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CTRI Number  CTRI/2024/07/071521 [Registered on: 29/07/2024] Trial Registered Prospectively
Last Modified On: 16/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Participants will be asked to fill a questionnaire before and after a informative lecture ]  
Study Design  Single Arm Study 
Public Title of Study   To Assess the Change in Knowledge of people coming to Hospital Regarding Chronic Pain 
Scientific Title of Study   Assessment Of Change In Knowledge And Attitude Of Individuals Coming To Tertiary Care Hospital Regarding Chronic Pain – An Interventional 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  Dr Vidya S Lawand 
Designation  Pain Fellow 
Affiliation  Bharati Vidyapeeth(Deemed to be University) Medical College, Pune 
Address  Department of Anesthesiology and chronic Pain 3rd floor, OT Complex, Bharati Hospital and Research Centre, Bharati Vidyapeeth(Deemed to be University) Medical College, Pune

Pune
MAHARASHTRA
411043
India 
Phone  9763691558  
Fax    
Email  vidyalawand42@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Varshali Keniya 
Designation  Professor and Head  
Affiliation  Bharati Vidyapeeth(Deemed to be University) Medical College, Pune 
Address  Department of Anesthesiology and chronic Pain 3rd floor, OT Complex, Bharati Hospital and Research Centre, Bharati Vidyapeeth(Deemed to be University) Medical College, Pune

Pune
MAHARASHTRA
411043
India 
Phone  9881419089  
Fax    
Email  varshali.keniya@bharatividyapeeth.edu  
 
Details of Contact Person
Public Query  
Name  Dr Varshali Keniya 
Designation  Professor and Head  
Affiliation  Bharati Vidyapeeth(Deemed to be University) Medical College, Pune 
Address  Department of Anesthesiology and chronic Pain 3rd floor, OT Complex, Bharati Hospital and Research Centre, Bharati Vidyapeeth(Deemed to be University) Medical College, Pune

Pune
MAHARASHTRA
411043
India 
Phone  9881419089  
Fax    
Email  varshali.keniya@bharatividyapeeth.edu  
 
Source of Monetary or Material Support  
Bharati Hospital and Research Centre, Bharati Vidyapeeth (Deemed to be University), Medical College, Katraj, Pune 
 
Primary Sponsor  
Name  Dr Vidya S Lawand 
Address  Department of Anesthesiology and chronic Pain 3rd floor, OT Complex, Bharati Hospital and Research Centre, Bharati Vidyapeeth(Deemed to be University) Medical College, Pune India 411043 
Type of Sponsor  Other [Self Sponsored] 
 
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 Vidya S Lawand  Bharati Hospital and Research Centre  Department of Anesthesiology and Chronic Pain 3rd floor, OT Complex, Bharati Vidyapeeth(Deemed to be University) Medical College
Pune
MAHARASHTRA 		 9763691558

vidyalawand42@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Bharati Vidyapeeth (Deemed to be University) Medical College, Pune)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Creating awareness amongst patients relatives or accompanying person coming to the hospital  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Informative Awareness Lecture  A PRE test will be administered to the participants following which a Lecture will be delivered to the participants by a chronic pain physician regarding knowledge on chronic pain and benefits of timely treatment followed by a POST test to the participants 
Comparator Agent  Not Applicable   As this is a single arm study and same participants will be reassessed after the informative lecture has been given there is no comparing agent/arm 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Relatives or accompanying individuals of the patient coming to the hospital 
 
ExclusionCriteria 
Details  Participant refusal 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess if the information provided by a chronic pain physician leads to a perceptible increase in information and change in attitude of the participant assessed   At Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the knowledge & attitude of general public towards chronic pain
2. To formulate a questionnaire regarding awareness & options available for chronic pain relief. 		 At Baseline 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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
Modification(s)  		 Phase 3 
Date of First Enrollment (India)   15/08/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   This study aims to assess the change in level of knowledge and attitude of people regarding chronic pain with the help of a informative lecture by experts in the field , thus help in improving patient outcomes. 
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