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

Primary Purpose

Cognitive Function 1, Social, Competence, Heart Rate Fast

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
image-based virtual reality learning
video-based learning
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cognitive Function 1, Social focused on measuring cognitive load, competence, heart rate variation, learning, otolaryngology, video, virtual reality

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Linkou Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

image-based virtual reality learning

video-based learning

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Mini-clinical evaluation exercise (mini-CEX)
Skills of history taking and physical examination for otolaryngology will be evaluated using a mini-CEX assessment immediately after a mini-clinical exercise. The Mini-CEX is a 10-minute direct observation assessment. This assessment uses seven items (interview, physical examination, professionalism, clinical diagnosis, explanation, efficiency, and global assessment) with 9 (1-9) Likert scales (range: 7-63).
Milestones
Overall competence of history taking and physical examination for otolaryngology will be immediately evaluated using an assessment of milestones after a 10-minute mini-clinical exercise. This assessment uses five Likert-type levels (basic, focuses, appropriate, accurate, professional) (range: 1-5).
Cognitive Load Scale (CLS)
Cognitive load of the specific intervention will be immediately evaluated using the Paas CLS questionnaire after an intervention. The Paas CLS questionnaire is a single-item measure of total cognitive load. Participants are asked to rate the perceived intensity of their mental effort with 9 Likert scales (1 = very, very low mental effort; 9 = very, very high mental effort).
Task Load Index (TLX)
Task Load of the specific intervention will be evaluated using the National Aeronautics and Space Administration TLX questionnaire after an intervention. The questionnaire has six subscales: mental demand; physical demand; temporal demand; performance; effort, and frustration. Participants are asked to indicate the level of each dimension by making a mark on a visual analogue scale with a 21-point Likert scale (range: 0-20). Total cognitive load is interpreted as the sum of the six subscales (range: 0-120).
Cognitive Load Component (CLC)
Component of cognitive load of the specific intervention will be immediately evaluated using the CLC questionnaire after an intervention. The CLC questionnaire has six subscales: difficulty, complexity, clarity, relevance, focus, and learning with 5 Likert scales (range: 6-30).
Bidirectional feedback and reflection
Bidirectional feedback and reflection will be immediate evaluated using a qualitative questionnaire after an intervention.
Global Satisfaction Scale (GSS)
Global satisfaction of the specific intervention will be immediately evaluated using the GSS questionnaire with 11 Likert scales (range: 0-10) after an intervention.
Pragmatic Quality (PQ)
PQ of the specific intervention will be immediately evaluated using the AttrakDiff2 questionnaire after an intervention. The AttrakDiff2 questionnaire contains 28 questions with 7 Likert-type scales. A PQ scale ranges from -3 to 3.
Hedonic Stimulation (HQ-S)
HQ-S of the specific intervention will be immediately evaluated using the AttrakDiff2 questionnaire after an intervention. The AttrakDiff2 questionnaire contains 28 questions with 7 Likert-type scales. A HQ-S scale ranges from -3 to 3.
Hedonic Identification (HQ-I)
HQ-I of the specific intervention will be immediately evaluated using the AttrakDiff2 questionnaire after an intervention. The AttrakDiff2 questionnaire contains 28 questions with 7 Likert-type scales. A HQ-I scale ranges from -3 to 3.
Attractiveness (ATT)
ATT of the specific intervention will be immediately evaluated using the AttrakDiff2 questionnaire after an intervention. The AttrakDiff2 questionnaire contains 28 questions with 7 Likert-type scales. A ATT scale ranges from -3 to 3.

Full Information

First Posted
April 2, 2018
Last Updated
January 27, 2021
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03501641
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 24, 2018 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
October 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Function 1, Social, Competence, Heart Rate Fast, Learning, Spatial, Otolaryngologic Disorder
Keywords
cognitive load, competence, heart rate variation, learning, otolaryngology, video, virtual reality

