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CTRI Number  CTRI/2022/01/039345 [Registered on: 12/01/2022] Trial Registered Prospectively
Last Modified On: 11/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective- Qualitative study 
Study Design  Other 
Public Title of Study   Development of a pain management system for the improvisation pain management practice  
Scientific Title of Study   Development of pain management stewardship program and evaluation of its impact on pain management practice in a tertiary care hospital 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  JERIN JAMES 
Designation  PhD Research Scholar 
Affiliation  MANIPAL COLLEGE OF PHARMACEUTICAL SCIENCES 
Address  Dept. of Pharmacy Practice Manipal College of Pharmaceutical sciences, Manipal 576 104

Udupi
KARNATAKA
576 104
India 
Phone  9539059096  
Fax    
Email  jerin.james@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajesh V 
Designation  Assistant Professor – Selection Grade 
Affiliation  Manipal College of Pharmaceutical sciences 
Address  Dept. of Pharmacy Practice Manipal College of Pharmaceutical sciences, Manipal 576 104

Udupi
KARNATAKA
576104
India 
Phone  9538417313  
Fax    
Email  Rajesh.v@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Rajesh V 
Designation  Assistant Professor – Selection Grade 
Affiliation  Manipal College of Pharmaceutical sciences 
Address  Dept. of Pharmacy Practice Manipal College of Pharmaceutical sciences, Manipal 576 104

Udupi
KARNATAKA
576104
India 
Phone  9538417313  
Fax    
Email  Rajesh.v@manipal.edu  
 
Source of Monetary or Material Support  
Dr.TMA PAI FELLOWSHIP,MANIPAL ACADEMY OF HIGHER EDUCATION, MANIPAL 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [No Sponsor] 
 
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 
JERIN JAMES  KASTURBA HOSPITAL, MAHE, MANIPAL  DEPARTMENT OF PHARMACY PRACTICE,MANIPAL COLLEGE OF PHARMACEUTICAL SCIENCES, KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL, MAHE, MANIPAL,UDUPI, KARNATAKA-576104
Udupi
KARNATAKA 
09539059096

jerin.james@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL INSTITUTIONAL ETHICS COMMITTE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G890||Central pain syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  patients who experiences pain (age > 18)
Physicians who involved in the pain management,
Nursing staff who involved in the pain management,  
 
ExclusionCriteria 
Details  Those who are unwilling to participate in the study, patients with incomplete case records, patients who are not able to give consent. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Harmonization and validation of uniform pain management system for an Indian hospital setting.  0,6,18,24,30 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="317"
Sample Size from India="317" 
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)   20/01/2022 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary  

Development of pain management stewardship program and evaluation of its impact on pain management practice in a tertiary care hospital.

Background: The prevalence of Chronic pain in India is 19.3% and in the upcoming two decades the prevalence may significantly rise, adversely affecting the global health level, man-hours, and total national economy. Pain management is a vital part of healthcare services. Most physicians did not assess the types of pain and did not use any tools to evaluate the intensity of pain. Appropriate documentation of pain is one of the important steps in pain management. The proper assessment of pain is very important to begin and assess the effectiveness of pain treatments.  A survey across 10 Asian countries to assess the attitude towards cancer pain management resulted that, 49.5% of patients reported that no scale was used for assessing the pain and 49.7% of physician reported poor pain assessment as an important barrier to pain therapy.  Poor pain assessment and documentation resulted in undertreated pain; it also happens in Indian hospitals. We aimed to identify, harmonize and validate a standard pain assessment tool for the Indian health care setting.

Objectives:

·  To evaluate the practice of pain management: Assess the current practice of pain assessment and documentation, Assess the clinical decision-making process of analgesics use, Evaluate the usage Pattern of analgesic, Assess the barriers faced by health care providers in the pain management practice.

· Harmonization of brief pain inventory (BPI) for the Indian healthcare setting: Qualitative study (physician, In patient, In nurses)

·    Expert review

     Psychometric testing of BPI

Methodology:

Phase 1 (Baseline survey- 6 months)

· Predesigned proforma will be developed and validated with the help of pain experts. Details regarding the current practices of pain assessment and documentation, clinical decision-making process of analgesics use, usage pattern of analgesics will be evaluated by screening the case records of the patients, through interviews and the data will be recorded in the pre-designed proforma.

Phase 2 (Assessing barriers- 6 months -Parallel to phase 1)

Develop and validate questionnaire for the evaluation of barriers faced by the health care providers in the pain management practice with the help of pain expert and healthcare providers. The questionnaire will be rolled-out to the healthcare providers and their response will be recorded.

·   Phase 3 – Harmonization of Brief pain inventory (1 year)

Participants will purposively recruit and interviewed in-depth. The in-depth interviews will be transcribed and coded using NVivo software. The interview transcripts will be analysed using the reflexive thematic analysis. Participant who are experiencing pain and those who are involved in the pain management will explore the concepts defined by each item in the BPI scale from their perspective. Considering the current COVID-19 pandemic, face to face interviews or telephonic conversations will be considered depending upon the convenience of the participants.

Phase 4 (3 months)- Expert review

·  Each result obtained from the Phase 1,2,3 will be brought together and evaluated, reviewed, and revised. Nominal group discussion technique will used to evaluate the concept, content, experiential and semantic.

Phase 5(3 months)- psychometric testing

The psychometric properties of the questionnaire including quantitative and qualitative face validity, quantitative and qualitative content validity, construct validity and reliability of the tool will be assessed.

Outcome measures: harmonization and validation of uniform pain management system for an Indian hospital setting.

 


 
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