Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Stress in Trauma Patients in Triage Categories 3-5

3 de setembro de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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 de estudo

Observacional

Inscrição (Estimado)

300

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
Triage Category 3
Clinically stable adult trauma patients classified as triage category 3 after initial emergency assessment.
Outro: 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.
Outro: 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.
Outro: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Overall Acute Stress Level
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Individual Sources of Stress at T0
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Gabriela Katharina Pomper

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de setembro de 2026

Conclusão Primária (Estimado)

31 de agosto de 2028

Conclusão do estudo (Estimado)

31 de agosto de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

29 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de setembro de 2026

Primeira postagem (Real)

10 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano 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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever