Clinical trial NCT03501641: Heart Rate Variability and Cognitive Load on Image-Based Virtual Reality Instructional Design in Otolaryngology
Official title: A Study of Heart Rate Variability and Cognitive Load on Image-Based Virtual Reality Instructional Design in Otolaryngology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: direct observation of procedural skills (DOPS)
timeFrame: DOPS will be assessed immediately after intervention.
Secondary outcomes:
measure: Mini-clinical evaluation exercise (mini-CEX)
timeFrame: The mini-CEX will be assessed immediately after intervention.
measure: Milestones
timeFrame: The milestones will be assessed immediately after intervention.
measure: Cognitive Load Scale (CLS)
timeFrame: The CLS will be assessed immediately after intervention.
measure: Task Load Index (TLX)
timeFrame: The TLX will be assessed immediately after intervention.
measure: Cognitive Load Component (CLC)
timeFrame: The CLC will be assessed immediately after intervention.
measure: Bidirectional feedback and reflection
timeFrame: The bidirectional feedback and reflection will be assessed immediately after intervention.
measure: Global Satisfaction Scale (GSS)
timeFrame: The GSS will be assessed immediately after intervention.
measure: Pragmatic Quality (PQ)
timeFrame: The PQ will be assessed immediately after intervention.
measure: Hedonic Stimulation (HQ-S)
timeFrame: The HQ-S will be assessed immediately after intervention.
measure: Hedonic Identification (HQ-I)
timeFrame: The HQ-I will be assessed immediately after intervention.
measure: Attractiveness (ATT)
timeFrame: The ATT will be assessed immediately after intervention.
Other outcomes:
measure: Heart Rate Variation
timeFrame: At baseline for 2 minutes and during an intervention for 10 minutes.
measure: Reaction time
timeFrame: At baseline, the 5th minute and the 10th time.
Locations:
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
Study officials:
affiliation: Linkou Chang Gung Memorial Hospital, Taoyuan City 33305, Taiwan, ROC
name: Li-Ang Lee, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.