as triage category 3 after initial emergency assessment.
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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.
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Triage Category 4
Clinically stable adult trauma patients classified as triage category 4 after initial emergency assessment.
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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.
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Triage Category 5
Clinically stable adult trauma patients classified as triage category 5 after initial emergency assessment.
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Overall Acute Stress Level
Ramy czasowe: At day 1, after initial assessment
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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.
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At day 1, after initial assessment
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Individual Sources of Stress at T0
Ramy czasowe: At day 1, after initial Emergency Department assessment.
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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.
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At day 1, after initial Emergency Department assessment.
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Difference in Overall Stress Between Triage Categories 3, 4, and 5
Ramy czasowe: At day 1.
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Description: Comparison of overall acute stress scores among trauma patients classified as triage category 3, 4, or 5.
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At day 1.
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Association Between Pain Intensity and Overall Stress
Ramy czasowe: At day 1.
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Description: Association between self-reported pain intensity and overall acute stress level, both measured on numerical rating scales from 0 to 10.
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At day 1.
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Overall Stress Score According to Injury Type and Anatomical Location
Ramy czasowe: At day 1.
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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.
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Change in Overall Stress Score Assessed by the Study-Specific Acute Trauma Stress Questionnaire From T0 to T1
Ramy czasowe: From day 1 to approximately 24 hours after admission.
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Change in overall stress level between the initial Emergency Department assessment and approximately 24 hours after hospital admission among hospitalized participants.
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From day 1 to approximately 24 hours after admission.
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Change in Dominant Sources of Stress Assessed by the Study-Specific Acute Trauma Stress Questionnaire From T0 to T1
Ramy czasowe: From day 1 to approximately 24 hours after admission.
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Change in the most important patient-reported sources of stress between the initial assessment and approximately 24 hours after admission.
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From day 1 to approximately 24 hours after admission.
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Correlation Between Overall Stress Score and Patient-Reported Information and Understanding Score
Ramy czasowe: At day 1 and, for hospitalized participants, approximately 24 hours after admission.
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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.
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Procesy patologiczne
- Atrybuty choroby
- Stany patologiczne, oznaki i objawy
- Sytuacje awaryjne
- Rany i urazy
- Jakość opieki zdrowotnej, dostęp i ocena
- Techniki śledcze
- Metody epidemiologiczne
- Lecznictwo
- Zbieranie danych
- Mechanizmy oceny opieki zdrowotnej
- Jakość opieki zdrowotnej
- Zdrowie publiczne
- Środowisko i zdrowie publiczne
- Kontrola zachowania
- Unieruchomienie
- Ankiety i kwestionariusze
- Ograniczenie, fizyczne
Inne numery identyfikacyjne badania
- PozegaBolnica
- Ur.broj: 02-7/3-3/2-2-2026 (Inny identyfikator: Ethics Committee of the General County Hospital Požega)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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