| CTRI Number |
CTRI/2025/10/096278 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
03/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [ACME project for FDP by NMC comparing two medical education simulation teaching methods] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two simulation teaching techniques for acquiring basic robotic surgery skills among postgraduate students in general surgery |
|
Scientific Title of Study
|
Comparison of Interleaved Technique with Spacing (ILS) versus Massed Technique with Spacing (MTS) for acquisition of basic robotic surgery skills among postgraduate students in general surgery. |
| 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 Swati Ghanshyam Deshpande |
| Designation |
Associate Professor, General Surgery |
| Affiliation |
Jawaharlar Nehru Medical College, Sawangi Meghe, Wardha |
| Address |
Department of General Surgery,
Jawaharlal Nehru Medical College, DMIHER( DU),
Sawangi Meghe, Wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
9969274572 |
| Fax |
|
| Email |
swati.surgery@dmiher.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Chandrasekhar Mahakalkar |
| Designation |
Professor, General Surgery and Director, Hospitals, DMIHER (DU) |
| Affiliation |
Jawaharlar Nehru Medical College, Sawangi Meghe, Wardha |
| Address |
Department of General Surgery,
Jawaharlal Nehru Medical College, DMIHER( DU),
Sawangi Meghe, Wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
9822369277 |
| Fax |
|
| Email |
directorhospitals@dmiher.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Swati Ghanshyam Deshpande |
| Designation |
Associate Professor, General Surgery |
| Affiliation |
Jawaharlar Nehru Medical College, Sawangi Meghe, Wardha |
| Address |
Department of General Surgery,
Jawaharlal Nehru Medical College, DMIHER( DU),
Sawangi Meghe, Wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
9969274572 |
| Fax |
|
| Email |
swati.surgery@dmiher.edu.in |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, DMIHER(DU), Sawangi Meghe, Wardha |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College, DMIHER(DU), Sawangi Meghe, Wardha |
| Address |
Department of General Surgery,
Jawaharlal Nehru Medical College, DMIHER(DU),Sawangi Meghe, Wardha |
| Type of Sponsor |
Private medical college |
|
|
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 Swati Ghanshyam Deshpande |
Jawaharlal Nehru Medical College |
Robotic Console room, OT Complex, NSB Building, AVBRH, JNMC Wardha MAHARASHTRA |
9969274572
swati.surgery@dmiher.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, DMIHER(DU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL, Studying efficacy of two simulation teaching techniques in postgraduates in general surgery |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Interleaved Technique and Spacing |
Each session will contain short blocks of all three tasks in interleaved order (e.g., R1 followed by R2 followed by R3).
Example session: three 12-minute task blocks + 3-minute buffer or feedback equal to 45 minutes.
Task order randomized each session to ensure mixing.
|
| Comparator Agent |
Massed Technique and Spacing |
Each session focuses on a single task per session. The curriculum cycles tasks across sessions by week but within a session participants practice one task repeatedly (massed within session)
Example schedule across 3 sessions: Session 1: Task R1 x 3; Session 2: Task R2 x 3; Session 3: Task R3 x 3.
Each session: three consecutive blocks on same task with short breaks (approx. same total practice time per task as Group A)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Postgraduate students in general surgery at the study centre.
