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

NCT03501641 | Completed

• 1 other identifier: 201601821B0
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

cognitive load; competence; heart rate variation; learning; otolaryngology; video; virtual reality

Outcome Measures

Primary Outcomes (1)

• direct observation of procedural skills (DOPS)

  Procedural skills of history taking and physical examination for otolaryngology will be evaluated using a DOPS assessment immediately after a 10-minute mini-clinical exercise. This assessment uses ten items (indication, explanation, preparation, sites, aseptic/safe procedure, completeness, request for help, recording, interpretation, and global assessment) with 10 (1-10) Likert scales (range: 10-100).

  DOPS will be assessed immediately after intervention.

Secondary Outcomes (11)

• Mini-clinical evaluation exercise (mini-CEX)

  The mini-CEX will be assessed immediately after intervention.

• Milestones

  The milestones will be assessed immediately after intervention.

• Cognitive Load Scale (CLS)

  The CLS will be assessed immediately after intervention.

• Task Load Index (TLX)

  The TLX will be assessed immediately after intervention.

• Cognitive Load Component (CLC)

  The CLC will be assessed immediately after intervention.

Other Outcomes (2)

• Heart Rate Variation

  At baseline for 2 minutes and during an intervention for 10 minutes.

• Reaction time

  At baseline, the 5th minute and the 10th time.

Study Arms (2)

image-based virtual reality learning

EXPERIMENTAL

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

Other: image-based virtual reality learning

video-based learning

ACTIVE COMPARATOR

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

Other: video-based learning

Interventions

image-based virtual reality learning 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).

image-based virtual reality learning

video-based learning OTHER

voice of the staffs and standard patients.

video-based learning

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Linkou Chang Gung Memorial Hospital

Taoyuan, 33305, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 40336062 DERIVED

• 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.

  PMID: 34813485 DERIVED

MeSH Terms

Conditions

Tachycardia; Spatial Learning

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Spatial Behavior; Behavior

Study Officials

• Li-Ang Lee, MD, MSc

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 2, 2018
• First Posted: April 18, 2018
• Study Start: April 24, 2018
• Primary Completion: July 31, 2020
• Study Completion: October 31, 2020
• Last Updated: February 1, 2021

Record last verified: 2021-01

Locations

TW (1)