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CTRI Number  CTRI/2025/03/082367 [Registered on: 17/03/2025] Trial Registered Prospectively
Last Modified On: 10/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   How the time spent in the ICU influences a patients stress levels and their ability to perform daily activities once they are out. 
Scientific Title of Study   Impact of duration of icu stay on anxiety and functional status among patients admitted in icu:An 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  Rani c reji 
Designation  post graduate student 
Affiliation  NITTE INSTTUTE OF PHYSIOTHERAPY 
Address  Department of physiotherapy NITTE institute of physiotherapy, NITTE (deem to be university), Derlakatte

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8590074230  
Fax    
Email  ranicreji17@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mrs Abeeshna ashok 
Designation  Assistant professor 
Affiliation  NITTE INSTTUTE OF PHYSIOTHERAPY 
Address  Department of physiotherapy NITTE institute of physiotherapy, NITTE (deem to be university), DERLAKKATTE, KARNATAKA

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9895724380  
Fax    
Email  abeeshnaashok@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Abeeshna ashok 
Designation  Assistant professor 
Affiliation  NITTE INSTTUTE OF PHYSIOTHERAPY 
Address  Department of physiotherapy NITTE institute of physiotherapy, NITTE (deem to be university), DERLAKKATTE, KARNATAKA

Dakshina Kannada
KARNATAKA
575018
India 
Phone  09895724380  
Fax    
Email  abeeshnaashok@nitte.edu.in  
 
Source of Monetary or Material Support  
Department of physiotherapy, room number 20, Second base division, Justice K.S Hedge charitable hospital, Medical science complex, Deralakatte, Mangaluru 575018 Dakshina kannada KARNATAKA  
 
Primary Sponsor  
Name  Nitte Deemed to be university 
Address  Department of physiotherapy, Room number 20, second base division, NITTE institute of physiotherapy, NITTE (deem to be university), DERLAKKATTE,MANGALURU, KARNATAKA 575018,INDIA 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rani C Reji  Justice K S Hegde, Hospital  CTVS 3rd Floor Room Number 2
Dakshina Kannada
KARNATAKA 		 08590074230

ranicreji17@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Intitutional Ethics Committe of NITTE Institute of physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nill  nill 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients admitted to the ICU who had an ICU stay of more than 2 to 3 days.
Adults aged between 18-65 years.
Patients with GCS more than 7.
Both male and female patients.
Patients or their legal representatives must provide informed consent to participate in the study.
Patients must be able to communicate verbally or through an alternative means to participate in assessments (if applicable).
 
 
ExclusionCriteria 
Details  Patients with pre-existing severe cognitive impairments.
Severe Psychiatric Conditions.
Hemodynamically unstable patients.
Patients require isolation.
Patients admitted to the ICU following elective surgeries.
Patients who are unable to perceive English, Kannada, or Malayalam.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Barthel index  Barthel index will be assessed in baseline for the functional status 
 
Secondary Outcome  
Outcome  TimePoints 
HADS(hospital anxiety depression scale)  HADS will be assessed in baseline for the anxiety level 
 
Target Sample Size   Total Sample Size="121"
Sample Size from India="121" 
Final Enrollment numbers achieved (Total)= "121"
Final Enrollment numbers achieved (India)="121" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/03/2025 
Date of Study Completion (India) 10/01/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 10/01/2026 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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   ICU survivors often experience long-term challenges such as impaired functional status, anxiety, and reduced health-related quality of life (HRQOL), extending beyond those who underwent mechanical ventilation. Understanding these impacts is crucial for developing targeted rehabilitation strategies. This study aims to assess anxiety levels using the Hospital Anxiety and Depression Scale (HADS) and functional status using the Barthel Index (BI), both of which are well-validated tools for evaluating post-ICU recovery. HADS will help identify patients struggling with anxiety and depression, allowing for early psychological interventions, while the BI will assess their ability to perform daily activities, guiding the development of personalized rehabilitation programs. Ethical clearance will be obtained, and necessary permissions will be sought before recruiting eligible patients based on predefined criteria. After informed consent, a one-time assessment will be conducted, and the collected data will undergo statistical analysis. The findings will help design targeted interventions that enhance physical recovery, reduce psychological distress, and improve overall post-ICU quality of life. 
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