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Stress in Trauma Patients in Triage Categories 3-5

3 сентября 2026 г. обновлено: 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.

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Наблюдательный

Регистрация (Оцененный)

300

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Места учебы

  • Хорватия
      • Požega, Хорватия, 34000
        • OŽB Požega
        • Контакт:
          • Director of the General County Hospital Požega., MD, PHD
          • Номер телефона: 003834254506
          • Электронная почта: ivan.vukoja@pozeska-bolnica.hr
        • Контакт:

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Метод выборки

Невероятностная выборка

Исследуемая популяция

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.

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Когорты и вмешательства

Группа / когорта
Вмешательство/лечение
Triage Category 3
Clinically stable adult trauma patients classified as triage category 3 after initial emergency assessment.
Другой: 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.
Другой: 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.
Другой: 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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Overall Acute Stress Level
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Individual Sources of Stress at T0
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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.

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Gabriela Katharina Pomper

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 сентября 2026 г.

Первичное завершение (Оцененный)

31 августа 2028 г.

Завершение исследования (Оцененный)

31 августа 2028 г.

Даты регистрации исследования

Первый отправленный

29 августа 2026 г.

Впервые представлено, что соответствует критериям контроля качества

3 сентября 2026 г.

Первый опубликованный (Действительный)

10 сентября 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

10 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

3 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

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

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Описание плана 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.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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