| CTRI Number |
CTRI/2026/03/106143 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Simulation Based Training for Medical Procedures, An Alternative to the Traditional See One, Do One Method |
|
Scientific Title of Study
|
Simulation-Enhanced Blended Learning Versus Traditional See One, Do One Approach for Training Clinical Procedural Skills: A Randomized Non-Inferiority Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Subodh Kumar |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AIIMS |
| Address |
Room No.- 434, Surgical Block, AIIMS,New Delhi
South DELHI 110029 India |
| Phone |
9793184350 |
| Fax |
|
| Email |
subodh.08aiims@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Subodh Kumar |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AIIMS |
| Address |
Room No.- 434, Surgical Block, AIIMS,New Delhi
South DELHI 110029 India |
| Phone |
9793184350 |
| Fax |
|
| Email |
subodh.08aiims@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Subodh Kumar |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AIIMS |
| Address |
Room No.- 434, Surgical Block, AIIMS,New Delhi
South DELHI 110029 India |
| Phone |
9793184350 |
| Fax |
|
| Email |
subodh.08aiims@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
All India Institute of Medical Sciences ,Ansari Nagar ,New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
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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 SUBODH KUMAR |
All India Institute of Medical Sciences |
Anaesthesia skill lab and operation theatre,AIIMS South DELHI |
9793184350
subodh.08aiims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
See One Do One |
Participant will see the procedure in operating room as done in traditional teaching. Participant will than do the procedure in operation theatre within 30 days of seeing the procedure |
| Intervention |
Simulation with blended learning |
Structured learning module of each procedure will be shown before through learning management system. This will be followed by skill practice in skill lab for 30 mins. Participant will than do procedure on patient within 30 days of skill practice |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Medical Professional Inclusion Criteria
1. Willingness to participate
2. Ability to complete both instructional and assessment components
Patient Inclusion Criteria
1.Adult patients aged 18 to 65 years.
2.Patients scheduled for elective surgical or diagnostic procedures in which one or more of the following procedures are indicated as part of routine standard of care:
oIntravenous cannulation
oArterial puncture for blood gas analysis
oAirway management, including endotracheal intubation or laryngeal mask airway (LMA) insertion
3.Patients undergoing procedures under general anaesthesia or monitored anaesthesia care, in accordance with established institutional protocols.
4.Patients who have received a Patient Information Sheet detailing the study objectives and the involvement of supervised trainees, and who have provided written informed consent for participation.
5.Patients deemed clinically appropriate for trainee-performed procedures, as determined by the supervising consultant anaesthesiologist, with no anticipated increase in risk compared with routine practice.
|
|
| ExclusionCriteria |
| Details |
1.Refusal to participate or inability to provide informed consent.
2.Patients requiring emergency or urgent interventions, where trainee involvement may compromise timely clinical management.
3.Patients classified as ASA physical status III or higher.
4.Presence of a known or anticipated difficult airway, including but not limited to Mallampati class III or IV, limited mouth opening, cervical spine instability, or prior documentation of difficult intubation.
5.History of multiple unsuccessful attempts at intravenous cannulation or arterial puncture, or presence of conditions that significantly increase procedural risk, including:
oSevere peripheral vascular disease
oKnown coagulopathy or bleeding disorders
oLocal infection, inflammation, or trauma at the intended procedural site
6.Patients requiring advanced, non-routine, or rescue airway techniques beyond standard endotracheal intubation or LMA insertion.
7.Pregnant patients, due to altered physiological considerations and heightened ethical safeguards.
8.Patients with hemodynamic or cardiorespiratory instability, or those considered to be at high anaesthetic risk, as assessed by the attending anaesthesiologist.
9.Patients concurrently enrolled in another interventional clinical study involving procedural or anaesthetic outcomes, where participation could introduce confounding or additional risk.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare overall procedural performance between Simulation enhanced blended group and See One Do One groups using structured checklist-based assessment and global rating scales in simulated and clinical environments. |
During Procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess learner satisfaction, perceived confidence, and acceptability of BL versus SODO methods.
2. To explore the feasibility, engagement, and completion rates of the BL modules and skill-room peer practice compared with traditional clinical exposure
|
After procedure |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
31/03/2026 |
| 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
|
Mastery of clinical procedural skills is essential in medical practice, especially at various stages of training, and their acquisition is the core objectives. Conventional training methods, particularly the ’see one, do one’ (SODO) approach, remain widely used. In this model, learners first observe a procedure performed by an experienced clinician and then perform it themselves under supervision. Although effective, this approach has notable limitations, including restricted opportunities for repeated practice, variability in patient presentations, and inherent risks of patient harm when procedures are performed by novices (Facilitating flexible learning by replacing classroom time with an online learning environment: a systematic review of blended learning in higher education) (Mccutcheon et al., 2015) These concerns are underscored by ethical guidelines such as the Declaration of Helsinki, which emphasizes the necessity of informed consent and the minimization of risk in medical training involving human subjects. In conventional offline lectures, the predominant model of unidirectional knowledge delivery by instructors often limits the capacity to address students’ holistic learning needs. Conversely, entirely online teaching, even with advanced information technology integration, can leave learners with excessive autonomy and may compromise the consistency and quality of educational outcomes (Müller & Mildenberger, 2021). Blended learning along with simulation, combines cognitive domain with psychomotor domain of medical education, facilitating a more dynamic and interactive educational experience, (Li et al., 2025; Mccutcheon et al., 2015). Although blended learning has advanced rapidly, its optimal implementation strategies and measurable effectiveness remain subjects of debate. Evidence suggests that blended learning may enhance medical education (Rowe et al., 2012) and undergraduate procedural training programs by integrating cognitive outcomes, supporting individualized learning trajectories, and fostering greater learner confidence and self-efficacy compared with conventional teaching method (Lee et al., 2023). This approach aims to provide a comprehensive learning experience that caters to diverse learning styles and enhances the acquisition of essential clinical skills. In the realm of procedural training, particularly for complex tasks such as intravenous (IV) cannulation, arterial puncture for blood gas analysis, endotracheal tube (ETT) intubation, and supraglottic airway devices insertion, traditional methods such as SODO technique often used but recently come to scrutiny due to associated patient harm. Blended Learning with simulation offers a potential solution by providing a flexible and scalable model that incorporates digital learning and simulation to replace traditional training. Simulation-based education (SBE) is widely acknowledged for its effectiveness in enhancing procedural competencies, offering learners a risk-free environment to practice clinical skills. Evidence indicates that SBE not only improves technical proficiency but also increases learner confidence and facilitates repeated practice, which is often constrained in real-world clinical settings (Elendu et al., 2024)The incorporation of digital e-learning modules further supports self-directed learning, allowing learners to engage with content at their own pace and consolidate theoretical knowledge. Blended learning (BL) approaches have been shown in some studies to yield comparable or even superior outcomes in skill acquisition and learner satisfaction (Govindan et al., 2023)Conversely, other findings suggest that without adequate integration and institutional support, BL may fall short of its potential. Consequently, rigorous evaluation of BL against traditional educational methods is essential to establish its effectiveness and suitability as a standard approach in medical training. To address this gap in the literature, we plan to evaluate whether Blended Learning, encompassing digital e-learning modules and simulation-based training, is non-inferior to traditional SODO technique for essential skills among medical interns and anaesthesia trainees. This study will provide evidence that supports the integration of Blended Learning into medical training curricula, potentially enhancing the efficiency and accessibility of procedural education. |