| CTRI Number |
CTRI/2024/12/078824 [Registered on: 31/12/2024] Trial Registered Prospectively |
| Last Modified On: |
16/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Manikin-based Ultrasound-Guided Precision Needling (MUGPN) workshop in improving Anesthesia post-graduate students knowledge and skill |
|
Scientific Title of Study
|
Effectiveness of a Manikin-based Ultrasound-Guided Precision Needling (MUGPN) workshop in improving Anesthesia post-graduate students knowledge and skills: A long-term clinical performance evaluation study. |
| Trial Acronym |
MUGPN |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AIIMSA2291/7.10.2024 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhishek Nagarajappa |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Anesthesiology, Pain Medicine & Critical Care.
Room No. 5, Porta Cabin, 4th Floor, OLD ENT OPD, WARD Block, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
8587970180 |
| Fax |
|
| Email |
abhishek.nagarajappa@aiims.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Abhishek Nagarajappa |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Anesthesiology, Pain Medicine & Critical Care.
Room No. 5, Porta Cabin, 4th Floor, OLD ENT OPD, WARD Block, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
8587970180 |
| Fax |
|
| Email |
abhishek.nagarajappa@aiims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Abhishek Nagarajappa |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Anesthesiology, Pain Medicine & Critical Care.
Room No. 5, Porta Cabin, 4th Floor, OLD ENT OPD, WARD Block, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
8587970180 |
| Fax |
|
| Email |
abhishek.nagarajappa@aiims.edu |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, Pain Medicine & Critical Care, Teaching Block, AIIMS New Delhi-110029 |
| Skills-Learning & Telemedicine (SET Facility), 2nd Floor, Convergence Block, AIIMS New Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
AII India Institute of Medical Sciences |
| Address |
AIIMS, Ansari Nagar
New Delhi-110029. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Anesthesiology Pain Medicine Critical Care |
Department of Anesthesiology, Pain Medicine & Critical Care, Teaching Block, AIIMS New Delhi-110029 |
| SkillsLearning Telemedicine SET Facility |
Skills-Learning & Telemedicine (SET Facility), 2nd Floor, Convergence Block, AIIMS New Delhi-110029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhishek Nagarajappa |
AIIMS New Delhi |
Department of Anesthesiology, Pain Medicine & Critical Care.
Room No. 5, Porta Cabin, 4th Floor, OLD ENT OPD, WARD Block, AIIMS, New Delhi
South
DELHI |
08587970180
abhishek.nagarajappa@aiims.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS, Institutional Ethics Committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Anaesthesia residents traininig on Mannequin |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Faculty-Led Manikin-Based Workshop |
Phase I: Manikin-Based Training & Evaluation in Simulation Lab
a. Pre-workshop assessment (Pre-test): All Participants will have to undergo a
pre-workshop assessment to test their baseline-
I. Knowledge: A standardized Multiple-Choice Question (MCQ) based test (to
evaluate baseline knowledge in ultrasound-guided needling techniques).
II. Skill: Cognitive and psychomotor assessment: An Objective Structured
Practical Examination (OSPE) (focusing on ultrasound-guided needle insertion
on manikins to assess pre-workshop practical skills and collection of data
debriefing sessions.
b. Question & Answer session: A 30-minute Q&A session will cover the basics of
ultrasound technology, needling techniques, and safety protocols.
c. Demonstration by Faculty: The faculty will demonstrate all skills on the
manikins in 30 minutes.
d. Faculty-supervised needling practice will be done on ultrasound-conducive
manikins for the next 60 minutes.
e. Post-Workshop assessment: All Participants will be given a post-workshop
assessment to test their Knowledge and Skills.
