Cognitive Function 1, SocialNCT03501641
Heart Rate Variability and Cognitive Load on Image-Based Virtual Reality Instructional Design in Otolaryngology
A study testing image-based virtual reality learning and video-based learning in people with Cognitive Function 1, Social and Competence, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function 1, Social, Competence, Heart Rate Fast
- What is being tested?
- image-based virtual reality learning and video-based learning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Apr 2018to 31 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of Heart Rate Variability and Cognitive Load on Image-Based Virtual Reality Instructional Design in Otolaryngology
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.
Read the 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.
- Conditions
- Cognitive Function 1, Social, Competence, Heart Rate Fast, Learning, Spatial, Otolaryngologic Disorder
- Being tested
- image-based virtual reality learning, video-based learning
- Keywords
- cognitive load, competence, heart rate variation, learning, otolaryngology, video, virtual reality
- Medical subject headings
- Tachycardia, Spatial Learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
image-based virtual reality learningOther
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 learningOther
voice of the staffs and standard patients.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: video-based learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: DOPS will be assessed immediately after intervention.
Secondary outcomes (11)
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).
Measured: The mini-CEX will be assessed immediately after intervention.
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).
Measured: The milestones will be assessed immediately after intervention.
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).
Measured: The CLS will be assessed immediately after intervention.
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).
Measured: The TLX will be assessed immediately after intervention.
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).
Measured: The CLC will be assessed immediately after intervention.
Bidirectional feedback and reflection
Bidirectional feedback and reflection will be immediate evaluated using a qualitative questionnaire after an intervention.
Measured: The bidirectional feedback and reflection will be assessed immediately after 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.
Measured: The GSS will be assessed immediately after 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.
Measured: The PQ will be assessed immediately after intervention.
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.
Measured: The HQ-S will be assessed immediately after intervention.
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.
Measured: The HQ-I will be assessed immediately after intervention.
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.
Measured: The ATT will be assessed immediately after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start24 Apr 2018
- Primary completion31 Jul 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cognitive Function 1, SocialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li-Ang Lee, MD, MSc, Principal investigator, Linkou Chang Gung Memorial Hospital, Taoyuan City 33305, Taiwan, ROC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501641
- Sponsor's protocol ID
- 201601821B0
- Status last verified
- Jan 2021
- First submitted
- 2 Apr 2018
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No.
Publications
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.
PubMed 40336062Chao 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.
PubMed 34813485
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Heart Rate Variability and Cognitive Load on Image-Based Virtual Reality Instructional Design in Otolaryngology
- ClinicalTrials.gov ID
- NCT03501641
- Acronym / sponsor ID
- 201601821B0
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| image-based virtual reality learning | Experimental | Other: image-based virtual reality learningThe participants will undergo 10-minute image-based virtual reality learning for history taking and physical examination of otolaryngology. |
| video-based learning | Active comparator | Other: video-based learningThe participants will undergo 10-minute video-based learning for history taking and physical examination of otolaryngology. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| image-based virtual reality learningThe 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). | Other | image-based virtual reality learning |
| video-based learningvoice of the staffs and standard patients. | Other | video-based learning |
Primary outcome
direct observation of procedural skills (DOPS)
Time frame: DOPS will be assessed immediately after intervention.
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).
11 secondary outcomes
Mini-clinical evaluation exercise (mini-CEX)
Time frame: The mini-CEX will be assessed immediately after intervention.
Milestones
Time frame: The milestones will be assessed immediately after intervention.
Cognitive Load Scale (CLS)
Time frame: The CLS will be assessed immediately after intervention.
Task Load Index (TLX)
Time frame: The TLX will be assessed immediately after intervention.
Cognitive Load Component (CLC)
Time frame: The CLC will be assessed immediately after intervention.
Bidirectional feedback and reflection
Time frame: The bidirectional feedback and reflection will be assessed immediately after intervention.
Global Satisfaction Scale (GSS)
Time frame: The GSS will be assessed immediately after intervention.
Pragmatic Quality (PQ)
Time frame: The PQ will be assessed immediately after intervention.
Hedonic Stimulation (HQ-S)
Time frame: The HQ-S will be assessed immediately after intervention.
Hedonic Identification (HQ-I)
Time frame: The HQ-I will be assessed immediately after intervention.
Attractiveness (ATT)
Time frame: The ATT will be assessed immediately after intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Derived from this study: PubMed 40336062Lin 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.
- Derived from this study: PubMed 34813485Chao 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.
- Individual participant dataSharing planned: Undecided. No.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li-Ang Lee, MD, MSc principal investigator
Linkou Chang Gung Memorial Hospital, Taoyuan City 33305, Taiwan, ROC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing image-based virtual reality learning and video-based learning in people with Cognitive Function 1, Social and Competence, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
direct observation of procedural skills (DOPS) (time frame: DOPS will be assessed immediately after intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03501641, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.