2. Provide written informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Prior formal robotic console credentialing
2. Temporary disability due to any reason.
3. Declines consent or planning leave greater than 25 percent of training period.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| •Mean number of attempts required to pass the R4 task during training, as assessed by the Virtual Trainer. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Attempts needed and accuracy for each task (R1–R3/R4) as per the Virtual Trainer. |
4 weeks |
| 2. Number of attempts required to pass the R4 task. |
4 weeks |
| 3. Proportion of postgraduates passing the R4 task on the first attempt. |
4 weeks |
| 4. Identification of the easiest and most difficult parameters to pass among the four tasks, based on attempts required. |
4 weeks |
| 5. Performance on the R4 task in terms of completion time, error count, and accuracy. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="24" Sample Size from India="24"
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)
|
01/11/2025 |
| 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="0" Months="6" 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 inclusion of Robotic assisted surgery as a part of surgical armamentarium over the last few decades has necessitated the acquisition of a wide range of psychomotor skills. The traditional training approach used for open surgeries of “see one, do one, teach one” is not efficient and carries a risk with increased focus on patient safety and unwillingness to be "practised" on. Repetitive practice makes perfect and it has consistently proven to improve psychomotor skills. However, psychomotor skills needed for Minimal access surgery (MAS) including robotics are more complex than open surgery. Studies suggest that 8% will not be able to learn MAS skills, despite adequate and appropriate training (1). This is because the most notable differences include loss of haptic feedback; need to learn multiple small tasks to perform single movement using different parts of hand controller, thus requiring the development of hand–eye coordination (1). Simulation is defined as "a person, device, or set of conditions which attempts to present education and evaluation problems authentically". It is an effective and safe tool for training and assessment. Various teaching learning techniques include deliberate or distributed practice or spaced repetition, blocked or massed practice and interleaved practice. Simulation-based training has become an integral part of the many procedural and surgical skills training as it provides the students and young surgeons an opportunity to acquire their skills in a safe and stress-free environment. It is unclear whether spaced interleaving techniques or spaced blocked techniques will be more efficient in performance of a combined activity needed in robotic simulation and be translated into clinical operative outcomes. This study compares interleaved technique + spacing with massed technique + spacing for acquisition of basic robotic skills in postgraduate students in general surgery. Review of literature: Robotic assisted surgery involves a surgeon sitting on a console and operating on the patient remotely via use of robotic arms controlled by the hand controller. This differs from the traditional open surgery or laparoscopic surgery where the surgeon stands at the bedside and directly handles the tissue via hand held instruments. Robotic surgery training requires acquisition of fine motor skills, 3D depth perception, camera control and bimanual dexterity. Virtual training platforms are used to teach these skills of robotic surgery to learners. These training sessions include various task-based modules in an incrementally sequential manner such that combination of two or more tasks are needed to accomplish a single step in a robotic procedure. There is no unified curriculum which describes the best method for teaching and learning these tasks. Various teaching methods like interleaved technique, massed technique with or without spacing can be used for this purpose. Massed practice refers to a practice schedule that allows no periods of rest in between practice, whereas distributed practice or spacing refers to a schedule where periods of practice are interspersed with periods of rest (2). Interleaving is studying between different skills in a single session. To optimise the experience of postgraduates in skills training, flexible and feasible training methods are required. The training schedules for simulation training has shown to influence the acquisition and retention of psychomotor as well as cognitive skills. Studies within these domains suggest that distributed practice is superior to massed practice for tasks like typing, ball toss, and second-language learning (3,4). This has showed to improve acquisition, association of various tasks, short term and long-term retention of skills through cumulative beneficial effect. Surgical skills training is often conducted using a blocked or a massed approach (5). Distributed practice has shown to be more effective for skills acquisition than massed training. Spacing practice of laparoscopic motor skill training facilitates skill acquisition, short-term and long-term retention, and thus, a more efficient learning process for trainees. This using a spaced repetition schedule with massed technique or interleaved technique may have benefits and increase skill retention (6). Educational literature suggests that practice schedules (interleaved vs. massed) and spacing between training sessions influence skill acquisition and retention. Interleaved practice (mixing tasks within sessions) can improve transfer and discrimination, while massed practice (repeating the same task) often improves immediate performance but may reduce transfer. Combining either schedule with spacing (distributed sessions) may further affect learning. Moulton et al. in their study favoured that distributed schedule leads to better performance than a massed schedule for bronchoscopy skills (7). As per Crochet et al, VR training improved dexterity for both groups of deliberate practice and control group with higher dexterity and superior transfer of skills in deliberate practice group (8). However, it is still not known as to which is the most effective practice schedule for learning robotic skills through simulation training. This study compares two distributed practice schedules- Interleaved technique with spacing and massed technique with spacing for acquisition of robotic surgery skills by postgraduates in general surgery. Need/Rationale of study: This study will help compare interleaved technique + spacing with massed technique + spacing for acquisition of basic robotic skills in postgraduate students in general surgery. Aim: To compare the effectiveness of interleaved practice with spacing versus massed practice with spacing in the acquisition of basic robotic surgery skills among postgraduate students in general surgery. |