Phase II: Clinical Practice and Longitudinal Assessment Over the next year, students in both groups will be permitted to perform ultrasound-guided needling procedures on patients in a real clinical setting. All procedures will be supervised by experienced faculty, who will provide real-time feedback and ensure patient safety. Performance evaluations will be conducted using validated checklist-based scoring criteria for needle placement accuracy, procedural time, and image quality (Direct Observation of Procedural Skills-DOPS) (Appendix I) Confidence and Competency Evaluation: Students confidence and perceived competency through self-reported surveys will be done every 4 months for 3 such surveys. (Appendix-II) |
| Intervention |
Self-directed needling practice followed by feedback-debriefing session |
Phase I: Manikin-Based Training & Evaluation in Simulation Lab
a. Pre-workshop assessment (Pre-test): All Participants will have to undergo a pre-workshop assessment to test their baseline-
I. Knowledge: A standardized Multiple-Choice Question (MCQ) based test (to evaluate baseline knowledge in ultrasound-guided needling
techniques)
II. Skill: Cognitive and psychomotor assessment: Participants will be provided with an Objective Structured Practical Examination (OSPE) on
3 stations of needle navigation.
b. Question & Answer session: A 30-minute Q&A session will cover the basics of ultrasound technology, needling techniques, and safety
protocols.
c. Feedback and debriefing sessions by faculty will be conducted for 30 minutes for all, according to performance on pre-test stations
(using pictures and videos taken during the pre-test stations).
d. Participant-based (unsupervised) needling practice will be followed on the ultrasound conducive manikins for the next 60 minutes.
e. Post-Workshop assessment: All Participants will be given a post-workshop assessment to test their Knowledge and Skills.
Phase II: Clinical Practice and Longitudinal Assessment
Over the next year, students in both groups will be permitted to perform ultrasound-guided needling procedures on patients in a real clinical setting. All procedures will be supervised by experienced faculty, who will provide real-time feedback and ensure patient safety. Performance evaluations will be conducted using validated checklist-based scoring criteria for needle placement accuracy, procedural time, and image quality (Direct Observation of Procedural Skills-DOPS) (Appendix I)
Confidence and Competency Evaluation:
Students confidence and perceived competency through self-reported surveys will be done every 4 months for 3 such surveys. (Appendix-II)
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
a. First- and second-year anesthesia postgraduate residents
b. No prior ultrasound-guided needling experience. |
|
| ExclusionCriteria |
| Details |
a. First- and second-year anesthesia postgraduate residents
b. No prior ultrasound-guided needling experience. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome will be the improvement in knowledge and skills, as demonstrated by post-workshop assessments, including the MCQ-based test and OSPE. |
2 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes will focus on long-term clinical performance and patient. outcomes, such as the success rates and complication rates of ultrasound-guided procedures performed by the participants. It will also include participant satisfaction with the workshop and their confidence in performing USG-guided procedures, as measured by the post-workshop surveys. |
4, 8, & 12 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/01/2025 |
| 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)
|
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
|
Ultrasound-guided needling techniques have revolutionized the practice of medical education, offering enhanced precision, safety, and efficacy. For participants, becoming proficient in these techniques is crucial for academic achievement and their future clinical practice. Traditional methods of teaching these skills, however, often fall short of providing the hands-on experience necessary for proficiency. Manikin-based ultrasound needling workshops offer a promising approach to bridging this gap by providing a controlled environment for students to practice and refine their USG needling techniques. By replicating clinical scenarios in a safe controlled environment, these workshops allow students to develop and refine their ultrasound-guided needling skills without the pressure of a real-life clinical setting. This study aims to evaluate the effectiveness of an active, faculty-led, manikin-based skill training workshop compared to self-directed needling practice with feedback and debriefing sessions. The focus will be on participants’ procedural skills on manikins and their proficiency in performing ultrasound-guided needling techniques. By comparing these two educational approaches, the study seeks to identify the most effective method for enhancing both technical proficiency and learner confidence. The study will conduct a comprehensive performance evaluation over an extended period to assess whether the benefits of these workshops translate into improved clinical outcomes, thereby affirming their role as an essential component of medical education. The overall purpose of the study is to evaluate the effectiveness of various teaching methods in enhancing the knowledge and skills of participants, with a particular focus on ultrasound-guided precision needling techniques. Additionally, to evaluate the efficiency of faculty and student time utilization during these teaching sessions, ensuring that the methods employed are both effective and time-efficient for better learning outcomes.
Objective: To evaluate the effectiveness of an active Faculty-led manikin-based skill training workshop compared to self-directed needling practice with feedback-debriefing sessions on anesthesia post-graduate students’ procedural skills. To evaluate the long-term clinical performance of the students and the patient outcomes. To evaluate student confidence & perceived competence on ultrasound needling techniques
Yes, It is an educational trial followed by clinical applications |