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CTRI Number  CTRI/2024/10/074644 [Registered on: 03/10/2024] Trial Registered Prospectively
Last Modified On: 03/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [mixed methods]  
Study Design  Single Arm Study 
Public Title of Study   developing an education method using actors as patients to train physiotherapy students in safely mobilizing patients admitted in Intensive care unit and evaluating the skills and confidence gained using check list  
Scientific Title of Study   Development, Implementation, Evaluation of Module on “Safe Mobilization” in ICU using standardized patients in Physiotherapy education  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mariya Jiandani 
Designation  Associate Professor  
Affiliation  Physiotherapy School and Centre Seth G S Medical College and KEMH  
Address  Room No 16, Ground Floor, CVTC Building, Physiotherapy School and Centre, Seth G S Medical College and KEM Hospital, Parel East, Mumbai - 400012 Mumbai MAHARASHTRA

Mumbai
MAHARASHTRA
400012
India 
Phone  09820101196  
Fax    
Email  mpjiandani@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mariya Jiandani 
Designation  Associate Professor  
Affiliation  Physiotherapy School and Centre Seth G S Medical College and KEMH  
Address  Room No 16, Ground Floor, CVTC Building, Physiotherapy School and Centre, Seth G S Medical College and KEM Hospital, Parel East, Mumbai - 400012 Mumbai MAHARASHTRA

Mumbai
MAHARASHTRA
400012
India 
Phone  09820101196  
Fax    
Email  mpjiandani@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mariya Jiandani 
Designation  Associate Professor  
Affiliation  Physiotherapy School and Centre Seth G S Medical College and KEMH  
Address  Room No 16, Ground Floor, CVTC Building, Physiotherapy School and Centre, Seth G S Medical College and KEM Hospital, Parel East, Mumbai - 400012 Mumbai MAHARASHTRA

Mumbai
MAHARASHTRA
400012
India 
Phone  09820101196  
Fax    
Email  mpjiandani@gmail.com  
 
Source of Monetary or Material Support  
Physiotherapy School and Centre Seth GSMC and KEMH, Parel East, Mumbai 12, INDIA 
 
Primary Sponsor  
Name  Physiotherapy School & Centre Seth G S Medical College & KEMH  
Address  Room No 16 Ground Floor CVTC Building Parel East Mumbai 400012 Mumbai MAHARASHTRA 400012 
Type of Sponsor  Research institution and hospital 
 
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 Mariya Jiandani  Physiotherapy School and Centre, Seth GS Medical College and KEM Hospital  Cardiovascular and pulmonary rehabilitation department Cardiovascular and Thoracic centre Room No 16, Ground Floor, CVTC Building,Opp gate 3 Seth G S Medical College and KEM Hospital, Parel East, Mumbai - 400012 MAHARASHTRA
Mumbai
MAHARASHTRA 
09820101196

mpjiandani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Seth GS Medical Institutional Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Not Applicable 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  NONE  NONE 
Intervention  standardized patients  Teaching safe mobilization using standardized patients weekly one session per week for four weeks.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Educators (Faculty) teaching physiotherapy in the ICU with 2 years’ teaching experience
2.ICU clinical physiotherapist or clinicians
3.Interns, postgraduate students of cardiorespiratory specialty of either sex and more than, with work experience in the ICU
4.Medical or physiotherapy education unit coordinators with expertise in health education technology
5.More than 18 years of age and less than 75
6.Both males and females
7.Able to read and write English
8.Willing to consent to participation.
 
 
ExclusionCriteria 
Details  Not willing to consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
number of competencies at baseline,Delphi agreement at baseline, 4 weeks and 8 weeks and Check list baseline and 4 weeks, Confidence baseline and four weeks and Faculty feedback  number of competencies at baseline,Delphi agreement at baseline, 4 weeks and 8 weeks and Check list baseline and 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Confidence baseline and four weeks and Faculty feedback  baseline and four weeks  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   24/10/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

The proposed Project titled "Development, Implementation, and Evaluation of a Module on ’Safe Mobilization in ICU’ using Standardized Patients in Physiotherapy Education" addresses a critical gap in current physiotherapy training, particularly within the intensive care setting. Recognizing the deficiency in practical training that integrates real-life complexities faced in ICUs, this project seeks to employ simulation-based learning—a pedagogical approach that has shown substantial benefits in medical and nursing education but remains underutilized in physiotherapy. This method will enable students to practice and refine their skills in a controlled environment, enhancing safety and efficacy before they engage with real patients.The specific task identified is “Mobilization in ICU”

The need for this project arises from the observation that traditional physiotherapy education, largely grounded in theoretical knowledge and conventional practical experiences, does not adequately prepare students for the high-stakes environment of ICUs. This was especially evident during the COVID-19 pandemic when physiotherapists from various specialties were required to treat critically ill patients, underscoring the urgent need for better preparatory training. By integrating  simulation techniques,such as standardized patients  the project aims to equip physiotherapy students with the critical decision-making and physical mobilization skills necessary for ICU settings, thereby reducing potential errors and improving patient outcomes.

The project will  be completed in three phases over two years, following the KERN six-step model for curriculum development. The first phase involves conducting a comprehensive needs analysis through literature reviews and focus group discussions with faculty and students. This phase aims to pinpoint existing educational gaps and define the specific competencies required for ICU physiotherapists. In the second phase, the curriculum module will be developed based on the competencies identified in Phase 1, utilizing a Delphi method to validate the content with subject experts and ICU clinicians. The third phase focuses on the implementation and rigorous evaluation of the developed module. This includes pilot testing with a select group of physiotherapy interns and subsequent evaluations to assess the effectiveness of the training. Feedback will be meticulously collected through various methods including pre-post tests, performance assessments with standardized patients, and comprehensive 360-degree feedback

 

 
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