Heart Rate Variability and Cognitive Load on Image-Based Virtual Reality Instructional Design in Otolaryngology

NCT ID: NCT03501641

Last Updated: 2021-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-24

Study Completion Date

2020-10-31

Brief Summary

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This study aims to compare heart rate variation, cognitive load, and learning outcomes of novel image-based virtual reality with traditional video in learning for otolaryngology. Half of participants will receive image-based virtual reality learning, while the other half will receive video-based learning.

Detailed Description

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Background: Workplace-based assessments, such as mini-clinical evaluation exercise (mini-CEX), direct observation of procedural skills (DOPS), and milestones, target the highest level of clinical competence and collect information about doctors' performance in their normal practice. Recent advances in virtual reality (VR) simulation, lowering the complex of learning task and the cognitive load (CL) of the learner, make this novel technology well suited for the initial training of novices. Reduced heart rate variation (HRV), an indicator of stress, is associated with decreased cognitive efficiency in health. Accordingly, this study hypothesizes that VR-based instruction can help novices to increase HRV, decrease CL, and then improve their outcomes of workplace-based assessments.

Aims: This prospective study aims (1) to design an image-based VR (IBVR) instruction for clinical medical education, (2) to compare HRV and CL in traditional video-based (VB) learning and novel IBVR-based learning, (3) to compare outcomes of mini-CEX, DOPS, and milestone between two modules, (4) to perform a qualitative evaluation of IBVR-based learning using a 360-degree video review, and (5) to assess various levels of novice learners (undergraduate medical students and postgraduate year residents) for their participation in and acceptance of this novel IBVR-based learning.

Study Designs: This 3-year study includes two parts: (1) Design a VR-based curriculum including fundamental otolaryngological skills, and (2) Validation of an IBVR-based history taking and physical examination (H\&P) learning activity using a blinded randomized, parallel-controlled trial in convenience-sampled novice undergraduate medical students and postgraduate year residents.

Materials and Methods: This study will be implemented between August 1, 2017 and July 30, 2020. Firstly, a VR-based curriculum will be designed including H\&P using the analysis, design, development, implementation, and evaluation model and a modified Delphi approach. VB module and IBVR module of the same contexts will be developed. Secondly, an IBVR-based H\&P learning activity will be validated by measuring CL questionnaires, reaction time, HRV, mini-CEX, DOPS, milestones, global satisfaction scale and AttrakDiff2 questionnaires (n = 64). Age, sex, and cognitive style (determined by the Group Embedded Figures Test) of both groups are matched. Differences in variables of interests will be statistically analyzed.

Conditions

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Cognitive Function 1, Social Competence Heart Rate Fast Learning, Spatial Otolaryngologic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This randomized controlled trial will recruit 64 subjects who are novices in otolaryngology at an academic teaching hospital. The cognitive style of the participants is assessed using the Group Embedded Figures Test. The subjects are randomly assigned (1:1) to a novel image-based virtual reality group and conventional video-based group matched by age, sex, and cognitive style.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Blinding to the purpose of the study during recruitment is maintained to minimize preparation bias. After randomization, the participants are unblinded and use image-based virtual reality model or conventional video-based model on a virtual reality eyeglass in an ordinary office environment for 10 minutes. Heart rate variation will be monitored during learning and cognitive load will be assessed by the participants. Subsequently, each participant will perform history taking and physical examination for a real patient in a teaching clinic. The competence will be evaluated using the mini-clinical evaluation exercise, direct observation of procedural skills (DOPS), and milestone assessments. Investigators and outcome assessors are blinded to their randomization and learning models.

Study Groups

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image-based virtual reality learning

The participants will undergo 10-minute image-based virtual reality learning for history taking and physical examination of otolaryngology.

Group Type EXPERIMENTAL

image-based virtual reality learning

Intervention Type OTHER

The participants will use a whole-view, 360 degree image-based virtual reality to learn a competence of history taking and physical examination for otolaryngology and they can see the response of the staffs and standard patients (including image, voice, face expression, movement, ... etc).

video-based learning

The participants will undergo 10-minute video-based learning for history taking and physical examination of otolaryngology.

Group Type ACTIVE_COMPARATOR

video-based learning

Intervention Type OTHER

voice of the staffs and standard patients.

Interventions

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image-based virtual reality learning

The participants will use a whole-view, 360 degree image-based virtual reality to learn a competence of history taking and physical examination for otolaryngology and they can see the response of the staffs and standard patients (including image, voice, face expression, movement, ... etc).

Intervention Type OTHER

video-based learning

voice of the staffs and standard patients.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age \> 20 years old;
2. Undergraduate medical students (defined as the last year of medical school training) and postgraduate year residents (defined as the first year after graduation).

Exclusion Criteria

1. Pregnant, hypertension, recent motion sickness, inner ear infections or claustrophobia, recent surgery, pre-existing binocular vision abnormalities, heart conditions or epileptic symptoms;
2. Declining to participate.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li-Ang Lee, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Linkou Chang Gung Memorial Hospital, Taoyuan City 33305, Taiwan, ROC

Locations

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Linkou Chang Gung Memorial Hospital

Taoyuan, , Taiwan

Site Status

Countries

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Taiwan

References

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Lin WN, Chuang HH, Chao YP, Hsin LJ, Kang CJ, Fang TJ, Li HY, Lee LA. Image-based and textbook-based virtual reality training on operational skills among junior residents: a proof of concept study. BMC Med Educ. 2025 May 7;25(1):668. doi: 10.1186/s12909-025-07245-0.

Reference Type DERIVED
PMID: 40336062 (View on PubMed)

Chao YP, Chuang HH, Hsin LJ, Kang CJ, Fang TJ, Li HY, Huang CG, Kuo TBJ, Yang CCH, Shyu HY, Wang SL, Shyu LY, Lee LA. Using a 360 degrees Virtual Reality or 2D Video to Learn History Taking and Physical Examination Skills for Undergraduate Medical Students: Pilot Randomized Controlled Trial. JMIR Serious Games. 2021 Nov 22;9(4):e13124. doi: 10.2196/13124.

Reference Type DERIVED
PMID: 34813485 (View on PubMed)

Other Identifiers

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201601821B0

Identifier Type: -

Identifier Source: org_study_id

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