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CTRI Number  CTRI/2022/04/042247 [Registered on: 28/04/2022] Trial Registered Prospectively
Last Modified On: 27/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Traumatic events, relationship with emotions and quality of life in persons with chronic pain 
Scientific Title of Study   Trauma antecedents, alexithymia and quality of life in persons with primary and secondary chronic pain 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Qurat ul Ain 
Designation  M.Phil Clinical Psychology (Year II) 
Affiliation  Government Medical College and Hospital, Sector 32, Chandigarh 
Address  Room Number 311, Mental Health Institute, Department of Psychiatry, sector 32, Chandigarh

Chandigarh
CHANDIGARH
160047
India 
Phone    
Fax    
Email  qbazaz33@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manoj K Bajaj 
Designation  Associate Professor, Clinical Psychology,  
Affiliation  Government Medical College and Hospital, Sector 32, Chandigarh 
Address  Department of Psychiatry, Room No 1220/Typ-IV/32B, GMCH Campus

Chandigarh
CHANDIGARH
160047
India 
Phone  8558890803  
Fax    
Email  mkbajaj@gmail.com  
 
Details of Contact Person
Public Query  
Name  Qurat ul Ain 
Designation  M.Phil Clinical Psychology (Year II) 
Affiliation  Government Medical College and Hospital, Sector 32, Chandigarh 
Address  Room Number 4219, OPD, Block B, Department Of Psychiatry, Government Medical College and Hospital, Chandigarh
311 Mental Health Institute, sector 32, Chandigarh
Chandigarh
CHANDIGARH
160047
India 
Phone    
Fax    
Email  qbazaz33@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  Government Medical College and Hospital 
Address  Sector 32, Chandigarh 
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 
Dr Sukanya Mitra  Government Medical College and Hospital, Sector 32, Chandigarh  Pain and PAC Clinic, First Floor, Department of Anaesthsia, Block B, 1111/32B, GMCH Campus
Chandigarh
CHANDIGARH 		 9646121521

drsmitra12@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committeeee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G894||Chronic pain syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Individuals having chronic pain for more than 3 months
Age Range: 20-55 years
Education Level: 10th and above
Any Gender 
 
ExclusionCriteria 
Details  Individuals with major psychiatric disorders such as psychosis, bipolar affective disorders, substance dependence disorder (except nicotine & caffeine), obsessive compulsive disorder, eating disorders

Individuals with a history of migraine disorder

Individuals having co-morbid medical conditions requiring treatment or undergoing
treatment 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Trauma Antecedents in Chronic Pain  At the end of Data Collection (3 months) 
 
Secondary Outcome  
Outcome  TimePoints 
Alexithymia and Quality of Life  At the end of data collection (3 months) 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   08/05/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  08/05/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 01-04-2023 and end date provided 16-05-2023?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Chronic pain is an emerging public health problem impacting large number of individuals but is poorly understood in terms of mechanisms and causes. Very few studies have been conducted that study the role of trauma antecedents in the development or maintenance of chronic pain. There is enough literature that establishes linkages between trauma, alexithymia and chronic pain separately but there is a need to study them together. Almost all previous research has limited itself to either a specific gender, condition, culture and the variables have been studied only in pairs. There exists no published study that looks at the association between all three variables in chronic pain conditions. The present study aims to bridge that gap by exploring associations among all the three variables and comparing them across the two conditions. According to the literature review conducted, almost all studies have focused on specific chronic pain disorders due to increased heterogeneity. However, recent discourse around chronic pain points towards a classification of these syndromes as over-arching chronic pain as they might have similar etiology and clinical presentations. Thus, there is a need to evaluate chronic pain as a distinct, independent condition. There is also a deficit in research studies that compare primary chronic pain conditions to other kinds of chronic pain. The current study can have treatment implications as traumatic histories, alexithymia and quality of life are important domains for a holistic assessment and significantly determine the course of treatment.   
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