NCT06739590

Brief Summary

Background: Novice surgeons often struggle to translate anatomical knowledge into clinical practice, primarily due to a lack of resources, significant variability in anatomical structures, and limited hands-on experience. These challenges can lead to considerable deficiencies in clinical performance. Traditional educational methods, such as textbooks and CT imaging, frequently fall short in offering the depth necessary for effective application in surgical settings. Recent technological advancements, particularly in Augmented Reality (AR), Virtual Reality (VR), and Mixed Reality (MR), are revolutionizing surgical education by creating immersive learning environments. In complex fields like hepatobiliary surgery, the integration of MR allows for enhanced visualization of anatomical details, improving the understanding of vascular structures and tumor localization, which consequently boosts surgical training outcomes. However, most research to date has analyzed these technologies in isolation, with few studies investigating their collaborative benefits or effective integration into educational curricula. This study aims to evaluate cognitive learning outcomes related to anatomical structures by employing various modalities, including traditional medical imaging, 3D models, and 3D-MR. Through cross-comparative analyses, investigators will assess the correlation between test scores and actual clinical performance, thereby gauging the impact of these modalities on the comprehension of intricate anatomical structures and their spatial visualization skills. Ultimately, this study aspire to develop a comprehensive anatomical teaching program that incorporates MR and 3D models to demonstrate the feasibility and efficacy of these innovative technologies in teaching liver and gallbladder anatomy. Research Objectives: To compare the effectiveness of learning outcomes in anatomical structure learning between MR 3D modelling and general medical imaging, and to investigate which modalities lead to higher anatomical learning outcomes (primary outcome). Hypothesis: Compared to plain images, 3D models of MR simulators can significantly improve learning performance, achieve better learning outcomes

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

December 7, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 18, 2024

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2024

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2024

Completed
Last Updated

April 9, 2025

Status Verified

August 1, 2024

Enrollment Period

14 days

First QC Date

September 10, 2024

Last Update Submit

April 7, 2025

Conditions

Keywords

Medical EducationAnatomyTeaching InnovationSurgeon TrainingMixed Reality

Outcome Measures

Primary Outcomes (1)

  • Anatomical knowledge

    Anatomists create relevant test questions and assess performance of participants; by comparing the results of baseline and post-study score of the Anatomy and Surgical Competence Test. The improvement in test scores serves as an indicator for evaluating learning outcomes.

    Before and after the completion of the learning process, an average of 1 day

Secondary Outcomes (1)

  • Differences in Emotional Intensity

    Before and after the completion of the learning process, an average of 1 day

Study Arms (3)

Control Group

PLACEBO COMPARATOR

21 participants were allocated to this group. They completed a background questionnaire and assessed their baseline emotions using the Medical Emotions Scale (MES) before commencing the study. Participants then took a pre-study test assessing their spatial knowledge of hepatobiliary anatomy and a surgical planning component, based on their assigned group. Following the learning process on a sample case, they retook the MES and subsequently completed a test on the designated test cases.

Behavioral: Learning with CT scans

3D Group

EXPERIMENTAL

23 participants were allocated to this group. They completed a background questionnaire and assessed their baseline emotions using the MES prior to the study. They then completed a pre-study test focused on spatial knowledge of hepatobiliary anatomy and surgical planning. After engaging with the sample case, participants retook the MES and completed a test on the specified test cases. Intervention:Learning anatomical structures using three-dimensional visualization models displayed on a computer.

Behavioral: Learning with 3D visualization models

MR Group

EXPERIMENTAL

22 participants were allocated to this group. Participants completed a background questionnaire and assessed their baseline emotions using the MES before the study commenced. They participated in a training tutorial on utilizing the MR headset and completed a pre-study test evaluating spatial knowledge of hepatobiliary anatomy and surgical planning. After the learning process with the sample case, participants retook the MES, completed a test on the designated test cases, and filled out a post-use adverse reaction scale for the MR device. Intervention:Viewing and manipulating 3D visualization models to learn anatomical structures using the MR headset.

Radiation: Learning with 3D-MR visualization models

Interventions

The average performance improvement in this group will serve as the baseline for learning achievable through conventional CT and MR imaging alone.

Control Group

Learning anatomical structures using three-dimensional visualization models displayed on a computer.

3D Group

Viewing and manipulating 3D visualization models to learn anatomical structures using the MR headset.

MR Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Full-time undergraduate clinical medicine students
  • Postgraduate and trainees from accredited residency programs.

You may not qualify if:

  • Participants who had previously used the new technology or similar simulators
  • Participants lacking clinical anatomy learning experience.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510280, China

Location

Related Publications (6)

  • Balci D, Kirimker EO, Raptis DA, Gao Y, Kow AWC. Uses of a dedicated 3D reconstruction software with augmented and mixed reality in planning and performing advanced liver surgery and living donor liver transplantation (with videos). Hepatobiliary Pancreat Dis Int. 2022 Oct;21(5):455-461. doi: 10.1016/j.hbpd.2022.09.001. Epub 2022 Sep 8.

    PMID: 36123242BACKGROUND
  • Moro C, Stromberga Z, Raikos A, Stirling A. The effectiveness of virtual and augmented reality in health sciences and medical anatomy. Anat Sci Educ. 2017 Nov;10(6):549-559. doi: 10.1002/ase.1696. Epub 2017 Apr 17.

    PMID: 28419750BACKGROUND
  • Mateen M, Kan CYP. Education during COVID-19: Ready, headset, go! Clin Teach. 2021 Feb;18(1):90-91. doi: 10.1111/tct.13266. Epub 2020 Oct 2. No abstract available.

    PMID: 33006439BACKGROUND
  • Kolla S, Elgawly M, Gaughan JP, Goldman E. Medical Student Perception of a Virtual Reality Training Module for Anatomy Education. Med Sci Educ. 2020 Jun 9;30(3):1201-1210. doi: 10.1007/s40670-020-00993-2. eCollection 2020 Sep.

    PMID: 34457783BACKGROUND
  • Alharbi Y, Al-Mansour M, Al-Saffar R, Garman A, Alraddadi A. Three-dimensional Virtual Reality as an Innovative Teaching and Learning Tool for Human Anatomy Courses in Medical Education: A Mixed Methods Study. Cureus. 2020 Feb 24;12(2):e7085. doi: 10.7759/cureus.7085.

    PMID: 32226686BACKGROUND
  • Ammanuel S, Brown I, Uribe J, Rehani B. Creating 3D models from Radiologic Images for Virtual Reality Medical Education Modules. J Med Syst. 2019 May 3;43(6):166. doi: 10.1007/s10916-019-1308-3.

    PMID: 31053902BACKGROUND

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants remained unaware of the trial purpose and assessment metrics, only that they would be learning and practicing the anatomical structures and surgical planning of hepatobiliary surgery.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Stratified Randomized Block Design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2024

First Posted

December 18, 2024

Study Start

December 7, 2024

Primary Completion

December 21, 2024

Study Completion

December 27, 2024

Last Updated

April 9, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

Data obtained from primary and secondary outcomes may be shared if other researchers have an interest in this data.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
January 2025-January 2026
Access Criteria
Researchers wanting access to the data will need to contact the principal investigator of the trial. Dr. Jian Yang.

Locations