| 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
|
|
|
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
|
|
|
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 ICUâ€
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
|