- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Gabriela K Pomper, MD, PHD
- 전화번호: 003834254532
- 이메일: gabrielakatharina@pozeska-bolnica.hr
연구 장소
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Požega, 크로아티아, 34000
- OŽB Požega
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연락하다:
- Director of the General County Hospital Požega., MD, PHD
- 전화번호: 003834254506
- 이메일: ivan.vukoja@pozeska-bolnica.hr
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연락하다:
- Head of Emergency Department, MD
- 전화번호: 003834254804
- 이메일: matko.šperanda@pozeska-bolnica.hr
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Overall Acute Stress Level
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Individual Sources of Stress at T0
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- PozegaBolnica
- Ur.broj: 02-7/3-3/2-2-2026 (기타 식별자: Ethics Committee of the General County Hospital Požega)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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