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临床试验/CTRI/2025/06/089616
CTRI/2025/06/089616尚未招募不适用

Incidence and risk factors for post traumatic stress disorder in adult Trauma survivors admitted in intensive care unit : A prospective observational study

Intensive Care Unit1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2025年7月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
125
试验地点
1
主要终点
To determine the incidence of post-traumatic stress disorder in trauma patients admitted in intensive care unit.

研究概览

简要总结

INTRODUCTION

Survivors of trauma can experience long-term impacts on their physical and mental health, which can often compromise their daily functioning and quality of life, as well as that of their families [1-3]. Since the World Health Organisation (WHO) defines health as a state of complete physical, mental, and social well-being rather than just the absence of disease or infirmity [4], it is crucial to investigate the incidence and risk factors for health issues among trauma patients admitted to intensive care units.

Post-Traumatic Stress Disorder (PTSD) is a pervasive mental health condition that can significantly impact individuals who have experienced trauma. Among adult trauma survivors admitted to the Intensive Care Unit (ICU), the incidence of PTSD is a critical concern. This introduction aims to explore the prevalence and risk factors associated with the development of PTSD in this specific population. [5]Anxiety, depression, and post-traumatic stress disorder are examples of psychiatric symptoms (PTSD). The latter is an extremely debilitating psychopathology that is commonly experienced by individuals who are exposed to trauma mass and war violence, terrorism, natural and man-made disasters, child abuse, or ICU stays; however, high rates are also noted following these events, as well as in COVID-19 survivors and their families.

ICU admissions often involve life-threatening situations, exposing individuals to extreme stressors that may precipitate psychological distress. Understanding the incidence of PTSD in adult trauma survivors within the ICU setting is crucial for developing targeted interventions and improving overall patient outcomes.[6]

 Several factors contribute to the heightened vulnerability of ICU patients to PTSD. The nature of traumatic injuries, the severity of medical conditions, and prolonged exposure to life-saving interventions create a complex interplay of physical and psychological stressors. This sets the stage for the emergence of PTSD symptoms, including intrusive thoughts, hyperarousal, and avoidance behaviors.[7]

Risk factors associated with the development of PTSD in ICU-admitted adult trauma survivors encompass both pre-existing and ICU-specific variables. Pre-existing factors may include a history of mental health disorders, prior trauma exposure, and individual resilience levels. ICU-specific variables involve the duration of mechanical ventilation, length of ICU stay, and the presence of delirium, all of which contribute to the overall stress experienced during critical illness.

Furthermore, the socio-demographic profile of trauma survivors may influence PTSD risk. Age, gender, and socio-economic status play roles in shaping an individual’s resilience and coping mechanisms, influencing their susceptibility to PTSD following traumatic events.

Recognizing the multifaceted nature of PTSD risk in adult trauma survivors admitted to the ICU is imperative for healthcare professionals. By identifying high-risk individuals early in the ICU stay, targeted interventions can be implemented to mitigate the impact of trauma and potentially prevent the development of PTSD.

 In this study, the importance of understanding the incidence and risk factors associated with PTSD in adult trauma survivors admitted to the ICU. By exploring the complexities of this population’s experiences, healthcare providers can tailor interventions to address the unique challenges faced by ICU patients, ultimately improving mental health outcomes and enhancing overall quality of care.

Aim and Objectives

·        To determine the incidence of post traumatic stress disorder in trauma patients admitted in intensive care unit

·        To determine the risk factors leading to development of neuropsychiatric illness (PTSD)

Study setting :

The study will be conducted in Department of Anesthesiology, King George’s Medical University, Lucknow. After getting approval from institutional ethical committee, this prospective observational study will be carried out in various operation theater under department of  Anaesthesiology, King George’s Medical University, Lucknow.

Study duration : One and half year

Study design: Prospective observational study

Sample size:

Inclusion Criteria:

–     All adult trauma patients admitted in intensive care unit

–     Patient giving written informed consent will be taken

Exclusion criteria

·        Any psychiatric illness from before

·        Head injury

·        Not giving consent

Methodology:

After obtaining approval from the ethics committee of the university, a written informed consent from the patients will be obtained. Clinical information about ICU stay, laboratory data, and severity scores was digitally recorded and extracted using the Institutional electronic medical record. We considered “highest value” as the worst data during the ICU stay. All data were anonymized and saved in an electronic worksheet.

We will follow up the patient for 6 months.

OUTCOME MEASURES:

·        Incidence

·        Risk factors: physiological-Revised trauma score(RTS)

·        Combined: Trauma score and injury severity score (TRISS)

·        Combined: Revised injury severity classification combined version ll (RISC II)

·        Comorbidity

·        ICU stays

·        Sedation

·        Mean variation

   Statistical analysis:

SPSS latest available version and MS Excel will be use for statistical analysis of the data. Continuous variables conforming to a normal distribution will be expressed as mean  standard deviation. Counting data will be expressed as number and percentages. The ANOVA, unpaired t test or its non parametric equivalents will be used for within group analysis. The 2 test will used to compare the proportion data between the groups. Other appropriate statistical tests will be used. In all of the statistical analyses, P  0.05 will be considered to be statistically significant.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • All adults (age 18-60 years) trauma patients admitted in intensive care unit.

排除标准

  • Not willing to participate Head injury.

结局指标

主要结局

To determine the incidence of post-traumatic stress disorder in trauma patients admitted in intensive care unit.

时间窗: To determine the incidence of post-traumatic stress disorder in trauma patients admitted in intensive care unit.

次要结局

  • determine the risk factors leading to development of neuropsychiatric illness.(The DSM-5 rule, which use the PCL-5 instrument tool, states that PTSD is diagnosed when a respondent receives a score of 2 or higher, or a total sum score of 40.)

研究者

发起方
Intensive Care Unit
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Niranjan Goswami

King Georges Medical University Lucknow

研究点 (1)

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