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
image-based virtual reality learning
Arm Type
Experimental
Arm Description
The participants will undergo 10-minute image-based virtual reality learning for history taking and physical examination of otolaryngology.
Arm Title
video-based learning
Arm Type
Active Comparator
Arm Description
The participants will undergo 10-minute video-based learning for history taking and physical examination of otolaryngology.
Intervention Type
Other
Intervention Name(s)
image-based virtual reality learning
Intervention Description
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
Intervention Name(s)
video-based learning
Intervention Description
voice of the staffs and standard patients.
Primary Outcome Measure Information:
Title
direct observation of procedural skills (DOPS)
Description
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).
Time Frame
DOPS will be assessed immediately after intervention.
Secondary Outcome Measure Information:
Title
Mini-clinical evaluation exercise (mini-CEX)
Description
Skills of history taking and physical examination for otolaryngology will be evaluated using a mini-CEX assessment immediately after a mini-clinical exercise. The Mini-CEX is a 10-minute direct observation assessment. This assessment uses seven items (interview, physical examination, professionalism, clinical diagnosis, explanation, efficiency, and global assessment) with 9 (1-9) Likert scales (range: 7-63).
Time Frame
The mini-CEX will be assessed immediately after intervention.
Title
Milestones
Description
Overall competence of history taking and physical examination for otolaryngology will be immediately evaluated using an assessment of milestones after a 10-minute mini-clinical exercise. This assessment uses five Likert-type levels (basic, focuses, appropriate, accurate, professional) (range: 1-5).
Time Frame
The milestones will be assessed immediately after intervention.
Title
Cognitive Load Scale (CLS)
Description
Cognitive load of the specific intervention will be immediately evaluated using the Paas CLS questionnaire after an intervention. The Paas CLS questionnaire is a single-item measure of total cognitive load. Participants are asked to rate the perceived intensity of their mental effort with 9 Likert scales (1 = very, very low mental effort; 9 = very, very high mental effort).
Time Frame
The CLS will be assessed immediately after intervention.
Title
Task Load Index (TLX)
Description
Task Load of the specific intervention will be evaluated using the National Aeronautics and Space Administration TLX questionnaire after an intervention. The questionnaire has six subscales: mental demand; physical demand; temporal demand; performance; effort, and frustration. Participants are asked to indicate the level of each dimension by making a mark on a visual analogue scale with a 21-point Likert scale (range: 0-20). Total cognitive load is interpreted as the sum of the six subscales (range: 0-120).
Time Frame
The TLX will be assessed immediately after intervention.
Title
Cognitive Load Component (CLC)
Description
Component of cognitive load of the specific intervention will be immediately evaluated using the CLC questionnaire after an intervention. The CLC questionnaire has six subscales: difficulty, complexity, clarity, relevance, focus, and learning with 5 Likert scales (range: 6-30).
Time Frame
The CLC will be assessed immediately after intervention.
Title
Bidirectional feedback and reflection
Description
Bidirectional feedback and reflection will be immediate evaluated using a qualitative questionnaire after an intervention.
Time Frame
The bidirectional feedback and reflection will be assessed immediately after intervention.
Title
Global Satisfaction Scale (GSS)
Description
Global satisfaction of the specific intervention will be immediately evaluated using the GSS questionnaire with 11 Likert scales (range: 0-10) after an intervention.
Time Frame
The GSS will be assessed immediately after intervention.
Title
Pragmatic Quality (PQ)
Description
PQ of the specific intervention will be immediately evaluated using the AttrakDiff2 questionnaire after an intervention. The AttrakDiff2 questionnaire contains 28 questions with 7 Likert-type scales. A PQ scale ranges from -3 to 3.
Time Frame
The PQ will be assessed immediately after intervention.
Title
Hedonic Stimulation (HQ-S)
Description
HQ-S of the specific intervention will be immediately evaluated using the AttrakDiff2 questionnaire after an intervention. The AttrakDiff2 questionnaire contains 28 questions with 7 Likert-type scales. A HQ-S scale ranges from -3 to 3.
Time Frame
The HQ-S will be assessed immediately after intervention.
Title
Hedonic Identification (HQ-I)
Description
HQ-I of the specific intervention will be immediately evaluated using the AttrakDiff2 questionnaire after an intervention. The AttrakDiff2 questionnaire contains 28 questions with 7 Likert-type scales. A HQ-I scale ranges from -3 to 3.
Time Frame
The HQ-I will be assessed immediately after intervention.
Title
Attractiveness (ATT)
Description
ATT of the specific intervention will be immediately evaluated using the AttrakDiff2 questionnaire after an intervention. The AttrakDiff2 questionnaire contains 28 questions with 7 Likert-type scales. A ATT scale ranges from -3 to 3.
Time Frame
The ATT will be assessed immediately after intervention.
Other Pre-specified Outcome Measures:
Title
Heart Rate Variation
Description
Before and during an intervention, heart rate is continuously recorded. Heart rate variations will be calculated at baseline and during the specific intervention.
Time Frame
At baseline for 2 minutes and during an intervention for 10 minutes.
Title
Reaction time
Description
The dual-task paradigm with reaction time measurement is manually measured (seconds).
Time Frame
At baseline, the 5th minute and the 10th time.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li-Ang Lee, MD, MSc
Organizational Affiliation
Linkou Chang Gung Memorial Hospital, Taoyuan City 33305, Taiwan, ROC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Linkou Chang Gung Memorial Hospital
City
Taoyuan City
ZIP/Postal Code
33305
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
No.
Citations:
PubMed Identifier
34813485
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.
Results Reference
derived

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

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