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CTRI Number  CTRI/2024/05/067832 [Registered on: 24/05/2024] Trial Registered Prospectively
Last Modified On: 21/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Relation of students use of techniques for handling traumatic experiences and their quality of life  
Scientific Title of Study   Association of Coping Strategies and Quality of Life with Lifetime Traumatic Events Among University Students: A Cross-Sectional 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  Harshitha 
Designation  Post graduate student 
Affiliation  Nitte Institute of Physiotherapy 
Address  Department of Physiotherapy Room No.20 second base Division, Nitte Institute of Physiotherapy NIITE (Deemed to be University) Deralakatte, Mangaluru , KARNATAKA INDIA

Dakshina Kannada
KARNATAKA
575018
India 
Phone  7022131175  
Fax    
Email  harshithabcrd31@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Jayesh Chandran 
Designation  Assistant professor 
Affiliation  Nitte Institute of Physiotherapy 
Address  Department of Physiotherapy Room No.20 second base Division, Nitte Institute of Physiotherapy NIITE (Deemed to be University) Deralakatte, Mangaluru , KARNATAKA INDIA

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9383443710  
Fax    
Email  jayesh.nairpt@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Mr Jayesh Chandran 
Designation  Assistant professor 
Affiliation  Nitte Institute of Physiotherapy 
Address  Department of Physiotherapy Room No.20 second base Division, Nitte Institute of Physiotherapy NIITE (Deemed to be University) Deralakatte, Mangaluru , KARNATAKA INDIA

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9383443710  
Fax    
Email  jayesh.nairpt@nitte.edu.in  
 
Source of Monetary or Material Support  
Nitte Institute of Physiotherapy(NITTE Deemed to be university), Deralakatte, Mangaluru , Karnataka India-575018 
 
Primary Sponsor  
Name  Nitte Institute of PhysiotherapyNITTE Deemed to be university 
Address  Nitte Institute of Physiotherapy, Deralakatte, Mangaluru, Karnataka, India -575018 
Type of Sponsor  Other [Constitutent Physiotherapy Institute of NITTE ( Deemed to be University)] 
 
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 
Dr Jayesh Chandran  Student wellness center, Nitte Institute of Physiotherapy  Department of Physiotherapy Room No.20 second base Division, Nitte Institute of Physiotherapy NIITE (Deemed to be University) Deralakatte, Mangaluru , KARNATAKA INDIA
Dakshina Kannada
KARNATAKA 		 9383443710

jayesh.nairpt@nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee 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: F431||Post-traumatic stress disorder (PTSD),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1. University students -18 to 30 years
2. Both males and females are included
3. Exposure to a minimum of one event of trauma in their lifetime screened by Brief Trauma Questionnaire
4. Should be able to read and understand English
 
 
ExclusionCriteria 
Details  1. Trauma which does not come under the Brief Trauma Questionnaire (BTQ)
2. Those who are not willing to participate in the study
3. Candidates who have answered ‘NO’ for the traumatic event
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Coping Inventory for Stressful Situations(CISS)  Once at the time of assessment 
 
Secondary Outcome  
Outcome  TimePoints 
World Health Organization Quality of Life Scale -Brief Version (WHOQOL-BREF)   Once at the time of assessment 
 
Target Sample Size   Total Sample Size="86"
Sample Size from India="86" 
Final Enrollment numbers achieved (Total)= "94"
Final Enrollment numbers achieved (India)="94" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2024 
Date of Study Completion (India) 24/12/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 24/12/2024 
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   PTSD is a condition marked by ongoing mental and emotional stress that follows a traumatic event or witnessing one. Research on traumatizing stress has typically concentrated on evaluating the psychological effects of a particular incident. Usually, a group that went through various horrific experiences, like the death of a loved one, sexual abuse as a child, or violent accidents. Avoidance, detachment, and suppression are examples of emotion-focused coping techniques that help manage emotional arousal and suffering brought on by the stressor without addressing the issue. The multifaceted concept of quality of life incorporates an individual’s subjective assessments of their physical, social, emotional, and cognitive functioning. There are limited studies that focus on coping strategies with lifetime traumatic events and also the relationship of avoidance, emotion, and problem-oriented coping with quality of life. Hence this study aims to find the relationship between the coping strategies and quality of life with the traumatic events among university students. 
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