| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G890||Central pain syndrome, |
|
|
Intervention / Comparator Agent
|
|
|
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. |