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CTRI Number  CTRI/2025/06/089616 [Registered on: 26/06/2025] Trial Registered Prospectively
Last Modified On: 25/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Incidence and risk factors for post traumatic stress disorder in adult Trauma survivors admitted in intensive care unit  
Scientific Title of Study   Incidence and risk factors for post traumatic stress disorder in adult Trauma survivors admitted in intensive care unit : A prospective observational study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Niranjan Goswami 
Designation  Junior Resident 
Affiliation  King Georges Medical University Lucknow 
Address  Department of Anaesthesiology, Gandhi Memorial and associated hospital King Georges Medical University, Lucknow
Chowk Shahmina Road Uttar Pradesh
Lucknow
UTTAR PRADESH
226003
India 
Phone  9476863623  
Fax    
Email  niranjangoswami486@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Monica Kohli 
Designation  Professor and Head 
Affiliation  King Georges Medical University Lucknow 
Address  Department of Anaesthesiology, Gandhi Memorial and associated hospital King Georges Medical University, Lucknow
King Georges Medical University, Lucknow
Lucknow
UTTAR PRADESH
226003
India 
Phone  9839041228  
Fax    
Email  kohli.mona@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Monica Kohli 
Designation  Professor and Head 
Affiliation  King Georges Medical University Lucknow 
Address  Department of Anaesthesiology, Gandhi Memorial and associated hospital King Georges Medical University, Lucknow
King Georges Medical University, Lucknow

UTTAR PRADESH
226003
India 
Phone  9839041228  
Fax    
Email  kohli.mona@gmail.com  
 
Source of Monetary or Material Support  
Intensive care unit Department of Anaesthesiology and Trauma ventilatory unit King Georges Medical University shahmina road chowk Lucknow 
 
Primary Sponsor  
Name  Intensive Care Unit 
Address  Department of Anaesthesiology and Trauma ventilatory unit King Georges Medical University shahmina road chowk Lucknow 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Monica Kohli  Intensive Care Unit   Department of Anaesthesiology, Gandhi Memorial and associated hospital King Georges Medical University, Lucknow Chowk Shahmina Road Uttar Pradesh
Lucknow
UTTAR PRADESH 
9839041228

kohli.mona@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T07||Unspecified multiple injuries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All adults (age 18-60 years) trauma patients admitted in intensive care unit. 
 
ExclusionCriteria 
Details  Not willing to participate
Head injury
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To determine the incidence of post-traumatic stress disorder in trauma patients admitted in intensive care unit.  To determine the incidence of post-traumatic stress disorder in trauma patients admitted in intensive care unit. 
 
Secondary Outcome  
Outcome  TimePoints 
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. 
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. 
 
Target Sample Size   Total Sample Size="125"
Sample Size from India="125" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  


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.

 
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